CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators

Summary

The FDA issued a Class I for CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardiov by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillato.

Details

Product Description

CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators

Lot/Code Info: GTIN 00643169837614, Lot Serial numbers: RPN602297S, RPN602079S, RPN601385S, RPN601320S, RPN601216S, RPN601977S, RPN602107S, RPN600885S, RPN601199S, RPN600682S, RPN601504S, RPN601513S, RPN601653S, RPN601681S, RPN602258S, RPN600961S, RPN600858S, RPN600867S, RPN600868S, RPN600942S, RPN601384S, RPN601398S, RPN601516S, RPN601873S, RPN601874S, RPN602264S, RPN602302S, RPN602350S, RPN602422S, RPN602462S, RPN602468S, RPN602507S, RPN601042S, RPN601529S, RPN602434S, RPN601306S, RPN601439S, RPN602416S, RPN601214S, RPN601763S, RPN601891S, RPN600750S, RPN601165S, RPN600770S, RPN601245S, RPN602186S, RPN602293S, RPN600666S, RPN600683S, RPN601094S, RPN601229S, RPN601277S, RPN601298S, RPN601393S, RPN601662S, RPN602160S, RPN600812S, RPN601674S, RPN602429S, RPN600678S, RPN602335S, RPN602420S, RPN601154S, RPN601660S, RPN602247S, RPN602355S, RPN602463S, RPN600888S, RPN601753S, RPN601619S, RPN600829S, RPN601839S, RPN601845S, RPN602501S, RPN602393S, RPN600717S, RPN600808S, RPN602021S, 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RPN602213S, RPN602266S, RPN602280S, RPN602466S, RPN602467S, RPN602011S, RPN602103S, RPN601116S, RPN601390S, RPN600834S, RPN601183S, RPN601356S, RPN601676S, RPN600950S, RPN600695S, RPN601099S, RPN602016S, RPN601191S, RPN601194S, RPN601958S, RPN601553S, RPN601876S, RPN602233S, RPN602250S, RPN601555S, RPN602323S, RPN601872S, RPN601675S, RPN602334S, RPN601220S, RPN602324S, RPN600627S, RPN602332S, RPN600620S, RPN601444S, RPN601149S, RPN601465S, RPN600655S, RPN600878S, RPN601019S, RPN601035S, RPN601145S, RPN601147S, RPN601202S, RPN601205S, RPN601262S, RPN601265S, RPN601348S, RPN601481S, RPN601498S, RPN601646S, RPN601684S, RPN601732S, RPN601020S, RPN601074S, RPN601139S, RPN601686S, RPN602165S, RPN601489S, RPN601292S, RPN601849S, RPN601247S, RPN601350S, RPN601700S, RPN600881S, RPN601138S, RPN601427S, RPN601630S, RPN601833S, RPN602159S, RPN601303S, RPN601671S, RPN601973S, RPN601443S, RPN602035S, RPN601365S, RPN601266S, RPN601943S, RPN601999S, RPN600988S, RPN600603S, RPN601343S, RPN601364S, RPN601452S, RPN601454S, RPN601506S, RPN601613S, RPN601657S, RPN601755S, RPN601757S, RPN601855S, RPN602031S, RPN600721S, RPN601103S, RPN601150S, RPN601342S, RPN601359S, RPN601464S, RPN601469S, RPN601495S, RPN601629S, RPN601680S, RPN601857S, RPN602116S, RPN602127S, RPN602149S, RPN602402S, RPN601599S, RPN601631S, RPN601011S, RPN600643S, RPN601938S, RPN602057S, RPN601682S, RPN601913S, RPN601944S, RPN600609S, RPN601107S, RPN601140S, RPN601185S, RPN601491S, RPN601078S, RPN601234S, RPN601428S, RPN601739S, RPN602038S, RPN601125S, RPN601131S, RPN601382S, RPN601402S, RPN601161S, RPN601345S, RPN601419S, RPN601476S, RPN601086S, RPN601088S, RPN601188S, RPN601360S, RPN601405S, RPN601677S, RPN602404S, RPN600672S, RPN601198S, RPN601426S, RPN601968S, RPN602008S, RPN601207S, RPN601708S, RPN601313S, RPN601032S, RPN601475S, RPN601706S, RPN601742S, RPN600705S, RPN601448S, RPN601473S, RPN601940S, RPN601171S, RPN601341S, RPN601347S, RPN601635S, RPN601942S, RPN601586S, RPN601997S, RPN602401S, RPN600644S, RPN600706S, RPN601101S, RPN601196S, RPN601858S, RPN601976S, RPN602072S, RPN601143S, RPN601353S, RPN601396S, RPN601483S, RPN601723S, RPN601750S, RPN601678S, RPN600617S, RPN600634S, RPN601071S, RPN601597S, RPN600630S, RPN601110S, RPN601437S, RPN601446S, RPN601752S, RPN601928S, RPN601991S, RPN601085S, RPN601430S, RPN602071S, RPN602399S, RPN602400S, RPN600480S, RPN601994S, RPN601912S, RPN602097S, RPN601990S, RPN601072S, RPN601449S, RPN601499S, RPN601251S, RPN601084S, RPN601890S, RPN601484S, RPN601024S, RPN601346S, RPN601080S, RPN601308S, RPN600656S, RPN601316S, RPN601667S, RPN602046S, RPN601403S, RPN601926S, RPN600618S, RPN601400S, RPN601720S, RPN601865S, RPN601089S, RPN601326S, RPN602052S, RPN601468S, RPN601624S, RPN602124S, RPN600953S, RPN601028S, RPN600939S, RPN602341S, RPN602209S, RPN601434S, RPN602414S, RPN600626S, RPN600660S, RPN600791S, RPN601203S, RPN601274S, RPN602049S, RPN602129S, RPN602131S, RPN602148S, RPN602326S, RPN600671S, RPN600757S, RPN601001S, RPN601053S, RPN601565S, RPN601719S, RPN602130S, RPN602156S, RPN602440S, RPN602263S, RPN602353S, RPN600902S, RPN602480S, RPN601029S, RPN601111S, RPN601407S, RPN600875S, RPN601460S, RPN602163S, RPN602227S, RPN601036S, RPN601283S, RPN601344S, RPN601352S, RPN601705S, RPN602477S, RPN602478S, RPN602481S, RPN602482S, RPN602484S, RPN600710S, RPN601195S, RPN601898S, RPN602273S, RPN602494S, RPN601666S, RPN600598S, RPN600728S, RPN601925S, RPN600703S, RPN600720S, RPN601870S, RPN601988S, RPN602343S, RPN601931S, RPN601892S, RPN600980S, RPN600989S, RPN601477S, RPN601560S, RPN602225S, RPN602419S, RPN602461S, RPN601955S, RPN601715S, RPN602339S, RPN602285S; GTIN 00763000206239, Lot Serial Numbers: RPN602735S, RPN603088S, RPN602982S, RPN602524S, RPN602992S, RPN603144S, RPN603019S, RPN602975S, RPN602997S, RPN603139S, RPN602843S, RPN602891S, RPN602839S, RPN602991S, RPN603153S, RPN602756S, RPN602766S, RPN602554S, RPN602750S, RPN602907S, RPN602874S, RPN602945S, RPN602836S, RPN602856S, RPN602717S, RPN602774S, RPN602795S, RPN602995S, RPN602685S, RPN602779S, RPN602876S, RPN602759S, RPN602696S, RPN602953S, RPN602786S, RPN602800S, RPN602862S, RPN602893S, RPN603084S, RPN602761S, RPN603093S, RPN602792S, RPN602898S, RPN603038S, RPN602694S, RPN602772S, RPN602709S, RPN602879S, RPN602758S, RPN602675S, RPN602661S, RPN602925S, RPN602782S, RPN602656S, RPN603050S, RPN602824S, RPN603111S, RPN602968S, RPN602698S, RPN602699S, RPN602700S, RPN602701S, RPN602724S, RPN602747S, RPN602768S, RPN602823S, RPN602825S, RPN602826S, RPN603096S, RPN602828S, RPN603034S, RPN602580S, RPN602720S, RPN602687S, RPN602688S, RPN602829S, RPN603035S, RPN603162S, RPN602838S, RPN602835S, RPN602888S, RPN602912S, RPN602957S, RPN603036S, RPN602806S, RPN603000S, RPN602739S, RPN602770S, RPN602917S, RPN602841S, RPN602765S, RPN602537S, RPN602346S, RPN602802S, RPN602691S, RPN602668S, RPN602670S, RPN602719S, RPN602722S, RPN602749S, RPN602787S, RPN602855S, RPN603053S, RPN602745S, RPN602834S, RPN602564S, RPN602783S, RPN602347S, RPN602790S, RPN602740S, RPN602880S, RPN602941S, RPN602526S, RPN602743S, RPN602679S, RPN602796S, RPN602900S, RPN603140S, RPN602657S, RPN602660S, RPN602682S, RPN602726S, RPN602801S, RPN603141S, RPN602921S, RPN602607S, RPN602630S, RPN602840S, RPN603013S, RPN602345S, RPN602572S, RPN602597S, RPN602600S, RPN602723S, RPN602754S, RPN602799S, RPN602847S, RPN602877S, RPN602643S, RPN602686S, RPN602706S, RPN602793S, RPN602680S, RPN602810S, RPN603048S, RPN602658S, RPN602665S, RPN602674S, RPN602731S, RPN602755S, RPN602781S, RPN602837S, RPN603028S, RPN603158S, RPN603159S, RPN602593S, RPN602581S, RPN602773S, RPN602697S, RPN602894S, RPN602895S, RPN602896S, RPN602710S, RPN602584S, RPN602718S, RPN602860S, RPN602708S, RPN602753S, RPN602645S, RPN602913S, RPN602914S, RPN602918S, RPN603102S, RPN603147S, RPN602702S, RPN602532S, RPN602778S, RPN603024S, RPN602964S, RPN602608S, RPN602558S, RPN602612S, RPN602518S, RPN602533S, RPN602969S, RPN602536S, RPN602567S, RPN602831S, RPN602791S, RPN602609S, RPN603016S, RPN602797S, RPN602568S, RPN602695S, RPN602757S, RPN602911S, RPN602870S, RPN602919S, RPN602846S, RPN602741S, RPN603010S, RPN602949S, RPN602944S, RPN602947S, RPN602984S, RPN602987S, RPN602999S, RPN603002S, RPN602575S, RPN602602S, RPN602606S, RPN602610S, RPN602662S, RPN602833S, RPN602937S, RPN602951S, RPN602579S, RPN602654S, RPN602673S, RPN602684S, RPN602943S, RPN602713S, RPN602853S, RPN602535S, RPN602681S, RPN603132S, RPN602707S, RPN602803S, RPN602571S, RPN602522S, RPN602734S, RPN602820S, RPN602509S, RPN602909S, RPN602930S, RPN603003S, RPN602553S, RPN602587S, RPN602543S, RPN602523S, RPN602549S, RPN602552S, RPN602531S, RPN602852S, RPN602570S, RPN602565S, RPN603062S, RPN602550S, RPN602986S, RPN602578S, RPN602813S, RPN602547S, RPN602561S, RPN602985S, RPN602586S, RPN602513S, RPN602928S, RPN602514S, RPN602563S, RPN602819S, RPN602857S, RPN602555S, RPN602927S, RPN602730S, RPN602901S, RPN602551S, RPN602546S, RPN602573S, RPN602574S, RPN602666S, RPN602849S, RPN602923S, RPN602926S, RPN602932S, RPN602956S, RPN603086S, RPN602940S, RPN602924S, RPN602519S, RPN602527S, RPN602528S, RPN602632S, RPN602633S, RPN602980S, RPN602510S, RPN602659S, RPN602712S, RPN602715S, RPN602742S, RPN602752S, RPN602771S, RPN602776S, RPN602784S, RPN602809S, RPN602811S, RPN602814S, RPN602815S, RPN602817S, RPN602842S, RPN602844S, RPN602859S, RPN602872S, RPN602873S, RPN602884S, RPN602885S, RPN602890S, RPN602897S, RPN602902S, RPN602903S, RPN602905S, RPN602906S, RPN602910S, RPN602929S, RPN602933S, RPN602934S, RPN602946S, RPN602948S, RPN602950S, RPN602952S, RPN602958S, RPN602959S, RPN602960S, RPN602962S, RPN602966S, RPN602967S, RPN602974S, RPN602983S, RPN602993S, RPN602994S, RPN602996S, RPN602998S, RPN603007S, RPN603009S, RPN603015S, RPN603017S, RPN603031S, RPN603032S, RPN603051S, RPN603052S, RPN603054S, RPN603055S, RPN603056S, RPN603074S, RPN603077S, RPN603079S, RPN603082S, RPN603118S, RPN603121S, RPN603123S, RPN603124S, RPN603145S, RPN603152S, RPN603165S, RPN603171S, RPN603173S, RPN603174S, RPN603177S, RPN603178S, RPN603181S, RPN602892S, RPN602961S, RPN602972S, RPN602973S, RPN603094S, RPN603095S, RPN602515S

Quantity Affected: 1658 units

Reason for Recall

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-05-10

Company