Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model

Summary

The FDA issued a Class I for Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization The by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Reason: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardiove.

Details

Product Description

Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1

Lot/Code Info: a. Model Numbers: DTPC2D4: GTIN 00763000178291, Serial Numbers: RTW600120S, RTW600307S; GTIN 00763000178314, Serial Numbers: RTW600018S, RTW600020S, RTW600022S, RTW600025S, RTW600027S, RTW600028S, RTW600029S, RTW600032S, RTW600033S, RTW600034S, RTW600038S, RTW600040S, RTW600041S, RTW600045S, RTW600232S, RTW600316S, RTW600318S, RTW600321S, RTW600324S, RTW600334S, RTW600335S, RTW600336S, RTW600340S, RTW600341S, RTW600344S, RTW600351S, RTW600356S, RTW600359S, RTW600360S, RTW600361S, RTW600364S, RTW600387S, RTW600388S, RTW600389S, RTW600390S, RTW600391S, RTW600392S, RTW600393S, RTW600394S, RTW600395S, RTW600396S, RTW600397S, RTW600398S, RTW600399S, RTW600400S, RTW600401S, RTW600403S, RTW600404S, RTW600405S, RTW600408S, RTW600410S, RTW600412S, RTW600413S, RTW600415S, RTW600417S, RTW600419S, RTW600420S, RTW600421S, RTW600422S, RTW600425S, RTW600426S, RTW600427S, RTW600428S, RTW600430S, RTW600433S, RTW600436S, RTW600441S, RTW600444S, RTW600445S, RTW600449S, RTW600450S, RTW600452S, RTW600453S, RTW600454S, RTW600456S, RTW600459S, RTW600461S, RTW600463S, RTW600465S, RTW600466S, RTW600467S, RTW600468S, RTW600469S, RTW600470S, RTW600471S, RTW600474S, RTW600476S, RTW600478S, RTW600479S, RTW600481S, RTW600482S, RTW600486S, RTW600487S, RTW600488S, RTW600489S, RTW600490S, RTW600492S, RTW600493S, RTW600494S, RTW600495S, RTW600496S, RTW600497S, RTW600498S, RTW600500S, RTW600501S, RTW600502S, RTW600503S, RTW600505S, RTW600506S, RTW600507S, RTW600508S, RTW600509S, RTW600510S, RTW600511S, RTW600512S, RTW600513S, RTW600514S, RTW600515S, RTW600516S, RTW600517S, RTW600518S, RTW600519S, RTW600520S, RTW600521S, RTW600522S, RTW600523S, RTW600529S, RTW600533S, RTW600534S, RTW600536S, RTW600538S, RTW600541S, RTW600544S, RTW600545S, RTW600546S, RTW600549S, RTW600554S; DTPC2D1: GTIN 00763000178307, Serial Numbers: RTX600387S, RTX600584S, RTX600586S, RTX600587S, RTX600597S; GTIN 00763000178321, Serial Numbers: RTX600014S, RTX600015S, RTX600016S, RTX600018S, RTX600022S, RTX600025S, RTX600027S, RTX600028S, RTX600029S, RTX600030S, RTX600034S, RTX600035S, RTX600088S, RTX600163S, RTX600179S, RTX600202S, RTX600231S, RTX600243S, RTX600247S, RTX600249S, RTX600251S, RTX600252S, RTX600258S, RTX600262S, RTX600268S, RTX600269S, RTX600278S, RTX600286S, RTX600463S, RTX600464S, RTX600466S, RTX600467S, RTX600471S, RTX600472S, RTX600474S, RTX600475S, RTX600476S, RTX600477S, RTX600478S, RTX600482S, RTX600483S, RTX600484S, RTX600485S, RTX600486S, RTX600487S, RTX600490S, RTX600491S, RTX600492S, RTX600493S, RTX600494S, RTX600495S, RTX600500S, RTX600501S, RTX600502S, RTX600503S, RTX600505S, RTX600506S, RTX600507S, RTX600508S, RTX600509S, RTX600510S, RTX600511S, RTX600512S, RTX600513S, RTX600514S, RTX600515S, RTX600516S, RTX600517S, RTX600518S, RTX600521S, RTX600530S, RTX600532S, RTX600533S, RTX600534S, RTX600535S, RTX600536S, RTX600537S, RTX600538S, RTX600539S, RTX600541S, RTX600542S, RTX600543S, RTX600544S, RTX600546S, RTX600547S, RTX600548S, RTX600549S, RTX600550S, RTX600551S, RTX600552S, RTX600554S, RTX600555S, RTX600556S, RTX600557S, RTX600558S, RTX600559S, RTX600560S, RTX600561S, RTX600564S, RTX600566S, RTX600567S, RTX600568S, RTX600569S, RTX600570S, RTX600571S, RTX600572S, RTX600573S, RTX600574S, RTX600575S, RTX600576S, RTX600577S, RTX600578S, RTX600579S, RTX600598S, RTX600600S, RTX600602S, RTX600603S, RTX600604S, RTX600605S, RTX600606S, RTX600607S, RTX600608S, RTX600609S, RTX600610S, RTX600611S, RTX600612S, RTX600613S, RTX600615S, RTX600618S, RTX600619S, RTX600620S, RTX600621S, RTX600622S, RTX600623S, RTX600624S, RTX600625S, RTX600626S, RTX600627S, RTX600628S, RTX600629S, RTX600630S, RTX600631S, RTX600632S; b. Model Numbers: DTPC2QQ: GTIN 00763000178253, Serial Numbers: RTS600220S, RTS600260S, RTS600972S; GTIN 00763000178277, Serial Numbers: RTS600014S, RTS600015S, RTS600016S, RTS600017S, RTS600018S, RTS600020S, RTS600022S, RTS600024S, RTS600026S, RTS600027S, RTS600029S, RTS600030S, RTS600031S, RTS600032S, RTS600034S, RTS600035S, RTS600036S, RTS600037S, RTS600038S, RTS600039S, RTS600041S, RTS600042S, RTS600043S, RTS600044S, RTS600045S, RTS600048S, RTS600050S, RTS600051S, RTS600053S, RTS600055S, RTS600056S, RTS600058S, RTS600060S, RTS600061S, RTS600063S, RTS600064S, RTS600066S, RTS600069S, RTS600228S, RTS600235S, RTS600274S, RTS600275S, RTS600281S, RTS600284S, RTS600286S, RTS600292S, RTS600293S, RTS600295S, RTS600296S, RTS600300S, RTS600301S, RTS600302S, RTS600303S, RTS600304S, RTS600305S, RTS600306S, RTS600308S, RTS600309S, RTS600310S, RTS600311S, RTS600312S, RTS600313S, RTS600315S, RTS600317S, RTS600318S, RTS600319S, RTS600320S, RTS600321S, RTS600323S, RTS600325S, RTS600326S, RTS600327S, RTS600328S, RTS600329S, RTS600330S, RTS600331S, RTS600333S, RTS600335S, RTS600337S, RTS600343S, RTS600344S, RTS600345S, RTS600346S, RTS600348S, RTS600349S, RTS600351S, RTS600352S, RTS600353S, RTS600354S, RTS600355S, RTS600356S, RTS600358S, RTS600359S, RTS600360S, RTS600369S, RTS600373S, RTS600425S, RTS600426S, RTS600441S, RTS600484S, RTS600485S, RTS600486S, RTS600487S, RTS600488S, RTS600489S, RTS600490S, RTS600491S, RTS600492S, RTS600493S, RTS600494S, RTS600495S, RTS600496S, RTS600497S, RTS600498S, RTS600510S, RTS600511S, RTS600512S, RTS600513S, RTS600514S, RTS600515S, RTS600516S, RTS600517S, RTS600518S, RTS600519S, RTS600520S, RTS600521S, RTS600522S, RTS600524S, RTS600525S, RTS600526S, RTS600527S, RTS600528S, RTS600529S, RTS600530S, RTS600531S, RTS600532S, RTS600533S, RTS600534S, RTS600535S, RTS600536S, RTS600538S, RTS600539S, RTS600540S, RTS600541S, RTS600542S, RTS600543S, RTS600554S, RTS600555S, RTS600556S, RTS600557S, RTS600558S, RTS600559S, RTS600560S, RTS600561S, RTS600562S, RTS600563S, RTS600564S, RTS600565S, RTS600566S, RTS600567S, RTS600568S, RTS600569S, RTS600570S, RTS600571S, RTS600572S, RTS600573S, RTS600574S, RTS600575S, RTS600576S, RTS600577S, RTS600578S, RTS600579S, RTS600580S, RTS600581S, RTS600582S, RTS600583S, RTS600584S, RTS600585S, RTS600586S, RTS600587S, RTS600588S, RTS600590S, RTS600592S, RTS600596S, RTS600597S, RTS600600S, RTS600605S, RTS600606S, RTS600607S, RTS600610S, RTS600611S, RTS600616S, RTS600629S, RTS600637S, RTS600638S, RTS600639S, RTS600643S, RTS600648S, RTS600650S, RTS600651S, RTS600656S, RTS600661S, RTS600663S, RTS600665S, RTS600667S, RTS600671S, RTS600673S, RTS600675S, RTS600676S, RTS600677S, RTS600679S, RTS600687S, RTS600693S, RTS600697S, RTS600698S, RTS600700S, RTS600705S, RTS600706S, RTS600719S, RTS600720S, RTS600833S, RTS600842S, RTS600846S, RTS600849S, RTS600852S, RTS600857S, RTS600866S, RTS600874S, RTS600880S, RTS600883S, RTS600884S, RTS600885S, RTS600886S, RTS600888S, RTS600889S, RTS600897S, RTS600900S, RTS600901S, RTS600908S, RTS600910S, RTS600911S, RTS600912S, RTS600913S, RTS600914S, RTS600915S, RTS600916S, RTS600917S, RTS600918S, RTS600919S, RTS600920S, RTS600921S, RTS600922S, RTS600923S, RTS600924S, RTS600925S, RTS600926S, RTS600927S, RTS600928S, RTS600929S, RTS600930S, RTS600931S, RTS600932S, RTS600933S, RTS600934S, RTS600936S, RTS600937S, RTS600938S, RTS600939S, RTS600940S, RTS600941S, RTS600943S, RTS600944S, RTS600945S, RTS600947S, RTS600948S, RTS600949S, RTS600957S, RTS600959S, RTS600967S, RTS600991S, RTS600993S, RTS600995S, RTS600997S, RTS600998S, RTS600999S, RTS601000S, RTS601001S, RTS601002S, RTS601003S, RTS601007S, RTS601008S, RTS601009S, RTS601012S, RTS601017S, RTS601019S, RTS601020S, RTS601021S, RTS601022S, RTS601024S, RTS601029S, RTS601034S, RTS601036S, RTS601038S, RTS601039S, RTS601040S, RTS601041S, RTS601042S, RTS601043S, RTS601044S, RTS601045S, RTS601047S, RTS601048S, RTS601049S, RTS601050S, RTS601051S, RTS601052S, RTS601053S, RTS601054S, RTS601055S, RTS601056S, RTS601057S, RTS601058S, RTS601059S, RTS601060S, RTS601061S, RTS601062S, RTS601063S, RTS601064S, RTS601065S, RTS601066S, RTS601067S, RTS601070S, RTS601071S, RTS601082S, RTS601086S, RTS601087S, RTS601091S, RTS601098S, RTS601100S, RTS601101S, RTS601103S, RTS601105S, RTS601107S, RTS601110S, RTS601111S, RTS601112S, RTS601115S, RTS601116S, RTS601117S, RTS601118S, RTS601119S, RTS601120S, RTS601121S, RTS601122S, RTS601123S, RTS601124S, RTS601125S, RTS601126S, RTS601127S, RTS601128S, RTS601129S, RTS601130S, RTS601131S, RTS601132S, RTS601133S, RTS601134S, RTS601135S, RTS601136S, RTS601137S, RTS601138S, RTS601139S, RTS601140S, RTS601141S, RTS601142S, RTS601143S, RTS601144S, RTS601145S, RTS601146S, RTS601147S, RTS601148S, RTS601149S, RTS601150S, RTS601151S, RTS601152S, RTS601155S, RTS601158S, RTS601159S, RTS601160S, RTS601161S, RTS601163S, RTS601164S, RTS601165S, RTS601166S, RTS601167S, RTS601168S, RTS601169S, RTS601170S, RTS601171S, RTS601172S, RTS601173S, RTS601174S, RTS601175S, RTS601176S, RTS601177S, RTS601178S, RTS601179S, RTS601180S, RTS601181S, RTS601182S, RTS601183S, RTS601184S, RTS601185S, RTS601186S, RTS601187S, RTS601188S, RTS601189S, RTS601190S, RTS601191S, RTS601192S, RTS601193S, RTS601194S, RTS601195S, RTS601198S, RTS601199S, RTS601200S, RTS601201S, RTS601202S, RTS601203S, RTS601204S, RTS601205S, RTS601206S, RTS601207S, RTS601208S, RTS601209S, RTS601210S, RTS601211S, RTS601212S, RTS601215S, RTS601216S, RTS601217S, RTS601218S, RTS601219S, RTS601220S, RTS601221S, RTS601223S, RTS601224S, RTS601225S, RTS601226S, RTS601227S, RTS601228S, RTS601229S, RTS601230S, RTS601231S, RTS601232S, RTS601233S, RTS601234S, RTS601235S, RTS601236S, RTS601237S, RTS601238S, RTS601240S, RTS601242S; DTPC2Q1: GTIN 00763000178260, Serial Numbers: RTT600423S, RTT600424S, RTT600434S; GTIN 00763000178284, Serial Numbers: RTT600010S, RTT600015S, RTT600016S, RTT600017S, RTT600023S, RTT600133S, RTT600135S, RTT600142S, RTT600148S, RTT600196S, RTT600204S, RTT600215S, RTT600304S, RTT600305S, RTT600307S, RTT600308S, RTT600309S, RTT600314S, RTT600315S, RTT600316S, RTT600318S, RTT600319S, RTT600323S, RTT600326S, RTT600327S, RTT600329S, RTT600330S, RTT600331S, RTT600334S, RTT600335S, RTT600337S, RTT600338S, RTT600341S, RTT600342S, RTT600343S, RTT600344S, RTT600345S, RTT600346S, RTT600347S, RTT600348S, RTT600350S, RTT600351S, RTT600353S, RTT600354S, RTT600355S, RTT600357S, RTT600358S, RTT600359S, RTT600360S, RTT600361S, RTT600363S, RTT600365S, RTT600368S, RTT600369S, RTT600370S, RTT600371S, RTT600372S, RTT600373S, RTT600374S, RTT600375S, RTT600376S, RTT600377S, RTT600378S, RTT600380S, RTT600382S, RTT600383S, RTT600386S, RTT600387S, RTT600388S, RTT600389S, RTT600391S, RTT600392S, RTT600393S, RTT600394S, RTT600396S, RTT600397S, RTT600398S, RTT600399S, RTT600400S, RTT600401S, RTT600402S, RTT600403S, RTT600404S, RTT600405S, RTT600406S, RTT600407S, RTT600408S, RTT600409S, RTT600410S, RTT600411S, RTT600412S, RTT600413S, RTT600414S, RTT600415S, RTT600416S, RTT600417S, RTT600418S, RTT600419S, RTT600428S, RTT600442S, RTT600443S, RTT600444S, RTT600445S, RTT600446S, RTT600447S, RTT600448S, RTT600449S, RTT600451S, RTT600452S, RTT600454S, RTT600455S.

Quantity Affected: 866 units

Reason for Recall

There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

Type: Voluntary: Firm initiated

Recall Initiated: 2022-06-22

Company