Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3

Summary

The FDA issued a Class II for Crome Models loaded with CareLink SmartSync Device Manager application software by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Reason: Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy de.

Details

Product Description

Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1

Lot/Code Info: a) Crome VR: DVPC3D1, DVPC3D4; Model DVPC3D1: GTIN 00763000178536, Serial Numbers: RSG600215S, RSG600212S, RSG600196S, RSG600280S, RSG600223S, RSG600208S, RSG600106S, RSG600094S, RSG600125S, RSG600193S, RSG600006S, RSG600123S, RSG600016S, RSG600136S, RSG600249S, RSG600113S, RSG600395S, RSG600173S, RSG600118S, RSG600116S, RSG600112S, RSG600130S, RSG600111S, RSG600191S, RSG600205S, RSG600143S, RSG600175S, RSG600209S, RSG600272S, RSG600167S, RSG600187S, RSG600077S, RSG600162S, RSG600253S, RSG600245S, RSG600131S, RSG600145S, RSG600237S, RSG600107S, RSG600220S, RSG600037S, RSG600119S, RSG600144S, RSG600231S, RSG600163S, RSG600185S, RSG600210S, RSG600148S, RSG600171S, RSG600157S, RSG600172S, RSG600137S, RSG600201S, RSG600190S, RSG600114S, RSG600247S, RSG600183S, RSG600278S, RSG600243S, RSG600246S, RSG600166S, RSG600152S, RSG600228S, RSG600204S, RSG600242S, RSG600126S, RSG600141S, RSG600138S, RSG600174S, RSG600122S, RSG600200S, RSG600225S, RSG600232S, RSG600140S, RSG600233S, RSG600086S, RSG600083S, RSG600250S, RSG600178S, RSG600134S, RSG600168S, RSG600117S, RSG600110S, RSG600115S, RSG600109S, RSG600255S, RSG600108S, RSG600164S, RSG600159S, RSG600158S, RSG600219S, RSG600181S, RSG600132S, RSG600240S, RSG600186S, RSG600121S, RSG600179S, RSG600055S; GTIN 00763000178543, Serial Numbers: RSG600313S, RSG600079S, RSG600306S, RSG600105S, RSG600103S, RSG600317S, RSG600379S, RSG600330S, RSG600063S, RSG600315S, RSG600316S, RSG600335S, RSG600334S, RSG600333S, RSG600332S, RSG600311S, RSG600444S, RSG600050S, RSG600070S, RSG600320S, RSG600052S, RSG600327S, RSG600371S, RSG600319S, RSG600089S, RSG600041S, RSG600039S, RSG600057S, RSG600054S, RSG600053S, RSG600072S, RSG600383S, RSG600324S, RSG600445S, RSG600325S, RSG600314S, RSG600087S, RSG600322S, RSG600073S, RSG600382S, RSG600363S, RSG600337S, RSG600025S, RSG600368S, RSG600084S, RSG600013S, RSG600008S, RSG600009S, RSG600029S, RSG600014S, RSG600007S, RSG600012S, RSG600042S, RSG600023S, RSG600026S, RSG600024S, RSG600404S, RSG600377S, RSG600458S, RSG600366S, RSG600028S, RSG600398S, RSG600374S, RSG600074S, RSG600059S, RSG600098S, RSG600088S, RSG600040S, RSG600412S, RSG600033S, RSG600018S, RSG600020S, RSG600402S, RSG600060S, RSG600011S, RSG600022S, RSG600049S, RSG600367S, RSG600010S, RSG600058S, RSG600043S, RSG600045S, RSG600397S, RSG600400S, RSG600360S, RSG600359S, RSG600351S, RSG600394S, RSG600355S, RSG600361S, RSG600354S, RSG600350S, RSG600357S, RSG600451S, RSG600358S, RSG600352S, RSG600448S, RSG600432S, RSG600430S, RSG600469S, RSG600471S, RSG600431S, RSG600470S, RSG600415S, RSG600427S, RSG600429S, RSG600428S, RSG600439S, RSG600461S, RSG600388S, RSG600434S, RSG600390S, RSG600447S, RSG600449S, RSG600387S, RSG600440S, RSG600391S, RSG600389S, RSG600452S, RSG600459S, RSG600386S, RSG600464S, RSG600410S, RSG600407S, RSG600408S, RSG600453S, RSG600463S, RSG600441S, RSG600419S, RSG600422S, RSG600353S, RSG600362S, RSG600446S, RSG600406S, RSG600409S, RSG600411S, RSG600454S, RSG600347S, RSG600349S, RSG600414S, RSG600467S, RSG600466S, RSG600465S, RSG600460S, RSG600457S, RSG600456S, RSG600413S, RSG600426S, RSG600462S, RSG600474S, RSG600385S, RSG600380S, RSG600472S, RSG600373S, RSG600381S, RSG600393S, RSG600392S, RSG600437S, RSG600438S, RSG600423S, RSG600433S, RSG600421S, RSG600425S, RSG600436S, RSG600418S, RSG600396S, RSG600424S, RSG600420S, RSG600417S, RSG600056S, RSG600376S, RSG600384S, RSG600405S, RSG600442S, RSG600027S, RSG600017S, RSG600310S, RSG600364S, RSG600066S, RSG600365S, RSG600435S, RSG600348S, RSG600356S, RSG600450S, RSG600036S, RSG600305S, RSG600375S, RSG600399S, RSG600403S, RSG600401S, RSG600101S, RSG600370S, RSG600047S, RSG600030S, RSG600075S, RSG600031S, RSG600065S, RSG600068S; Model DVPC3D4: GTIN 00763000178550, Serial Numbers: RSH600068S, RSH600173S, RSH600239S, RSH600903S, RSH600064S, RSH600099S, RSH601021S, RSH600917S, RSH600175S, RSH600276S, RSH600174S, RSH600275S, RSH600889S, RSH600228S, RSH601052S, RSH601039S, RSH600071S, RSH600816S, RSH600906S, RSH601034S, RSH600922S, RSH601041S, RSH600910S, RSH600821S, RSH600007S, RSH600082S, RSH600110S, RSH600236S, RSH600264S, RSH600830S, RSH600181S, RSH600827S, RSH600057S, RSH601024S, RSH600211S, RSH601036S, RSH600887S, RSH600124S, RSH600147S, RSH600101S, RSH600066S, RSH600097S, RSH600041S, RSH600103S, RSH600108S, RSH600067S, RSH600117S, RSH600126S, RSH600109S, RSH600131S, RSH600086S, RSH600157S, RSH600145S, RSH600130S, RSH600188S, RSH600207S, RSH600240S, RSH600222S, RSH600204S, RSH600225S, RSH600829S, RSH600045S, RSH600055S, RSH600102S, RSH600142S, RSH601023S, RSH600199S, RSH601058S, RSH600171S, RSH600169S, RSH600815S, RSH600172S, RSH600238S, RSH600219S, RSH600135S, RSH600921S, RSH600849S, RSH600891S, RSH600278S, RSH600132S, RSH600261S, RSH600089S, RSH600043S, RSH600262S, RSH601030S, RSH600911S, RSH600170S, RSH600820S, RSH600205S, RSH600196S, RSH600049S, RSH600048S, RSH600056S, RSH600065S, RSH600046S, RSH600074S, RSH600153S, RSH600047S, RSH600158S, RSH601026S, RSH600143S, RSH600192S, RSH601027S, RSH600061S, RSH600168S, RSH600912S, RSH600277S, RSH600139S, RSH600114S, RSH600100S, RSH600183S, RSH600080S, RSH600094S, RSH601028S, RSH600134S, RSH600260S, RSH600215S, RSH601051S, RSH601032S, RSH601031S, RSH600823S, RSH600177S, RSH600078S, RSH600818S, RSH600039S, RSH600194S, RSH600819S, RSH600166S, RSH600176S, RSH600053S, RSH600920S, RSH600138S, RSH600059S, RSH600882S, RSH600072S, RSH600258S, RSH601035S, RSH600907S, RSH600231S, RSH600257S, RSH600251S, RSH600230S, RSH600182S, RSH600253S, RSH600828S, RSH600060S, RSH600092S, RSH600165S, RSH600221S, RSH600150S, RSH600076S, RSH600112S, RSH600113S, RSH600077S, RSH600084S, RSH600093S, RSH600822S, RSH601033S, RSH600058S, RSH600280S, RSH600054S, RSH600063S, RSH600149S, RSH600120S, RSH600125S, RSH600119S, RSH600141S, RSH600282S, RSH600824S, RSH600197S, RSH600281S, RSH600195S, RSH600062S, RSH600069S, RSH600895S, RSH600831S, RSH600908S, RSH600879S, RSH600832S, RSH600208S, RSH600825S, RSH600111S, RSH600506S, RSH600162S, RSH600833S, RSH600151S, RSH600184S, RSH601025S, RSH600159S, RSH600091S, RSH600107S, RSH600164S, RSH600148S, RSH600070S, RSH600152S, RSH600129S, RSH600128S, RSH600036S, RSH600122S, RSH600140S, RSH600105S, RSH600123S, RSH600259S, RSH601022S, RSH600161S, RSH600073S, RSH600136S, RSH600901S; GTIN 00763000178567, Serial Numbers: RSH600793S, RSH600640S, RSH600589S, RSH600762S, RSH600651S, RSH600659S, RSH600692S, RSH600766S, RSH600639S, RSH600694S, RSH600763S, RSH600959S, RSH600648S, RSH600948S, RSH600930S, RSH600929S, RSH600942S, RSH600864S, RSH600758S, RSH600574S, RSH600714S, RSH600722S, RSH600667S, RSH600726S, RSH600995S, RSH600742S, RSH600801S, RSH600666S, RSH600654S, RSH600817S, RSH600642S, RSH600782S, RSH600689S, RSH600641S, RSH600685S, RSH600932S, RSH600854S, RSH600675S, RSH600935S, RSH600030S, RSH600936S, RSH600710S, RSH600806S, RSH600673S, RSH601004S, RSH600553S, RSH600653S, RSH600787S, RSH600800S, RSH600676S, RSH600283S, RSH600962S, RSH600359S, RSH600270S, RSH600418S, RSH600415S, RSH600414S, RSH600412S, RSH600406S, RSH600190S, RSH600537S, RSH600452S, RSH600601S, RSH600650S, RSH600548S, RSH600993S, RSH600664S, RSH600401S, RSH600583S, RSH600584S, RSH600645S, RSH600871S, RSH601070S, RSH600671S, RSH600647S, RSH601009S, RSH600635S, RSH600657S, RSH600656S, RSH600655S, RSH600658S, RSH600923S, RSH600698S, RSH600210S, RSH600812S, RSH600396S, RSH600983S, RSH600979S, RSH600633S, RSH600378S, RSH600377S, RSH601060S, RSH601057S, RSH600643S, RSH601061S, RSH600858S, RSH600006S, RSH600357S, RSH600374S, RSH600373S, RSH600419S, RSH600426S, RSH600383S, RSH600797S, RSH600773S, RSH600632S, RSH600996S, RSH600619S, RSH600934S, RSH600638S, RSH600033S, RSH600024S, RSH600721S, RSH600503S, RSH600497S, RSH600861S, RSH601018S, RSH600382S, RSH600572S, RSH600279S, RSH600273S, RSH600454S, RSH600413S, RSH600542S, RSH600557S, RSH600753S, RSH600839S, RSH600202S, RSH600804S, RSH600245S, RSH600227S, RSH600355S, RSH600398S, RSH600463S, RSH600530S, RSH600554S, RSH600538S, RSH600610S, RSH600723S, RSH600865S, RSH600388S, RSH600842S, RSH600012S, RSH600453S, RSH600606S, RSH600899S, RSH600023S, RSH600021S, RSH600404S, RSH600408S, RSH600534S, RSH600743S, RSH600543S, RSH600564S, RSH600596S, RSH600881S, RSH600795S, RSH600857S, RSH600913S, RSH600027S, RSH600011S, RSH600028S, RSH600032S, RSH600200S, RSH600456S, RSH600465S, RSH600324S, RSH600531S, RSH600385S, RSH600242S, RSH600561S, RSH600547S, RSH600599S, RSH600546S, RSH600838S, RSH600807S, RSH600813S, RSH600615S, RSH601017S, RSH601005S, RSH600957S, RSH600868S, RSH600459S, RSH600217S, RSH600607S, RSH600551S, RSH600668S, RSH600545S, RSH600896S, RSH600697S, RSH600853S, RSH600852S, RSH600696S, RSH600931S, RSH600690S, RSH600944S, RSH600937S, RSH600933S, RSH600233S, RSH600035S, RSH600354S, RSH600455S, RSH600738S, RSH600729S, RSH600428S, RSH600786S, RSH600840S, RSH600500S, RSH600402S, RSH600916S, RSH600834S, RSH600025S, RSH600566S, RSH601015S, RSH600622S, RSH600540S, RSH600214S, RSH600568S, RSH600784S, RSH600627S, RSH600890S, RSH600953S, RSH600877S, RSH600859S, RSH601048S, RSH601043S, RSH601012S, RSH600958S, RSH600947S, RSH600909S, RSH600888S, RSH600886S, RSH600883S, RSH601042S, RSH601016S, RSH600247S, RSH600246S, RSH600034S, RSH600248S, RSH600272S, RSH600362S, RSH600368S, RSH600376S, RSH600489S, RSH600390S, RSH600379S, RSH600371S, RSH600363S, RSH600212S, RSH600464S, RSH600457S, RSH600458S, RSH600535S, RSH600451S, RSH600541S, RSH600536S, RSH600400S, RSH600532S, RSH600529S, RSH600618S, RSH600616S, RSH600462S, RSH600732S, RSH600761S, RSH600759S, RSH600663S, RSH600590S, RSH600785S, RSH600862S, RSH600625S, RSH600869S, RSH600874S, RSH600904S, RSH600892S, RSH601053S, RSH600670S, RSH601040S, RSH600850S, RSH600791S, RSH600952S, RSH600938S, RSH600563S, RSH600505S, RSH600954S, RSH600580S, RSH600894S, RSH600837S, RSH600017S, RSH600020S, RSH600016S, RSH600237S, RSH600185S, RSH600409S, RSH600410S, RSH600699S, RSH600624S, RSH600582S, RSH600496S, RSH600660S, RSH600559S, RSH600613S, RSH600836S, RSH600878S, RSH600461S, RSH600873S, RSH600918S, RSH600504S, RSH600501S, RSH600876S, RSH600780S, RSH600848S, RSH601055S, RSH600244S, RSH600552S, RSH600384S, RSH600600S, RSH600567S, RSH600811S, RSH600941S, RSH600939S, RSH600502S, RSH600915S, RSH601010S, RSH600914S, RSH600254S, RSH600271S, RSH600484S, RSH600482S, RSH600485S, RSH600483S, RSH600477S, RSH600509S, RSH600507S, RSH600493S, RSH600494S, RSH600478S, RSH600747S, RSH600745S, RSH600744S, RSH600741S, RSH600740S, RSH600739S, RSH600737S, RSH600736S, RSH600735S, RSH600734S, RSH600481S, RSH600471S, RSH600473S, RSH600476S, RSH600474S, RSH600491S, RSH600719S, RSH600475S, RSH600472S, RSH600731S, RSH600479S, RSH600769S, RSH600720S, RSH600727S, RSH600490S, RSH600984S, RSH600724S, RSH600986S, RSH600981S, RSH600718S, RSH600765S, RSH600684S, RSH600777S, RSH600681S, RSH601054S, RSH600963S, RSH600998S, RSH600733S, RSH600973S, RSH600997S, RSH600972S, RSH600677S, RSH601044S, RSH600470S, RSH600706S, RSH600705S, RSH600704S, RSH600703S, RSH600969S, RSH600702S, RSH600700S, RSH601050S, RSH601047S, RSH601001S, RSH600701S, RSH600693S, RSH601069S, RSH600695S, RSH600686S, RSH600994S, RSH600688S, RSH600985S, RSH601002S, RSH600687S, RSH601046S, RSH600754S, RSH601045S, RSH600755S, RSH600752S, RSH600756S, RSH600717S, RSH600757S, RSH600749S, RSH600992S, RSH600989S, RSH600990S, RSH600991S, RSH600965S, RSH600967S, RSH600751S, RSH600748S, RSH600987S, RSH600767S, RSH600760S, RSH600768S, RSH600976S, RSH600980S, RSH601013S, RSH600678S, RSH600715S, RSH600469S, RSH600486S, RSH600679S, RSH600680S, RSH601008S, RSH600970S, RSH600774S, RSH601011S, RSH601067S, RSH600961S, RSH600707S, RSH600955S, RSH600926S, RSH600604S, RSH600595S, RSH600570S, RSH600614S, RSH600588S, RSH600439S, RSH600433S, RSH600646S, RSH600637S, RSH600644S, RSH600788S, RSH600634S, RSH600636S, RSH600631S, RSH600682S, RSH600683S, RSH600672S, RSH600799S, RSH600893S, RSH600835S, RSH600885S, RSH600867S, RSH600900S, RSH600783S, RSH600499S, RSH600630S, RSH600841S, RSH600866S, RSH600945S, RSH600872S, RSH600897S, RSH600946S, RSH600778S, RSH600792S, RSH600809S, RSH600843S, RSH600845S, RSH600856S, RSH600555S, RSH600798S, RSH600860S, RSH601019S, RSH600875S, RSH601006S, RSH600575S, RSH600746S, RSH600750S, RSH600431S, RSH600652S, RSH600576S, RSH600380S, RSH600966S, RSH600776S, RSH600772S, RSH600775S, RSH600884S, RSH601003S, RSH601059S, RSH601056S, RSH600977S, RSH600964S, RSH601020S, RSH600708S, RSH600971S, RSH600988S, RSH600764S, RSH600713S, RSH600711S, RSH600716S, RSH600549S, RSH600956S, RSH600805S, RSH600709S, RSH600405S, RSH600389S, RSH600794S, RSH600544S, RSH600803S, RSH600556S, RSH600206S, RSH600243S, RSH600399S, RSH600226S, RSH600009S, RSH600487S, RSH600728S, RSH600730S, RSH600468S, RSH600488S, RSH600789S, RSH600810S, RSH600620S, RSH600460S, RSH600898S, RSH600498S, RSH600870S, RSH600623S, RSH600609S, RSH600539S, RSH600533S, RSH600411S, RSH600213S, RSH600029S, RSH600015S, RSH600008S, RSH600447S, RSH600508S, RSH600725S, RSH600999S, RSH601000S, RSH600429S, RSH600438S, RSH600771S, RSH600982S, RSH600480S, RSH600770S, RSH600019S, RSH600018S, RSH600846S, RSH600844S, RSH601049S, RSH600847S, RSH601066S, RSH600495S, RSH600781S, RSH600594S, RSH600593S, RSH600435S, RSH600571S, RSH600424S, RSH600443S, RSH600256S, RSH600603S, RSH600432S, RSH600579S, RSH600425S, RSH600255S, RSH600569S, RSH600577S, RSH600578S, RSH600573S, RSH600421S, RSH600598S, RSH600446S, RSH600450S, RSH600440S, RSH600448S, RSH600420S, RSH600269S, RSH600927S, RSH600928S, RSH600949S, RSH600974S, RSH600978S, RSH600925S, RSH600437S, RSH600434S, RSH600445S, RSH600436S, RSH600423S, RSH600449S, RSH600252S, RSH600422S, RSH600612S, RSH600441S, RSH600444S, RSH600608S, RSH600581S, RSH600591S, RSH600605S, RSH600597S, RSH600592S, RSH600565S, RSH600669S, RSH601007S, RSH600940S, RSH600665S, RSH600943S, RSH600880S, RSH600905S, RSH600855S, RSH600779S, RSH600808S, RSH600602S, RSH600851S, RSH600626S, RSH600629S, RSH600467S, RSH600587S, RSH600209S, RSH600585S, RSH600562S, RSH600381S, RSH600466S, RSH600395S, RSH600397S, RSH600863S, RSH600796S, RSH600550S, RSH600558S, RSH600662S, RSH600403S, RSH600560S; b) Crome DR: DDPC3D1, DDPC3D4; Model DDPC3D1: GTIN 00763000178413, Serial Numbers: RSP600249S, RSP600057S, RSP600253S, RSP600085S, RSP600386S, RSP600014S, RSP600075S, RSP600150S, RSP600148S, RSP600089S, RSP600091S, RSP600114S, RSP600189S, RSP600210S, RSP600394S, RSP600273S, RSP600130S, RSP600216S, RSP600256S, RSP600245S, RSP600149S, RSP600068S, RSP600069S, RSP600066S, RSP600083S, RSP600112S, RSP600132S, RSP600404S, RSP600136S, RSP600076S, RSP600096S, RSP600224S, RSP600211S, RSP600209S, RSP600154S, RSP600392S, RSP600267S, RSP600060S, RSP600104S, RSP600163S, RSP600152S, RSP600276S, RSP600250S, RSP600187S, RSP600203S, RSP600221S, RSP600217S, RSP600230S, RSP600398S, RSP600190S, RSP600079S, RSP600219S, RSP600059S, RSP600372S, RSP600346S, RSP600065S, RSP600095S, RSP600049S, RSP600145S, RSP600070S, RSP600200S, RSP600226S, RSP600138S, RSP600157S, RSP600202S, RSP600413S, RSP600360S, RSP600395S, RSP600180S, RSP600193S, RSP600246S, RSP600139S, RSP600082S, RSP600288S, RSP600218S, RSP600141S, RSP600400S, RSP600335S, RSP600383S, RSP600544S, RSP600408S, RSP600444S, RSP600363S, RSP600080S, RSP600322S, RSP600396S, RSP600397S, RSP600048S, RSP600369S, RSP600204S, RSP600074S; GTIN 00763000178420, Serial Numbers: RSP600155S, RSP600100S, RSP600517S, RSP600523S, RSP600639S, RSP600575S, RSP600614S, RSP600521S, RSP600609S, RSP600650S, RSP600616S, RSP600513S, RSP600151S, RSP600649S, RSP600641S, RSP600651S, RSP600520S, RSP600179S, RSP600594S, RSP600524S, RSP600143S, RSP600064S, RSP600061S, RSP600056S, RSP600172S, RSP600171S, RSP600554S, RSP600543S, RSP600634S, RSP600633S, RSP600516S, RSP600615S, RSP600579S, RSP600561S, RSP600027S, RSP600563S, RSP600591S, RSP600041S, RSP600034S, RSP600595S, RSP600596S, RSP600536S, RSP600538S, RSP600564S, RSP600508S, RSP600522S, RSP600525S, RSP600526S, RSP600510S, RSP600662S, RSP600511S, RSP600528S, RSP600515S, RSP600643S, RSP600642S, RSP600644S, RSP600624S, RSP600625S, RSP600622S, RSP600657S, RSP600623S, RSP600621S, RSP600557S, RSP600588S, RSP600556S, RSP600655S, RSP600592S, RSP600553S, RSP600555S, RSP600626S, RSP600547S, RSP600414S, RSP600665S, RSP600669S, RSP600668S, RSP600664S, RSP600659S, RSP600666S, RSP600550S, RSP600533S, RSP600542S, RSP600667S, RSP600552S, RSP600551S, RSP600519S, RSP600646S, RSP600571S, RSP600568S, RSP600576S, RSP600581S, RSP600585S, RSP600567S, RSP600586S, RSP600589S, RSP600573S, RSP600653S, RSP600539S, RSP600541S, RSP600559S, RSP600630S, RSP600635S, RSP600636S, RSP600618S, RSP600632S, RSP600582S, RSP600565S, RSP600638S, RSP600562S, RSP600577S, RSP600640S, RSP600619S, RSP600627S, RSP600628S, RSP600570S, RSP600670S, RSP600560S, RSP600661S, RSP600620S, RSP600604S, RSP600601S, RSP600600S, RSP600603S, RSP600599S, RSP600598S, RSP600597S, RSP600675S, RSP600660S, RSP600672S, RSP600673S, RSP600546S, RSP600656S, RSP600663S, RSP600658S, RSP600674S, RSP600612S, RSP600613S, RSP600607S, RSP600606S, RSP600610S, RSP600671S, RSP600574S, RSP600549S, RSP600512S, RSP600531S, RSP600617S, RSP600125S, RSP600537S, RSP600540S, RSP600077S, RSP600593S, RSP600590S, RSP600401S, RSP600165S; Model DDPC3D4: GTIN 00763000178437, Serial Numbers: RSQ600736S, RSQ600745S, RSQ600905S, RSQ600975S, RSQ600115S, RSQ600114S, RSQ600113S, RSQ600261S, RSQ600258S, RSQ600257S, RSQ600256S, RSQ600255S, RSQ600740S, RSQ601137S, RSQ601122S, RSQ600996S, RSQ601103S, RSQ600142S, RSQ600055S, RSQ600163S, RSQ600164S, RSQ600936S, RSQ600916S, RSQ601138S, RSQ601108S, RSQ600952S, RSQ600049S, RSQ600051S, RSQ600713S, RSQ600777S, RSQ600991S, RSQ600814S, RSQ600627S, RSQ600831S, RSQ600218S, RSQ600755S, RSQ600783S, RSQ600679S, RSQ600723S, RSQ600772S, RSQ600237S, RSQ600074S, RSQ600913S, RSQ600820S, RSQ600801S, RSQ600685S, RSQ600858S, RSQ600090S, RSQ600712S, RSQ600931S, RSQ600053S, RSQ600012S, RSQ600633S, RSQ600811S, RSQ600843S, RSQ600912S, RSQ600935S, RSQ600894S, RSQ600754S, RSQ600195S, RSQ600748S, RSQ600782S, RSQ600665S, RSQ600105S, RSQ600091S, RSQ600106S, RSQ600130S, RSQ600183S, RSQ600185S, RSQ600216S, RSQ600174S, RSQ600799S, RSQ600767S, RSQ600788S, RSQ600743S, RSQ600773S, RSQ600704S, RSQ600808S, RSQ600262S, RSQ600101S, RSQ600738S, RSQ600678S, RSQ600140S, RSQ600093S, RSQ600737S, RSQ600750S, RSQ600753S, RSQ600789S, RSQ600694S, RSQ600125S, RSQ600744S, RSQ600128S, RSQ600807S, RSQ600829S, RSQ600906S, RSQ600780S, RSQ600233S, RSQ600751S, RSQ600097S, RSQ600247S, RSQ600752S, RSQ600821S, RSQ600719S, RSQ600705S, RSQ600119S, RSQ600149S, RSQ600150S, RSQ600109S, RSQ600059S, RSQ600110S, RSQ600721S, RSQ600897S, RSQ600812S, RSQ600915S, RSQ600859S, RSQ600986S, RSQ600989S, RSQ600939S, RSQ600896S, RSQ600232S, RSQ600790S, RSQ600787S, RSQ600938S, RSQ600842S, RSQ600071S, RSQ600191S, RSQ600078S, RSQ600231S, RSQ601010S, RSQ600225S, RSQ600742S, RSQ600759S, RSQ600800S, RSQ600084S, RSQ600139S, RSQ600786S, RSQ601134S, RSQ600092S, RSQ600111S, RSQ600205S, RSQ600924S, RSQ600921S, RSQ600165S, RSQ600771S, RSQ600984S, RSQ600982S, RSQ600201S, RSQ600726S, RSQ600900S, RSQ600951S, RSQ600907S, RSQ600226S, RSQ600186S, RSQ600157S, RSQ600135S, RSQ600098S, RSQ600993S, RSQ601000S, RSQ600970S, RSQ600917S, RSQ600895S, RSQ600252S, RSQ601008S, RSQ600253S, RSQ600220S, RSQ600073S, RSQ600061S, RSQ600809S, RSQ600141S, RSQ600243S, RSQ600085S, RSQ600080S, RSQ601147S, RSQ600794S, RSQ600648S, RSQ600700S, RSQ600911S, RSQ600083S, RSQ600971S, RSQ600934S, RSQ600958S, RSQ600710S, RSQ600054S, RSQ600143S, RSQ600184S, RSQ600076S, RSQ600067S, RSQ600058S, RSQ600148S, RSQ600131S, RSQ600066S, RSQ600259S, RSQ600677S, RSQ600207S, RSQ600171S, RSQ600112S, RSQ600248S, RSQ600244S, RSQ600254S, RSQ600823S, RSQ600781S, RSQ600221S, RSQ600108S, RSQ600194S, RSQ600460S, RSQ600246S, RSQ600241S, RSQ600236S, RSQ600836S, RSQ600813S, RSQ600156S, RSQ600065S, RSQ600122S, RSQ600796S, RSQ600127S, RSQ600154S, RSQ600929S, RSQ601001S, RSQ600959S, RSQ600774S, RSQ600960S, RSQ600927S, RSQ600768S, RSQ600987S, RSQ600691S, RSQ600123S, RSQ600607S, RSQ600668S, RSQ600120S, RSQ600212S, RSQ600728S, RSQ600094S, RSQ600675S, RSQ600242S, RSQ600056S, RSQ600137S, RSQ600136S, RSQ600152S, RSQ600133S, RSQ600166S, RSQ600147S, RSQ600210S, RSQ600082S, RSQ600146S, RSQ600129S, RSQ600159S, RSQ600666S, RSQ600197S, RSQ600928S, RSQ600079S, RSQ600266S, RSQ600204S, RSQ600202S, RSQ600667S, RSQ600776S, RSQ600990S, RSQ600224S, RSQ600134S, RSQ600739S, RSQ600827S, RSQ600941S, RSQ600057S, RSQ600747S, RSQ600670S, RSQ600957S, RSQ600778S, RSQ600910S, RSQ600791S, RSQ600070S, RSQ600167S, RSQ600153S, RSQ600175S, RSQ600263S, RSQ600798S, RSQ600998S, RSQ600824S, RSQ600802S, RSQ600089S, RSQ600919S, RSQ600828S, RSQ600985S, RSQ600904S, RSQ600793S, RSQ601148S, RSQ601002S, RSQ600973S, RSQ600899S, RSQ600903S, RSQ600983S, RSQ600804S, RSQ600803S, RSQ600816S, RSQ600785S, RSQ601110S, RSQ600837S, RSQ601132S, RSQ600944S, RSQ600923S, RSQ600930S, RSQ600995S, RSQ600988S, RSQ600992S, RSQ600822S, RSQ600717S, RSQ600169S, RSQ600716S, RSQ600769S, RSQ600779S, RSQ600081S, RSQ600068S, RSQ600118S, RSQ600860S, RSQ600890S, RSQ600610S, RSQ600817S, RSQ600974S, RSQ600966S, RSQ601006S, RSQ600830S, RSQ600908S, RSQ600968S, RSQ600765S, RSQ600972S, RSQ600979S, RSQ600920S, RSQ600733S, RSQ600762S, RSQ600240S, RSQ600943S, RSQ600693S, RSQ600734S, RSQ600758S, RSQ600698S, RSQ600766S, RSQ600757S, RSQ600641S, RSQ600761S, RSQ600775S, RSQ600657S, RSQ600162S, RSQ600181S, RSQ600683S, RSQ600749S, RSQ600764S, RSQ600741S, RSQ600177S, RSQ600178S, RSQ600213S, RSQ600222S, RSQ600179S, RSQ600209S, RSQ600227S, RSQ600228S, RSQ600760S, RSQ600718S, RSQ600695S, RSQ600075S, RSQ600854S, RSQ600815S, RSQ600940S, RSQ600160S, RSQ600701S, RSQ600763S, RSQ600746S, RSQ600223S, RSQ600155S, RSQ600102S, RSQ600948S, RSQ600918S, RSQ600922S, RSQ600703S, RSQ600709S, RSQ600978S, RSQ600702S; GTIN 00763000178444, Serial Numbers: RSQ600459S, RSQ600290S, RSQ600435S, RSQ601093S, RSQ600582S, RSQ600593S, RSQ600489S, RSQ600024S, RSQ600494S, RSQ601032S, RSQ601029S, RSQ600554S, RSQ600047S, RSQ600042S, RSQ600027S, RSQ600031S, RSQ600585S, RSQ601042S, RSQ601081S, RSQ600550S, RSQ600926S, RSQ601085S, RSQ600620S, RSQ600655S, RSQ600618S, RSQ600650S, RSQ600643S, RSQ600647S, RSQ600640S, RSQ601009S, RSQ601077S, RSQ600845S, RSQ600832S, RSQ600708S, RSQ600605S, RSQ600530S, RSQ600652S, RSQ601091S, RSQ600046S, RSQ600032S, RSQ600806S, RSQ600727S, RSQ600725S, RSQ600395S, RSQ600635S, RSQ600557S, RSQ600560S, RSQ600847S, RSQ600562S, RSQ600528S, RSQ600190S, RSQ601041S, RSQ601048S, RSQ601046S, RSQ601058S, RSQ600022S, RSQ600851S, RSQ600626S, RSQ600294S, RSQ601011S, RSQ601127S, RSQ601057S, RSQ600953S, RSQ600825S, RSQ601055S, RSQ600472S, RSQ600439S, RSQ601053S, RSQ600792S, RSQ600687S, RSQ601040S, RSQ601082S, RSQ601021S, RSQ600449S, RSQ600446S, RSQ600445S, RSQ600444S, RSQ600443S, RSQ600437S, RSQ600805S, RSQ600639S, RSQ600438S, RSQ600295S, RSQ600676S, RSQ601052S, RSQ601067S, RSQ600464S, RSQ600561S, RSQ600592S, RSQ600622S, RSQ600722S, RSQ600531S, RSQ600955S, RSQ601024S, RSQ600835S, RSQ600674S, RSQ600878S, RSQ601016S, RSQ600553S, RSQ601114S, RSQ601107S, RSQ600552S, RSQ600485S, RSQ600462S, RSQ600663S, RSQ600662S, RSQ600863S, RSQ600866S, RSQ600962S, RSQ600690S, RSQ600784S, RSQ600287S, RSQ601017S, RSQ600873S, RSQ601018S, RSQ601062S, RSQ601036S, RSQ600281S, RSQ600586S, RSQ600567S, RSQ600382S, RSQ600381S, RSQ600628S, RSQ600604S, RSQ600671S, RSQ600664S, RSQ600297S, RSQ600466S, RSQ600467S, RSQ600965S, RSQ600964S, RSQ601080S, RSQ601079S, RSQ600688S, RSQ600686S, RSQ601088S, RSQ600532S, RSQ600535S, RSQ600608S, RSQ600453S, RSQ600706S, RSQ600230S, RSQ600587S, RSQ600013S, RSQ600011S, RSQ600711S, RSQ600260S, RSQ600206S, RSQ600434S, RSQ600215S, RSQ600730S, RSQ600217S, RSQ600872S, RSQ600366S, RSQ600365S, RSQ600007S, RSQ600015S, RSQ600014S, RSQ600009S, RSQ600383S, RSQ600387S, RSQ600518S, RSQ600512S, RSQ600488S, RSQ600853S, RSQ600880S, RSQ600882S, RSQ600888S, RSQ600579S, RSQ600889S, RSQ600006S, RSQ600475S, RSQ600018S, RSQ600487S, RSQ600578S, RSQ600590S, RSQ600864S, RSQ601126S, RSQ600865S, RSQ600551S, RSQ600519S, RSQ600008S, RSQ600023S, RSQ600893S, RSQ600714S, RSQ600588S, RSQ600696S, RSQ600697S, RSQ600856S, RSQ600862S, RSQ601098S, RSQ600468S, RSQ600189S, RSQ600892S, RSQ600473S, RSQ600044S, RSQ600250S, RSQ600193S, RSQ600340S, RSQ600615S, RSQ600603S, RSQ600441S, RSQ600045S, RSQ600516S, RSQ600514S, RSQ601025S, RSQ600599S, RSQ601074S, RSQ601076S, RSQ600563S, RSQ600564S, RSQ600517S, RSQ600414S, RSQ600413S, RSQ600393S, RSQ600403S, RSQ600404S, RSQ600398S, RSQ600397S, RSQ600407S, RSQ600386S, RSQ600504S, RSQ600503S, RSQ600399S, RSQ600400S, RSQ600440S, RSQ600401S, RSQ600442S, RSQ600412S, RSQ600396S, RSQ600486S, RSQ600555S, RSQ600527S, RSQ601059S, RSQ600515S, RSQ600402S, RSQ601145S, RSQ601117S, RSQ601106S, RSQ601144S, RSQ600469S, RSQ601133S, RSQ601128S, RSQ600406S, RSQ600405S, RSQ601121S, RSQ600583S, RSQ600521S, RSQ600498S, RSQ601020S, RSQ600522S, RSQ600448S, RSQ600616S, RSQ601047S, RSQ601115S, RSQ600409S, RSQ600684S, RSQ600999S, RSQ600909S, RSQ601023S, RSQ600625S, RSQ601140S, RSQ600632S, RSQ600629S, RSQ600638S, RSQ600630S, RSQ600636S, RSQ600623S, RSQ600617S, RSQ601054S, RSQ601109S, RSQ600619S, RSQ601130S, RSQ600452S, RSQ600450S, RSQ600680S, RSQ600455S, RSQ600642S, RSQ600463S, RSQ600451S, RSQ601005S, RSQ600644S, RSQ600689S, RSQ601027S, RSQ601035S, RSQ601142S, RSQ601003S, RSQ601060S, RSQ601050S, RSQ601118S, RSQ601136S, RSQ601102S, RSQ601125S, RSQ601051S, RSQ600474S, RSQ600456S, RSQ600370S, RSQ600373S, RSQ600411S, RSQ600371S, RSQ600447S, RSQ600379S, RSQ601141S, RSQ601030S, RSQ601124S, RSQ601139S, RSQ600613S, RSQ600612S, RSQ601131S, RSQ600614S, RSQ601113S, RSQ600372S, RSQ600669S, RSQ600672S, RSQ600408S, RSQ600520S, RSQ600653S, RSQ601146S, RSQ601013S, RSQ600963S, RSQ600631S, RSQ600950S, RSQ600533S, RSQ600540S, RSQ600542S, RSQ600870S, RSQ600510S, RSQ601084S, RSQ601012S, RSQ601068S, RSQ601089S, RSQ601087S, RSQ601071S, RSQ601072S, RSQ600886S, RSQ600589S, RSQ601083S, RSQ600575S, RSQ600834S, RSQ601061S, RSQ600881S, RSQ600850S, RSQ600556S, RSQ600581S, RSQ600559S, RSQ600558S, RSQ600871S, RSQ600826S, RSQ600857S, RSQ600513S, RSQ600846S, RSQ600577S, RSQ600600S, RSQ600841S, RSQ600849S, RSQ600597S, RSQ600598S, RSQ600492S, RSQ600844S, RSQ600574S, RSQ600819S, RSQ600855S, RSQ600707S, RSQ600848S, RSQ600838S, RSQ600833S, RSQ601095S, RSQ600852S, RSQ600839S, RSQ600867S, RSQ601033S, RSQ601043S, RSQ601019S, RSQ600925S, RSQ600637S, RSQ600868S, RSQ601044S, RSQ600594S, RSQ600861S, RSQ600019S, RSQ600264S, RSQ601104S, RSQ601116S, RSQ601112S, RSQ601123S, RSQ601105S, RSQ601129S, RSQ600461S, RSQ600458S, RSQ601031S, RSQ601049S, RSQ601056S, RSQ600901S, RSQ600534S, RSQ600902S, RSQ600523S, RSQ600480S, RSQ600479S, RSQ600609S, RSQ600673S, RSQ600477S, RSQ600476S, RSQ600525S, RSQ600565S, RSQ600596S, RSQ600580S, RSQ601066S, RSQ600884S, RSQ600883S, RSQ600484S, RSQ601022S, RSQ600394S, RSQ600037S, RSQ601149S, RSQ601143S, RSQ601037S, RSQ601034S, RSQ600661S, RSQ600654S, RSQ600646S, RSQ600649S, RSQ600659S, RSQ601038S, RSQ600572S, RSQ601069S, RSQ600471S, RSQ601045S, RSQ600840S, RSQ600624S, RSQ600869S, RSQ600651S, RSQ600030S, RSQ600879S, RSQ600731S, RSQ600020S, RSQ600410S, RSQ600681S, RSQ600482S, RSQ600380S, RSQ600501S, RSQ600385S, RSQ600384S, RSQ601064S, RSQ600198S, RSQ600040S, RSQ600529S, RSQ600470S, RSQ600433S, RSQ600511S, RSQ600490S, RSQ600010S, RSQ600524S, RSQ600039S, RSQ600038S, RSQ600682S, RSQ600367S, RSQ600898S, RSQ601111S, RSQ600692S, RSQ600584S, RSQ600378S, RSQ600368S, RSQ601065S, RSQ600887S, RSQ600715S, RSQ600034S, RSQ600491S, RSQ600507S, RSQ600549S, RSQ601120S, RSQ601070S, RSQ600505S, RSQ600506S, RSQ600496S, RSQ600493S, RSQ600545S, RSQ601039S, RSQ600546S, RSQ600537S, RSQ600538S, RSQ600536S, RSQ600818S, RSQ601100S, RSQ600483S, RSQ600377S, RSQ600369S, RSQ600376S, RSQ600364S, RSQ600497S, RSQ600543S, RSQ600874S, RSQ600495S, RSQ600499S, RSQ600947S, RSQ600508S, RSQ600548S, RSQ600391S, RSQ600509S, RSQ600041S, RSQ600810S, RSQ600388S, RSQ600390S, RSQ600234S, RSQ600187S, RSQ600203S, RSQ600541S, RSQ600699S, RSQ600724S, RSQ601075S, RSQ600196S, RSQ601119S, RSQ600544S, RSQ600500S, RSQ600502S, RSQ600539S, RSQ600547S, RSQ601099S, RSQ600392S, RSQ600956S, RSQ600961S, RSQ600967S, RSQ600875S, RSQ600876S, RSQ600634S, RSQ600457S, RSQ600526S, RSQ600454S, RSQ600026S; c) Crome HF: DTPC2D4, DTPC2D1; Model DTPC2D4: GTIN 00763000178291, Serial Numbers: RTW600307S, RTW600091S, RTW600313S, RTW600328S, RTW600121S, RTW600342S, RTW600074S, RTW600144S, RTW600102S, RTW600319S, RTW600346S, RTW600277S, RTW600309S, RTW600099S, RTW600098S, RTW600133S, RTW600118S, RTW600168S, RTW600205S, RTW600159S, RTW600119S, RTW600123S, RTW600138S, RTW600067S, RTW600217S, RTW600333S, RTW600052S, RTW600169S, RTW600059S, RTW600229S, RTW600196S, RTW600104S, RTW600116S, RTW600101S, RTW600151S, RTW600304S, RTW600306S, RTW600223S, RTW600062S, RTW600343S, RTW600114S, RTW600171S, RTW600057S, RTW600049S, RTW600126S, RTW600130S, RTW600158S, RTW600163S, RTW600181S, RTW600188S, RTW600153S, RTW600211S, RTW600204S, RTW600182S, RTW600240S, RTW600230S, RTW600247S, RTW600245S, RTW600250S, RTW600249S, RTW600317S, RTW600178S, RTW600323S, RTW600338S, RTW600254S, RTW600195S, RTW600097S, RTW600129S, RTW600154S, RTW600339S, RTW600164S, RTW600048S, RTW600213S, RTW600187S, RTW600165S, RTW600143S, RTW600315S, RTW600073S, RTW600172S, RTW600332S, RTW600085S, RTW600228S, RTW600175S, RTW600113S, RTW600308S, RTW600109S, RTW600200S, RTW600147S, RTW600065S, RTW600136S, RTW600053S, RTW600244S, RTW600125S, RTW600160S, RTW600120S, RTW600008S, RTW600051S, RTW600056S, RTW600089S, RTW600111S, RTW600330S, RTW600331S, RTW600071S, RTW600183S, RTW600292S, RTW600347S, RTW600350S, RTW600363S, RTW600365S, RTW600358S, RTW600362S, RTW600139S, RTW600082S, RTW600087S, RTW600090S, RTW600054S, RTW600075S, RTW600239S, RTW600297S, RTW600354S, RTW600149S, RTW600345S, RTW600110S, RTW600068S, RTW600237S, RTW600069S, RTW600148S, RTW600080S, RTW600156S, RTW600127S, RTW600161S, RTW600094S, RTW600179S; GTIN 00763000178314, Serial Numbers; RTW600405S, RTW600413S, RTW600496S, RTW600404S, RTW600494S, RTW600497S, RTW600335S, RTW600486S, RTW600500S, RTW600038S, RTW600321S, RTW600410S, RTW600510S, RTW600397S, RTW600441S, RTW600415S, RTW600492S, RTW600456S, RTW600512S, RTW600316S, RTW600340S, RTW600022S, RTW600465S, RTW600412S, RTW600393S, RTW600318S, RTW600336S, RTW600469S, RTW600388S, RTW600334S, RTW600470S, RTW600509S, RTW600487S, RTW600502S, RTW600408S, RTW600495S, RTW600467S, RTW600466S, RTW600232S, RTW600392S, RTW600395S, RTW600032S, RTW600361S, RTW600421S, RTW600433S, RTW600436S, RTW600400S, RTW600341S, RTW600387S, RTW600419S, RTW600461S, RTW600394S, RTW600463S, RTW600364S, RTW600508S, RTW600420S, RTW600398S, RTW600389S, RTW600403S, RTW600417S, RTW600399S, RTW600040S, RTW600041S, RTW600045S, RTW600479S, RTW600478S, RTW600474S, RTW600344S, RTW600507S, RTW600324S, RTW600422S, RTW600453S, RTW600454S, RTW600425S, RTW600426S, RTW600459S, RTW600511S, RTW600450S, RTW600437S, RTW600443S, RTW600457S, RTW600476S, RTW600460S, RTW600447S, RTW600448S, RTW600455S, RTW600449S, RTW600452S, RTW600506S, RTW600503S, RTW600493S, RTW600481S, RTW600462S, RTW600458S, RTW600488S, RTW600501S, RTW600475S, RTW600468S, RTW600464S, RTW600483S, RTW600473S, RTW600490S, RTW600414S, RTW600505S, RTW600428S, RTW600427S, RTW600430S, RTW600401S, RTW600391S, RTW600489S, RTW600311S, RTW600386S, RTW600451S, RTW600482S, RTW600390S, RTW600356S, RTW600029S, RTW600028S, RTW600027S, RTW600444S, RTW600445S, RTW600351S, RTW600025S, RTW600033S, RTW600396S, RTW600018S, RTW600359S, RTW600034S, RTW600360S, RTW600471S, RTW600498S, RTW600020S; Model DTPC2D1: GTIN 00763000178307, Serial Numbers: RTX600084S, RTX600076S, RTX600148S, RTX600139S, RTX600586S, RTX600587S, RTX600594S, RTX600584S, RTX600114S, RTX600142S, RTX600597S, RTX600308S, RTX600386S, RTX600327S, RTX600334S, RTX600372S, RTX600048S, RTX600066S, RTX600108S, RTX600261S, RTX600046S, RTX600345S, RTX600382S, RTX600593S, RTX600388S, RTX600096S, RTX600069S, RTX600064S, RTX600377S, RTX600360S, RTX600581S, RTX600158S, RTX600306S, RTX600117S, RTX600100S, RTX600319S, RTX600045S, RTX600153S, RTX600157S, RTX600326S, RTX600081S, RTX600146S, RTX600058S, RTX600055S, RTX600314S, RTX600332S, RTX600323S, RTX600143S, RTX600344S, RTX600385S, RTX600307S, RTX600310S, RTX600317S, RTX600588S, RTX600063S, RTX600072S, RTX600095S, RTX600050S, RTX600147S, RTX600075S, RTX600399S, RTX600582S, RTX600400S, RTX600169S, RTX600309S, RTX600329S, RTX600305S, RTX600167S, RTX600054S, RTX600131S, RTX600580S, RTX600381S, RTX600335S, RTX600082S, RTX600340S, RTX600080S, RTX600077S, RTX600053S, RTX600380S, RTX600393S, RTX600371S, RTX600331S, RTX600585S, RTX600595S, RTX600349S, RTX600047S, RTX600395S, RTX600396S, RTX600389S, RTX600392S, RTX600375S, RTX600376S, RTX600342S, RTX600358S, RTX600341S, RTX600086S, RTX600322S, RTX600343S, RTX600365S, RTX600583S, RTX600121S, RTX600091S, RTX600106S, RTX600320S, RTX

Quantity Affected: 3944 units

Reason for Recall

Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

Type: Voluntary: Firm initiated

Recall Initiated: 2022-04-12

Company