Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328
Description: CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1729-2023 |
| Event ID | 92328 |
| Event Description | CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators |
| Product Type | Devices |
| Distribution | US Nationwide - Worldwide Distribution |
| Quantity | 1473 units |
| Recall Reason | 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. |
| Device Classification | 20230628 |
| Device Code Info | GTIN 00643169720312, Lot Serial Numbers: BLF258142H, BLF257918H, BLF258186H, BLF258209H, BLF257508H, BLF258084H, BLF257081H, BLF257089H, BLF257260H, BLF257290H, BLF257410H, BLF257440H, BLF257565H, BLF257668H, BLF257684H, BLF257873H, BLF257966H, BLF256897H, BLF257648H, BLF256756H, BLF256776H, BLF256865H, BLF257835H, BLF257086H, BLF257198H, BLF257413H, BLF257605H, BLF257611H, BLF257863H, BLF257960H, BLF257342H, BLF257460H, BLF257657H, BLF256948H, BLF257877H, BLF256848H, BLF257404H, BLF257931H, BLF257961H, BLF258043H, BLF258080H, BLF257904H, BLF257104H, BLF257029H, BLF257408H, BLF257431H, BLF257388H, BLF257618H, BLF257916H, BLF257972H, BLF256843H, BLF256844H, BLF256971H, BLF257125H, BLF257347H, BLF258090H, BLF257677H, BLF258051H, BLF257844H, BLF257627H, BLF257348H, BLF258261H, BLF257215H, BLF257468H, BLF256758H, BLF257803H, BLF258143H, BLF257449H, BLF257885H, BLF257899H, BLF257956H, BLF258078H, BLF258093H, BLF258094H, BLF258178H, BLF258228H, BLF257037H, BLF257384H, BLF258292H, BLF257430H, BLF257459H, BLF256911H, BLF256979H, BLF256984H, BLF256999H, BLF257398H, BLF257568H, BLF257682H, BLF258129H, BLF258141H, BLF258202H, BLF258219H, BLF258236H, BLF258294H, BLF256867H, BLF257276H, BLF258268H, BLF256968H, BLF256969H, BLF257429H, BLF257843H, BLF257437H, BLF257532H, BLF257054H, BLF257651H, BLF256785H, BLF256799H, BLF257456H, BLF258254H, BLF256780H, BLF257014H, BLF258185H, BLF256985H, BLF257147H, BLF257832H, BLF257606H, BLF257866H, BLF256874H, BLF256883H, BLF257230H, BLF257253H, BLF257636H, BLF257807H, BLF257868H, BLF257927H, BLF257933H, BLF257986H, BLF258140H, BLF258169H, BLF258199H, BLF258239H, BLF258250H, BLF255363H, BLF257634H, BLF257639H, BLF257780H, BLF257781H, BLF257782H, BLF257785H, BLF257787H, BLF257788H, BLF257791H, BLF257794H, BLF257879H, BLF258289H, BLF258291H, BLF257350H, BLF256962H, BLF257401H, BLF258055H, BLF256900H, BLF257394H, BLF257746H, BLF258172H, BLF258041H, BLF257615H, BLF258180H, BLF256995H, BLF257576H, BLF258040H, BLF256915H, BLF258159H, BLF257279H, BLF257826H, BLF257968H, BLF258069H, BLF258072H, BLF258276H, BLF257139H, BLF257614H, BLF257470H, BLF257630H, BLF258074H, BLF258106H, BLF258170H, BLF257012H, BLF257155H, BLF258057H, BLF258066H, BLF257530H, BLF257025H, BLF257422H, BLF257487H, BLF257525H, BLF257550H, BLF257864H, BLF257203H, BLF256828H, BLF257035H, BLF257343H, BLF257091H, BLF258295H, BLF257423H, BLF257213H, BLF257397H, BLF257604H, BLF257823H, BLF258011H, BLF257173H, BLF257291H, BLF257386H, BLF257678H, BLF257755H, BLF257773H, BLF257867H, BLF257997H, BLF258076H, BLF258183H, BLF257502H, BLF257420H, BLF256841H, BLF258088H, BLF257092H, BLF257482H, BLF257195H, BLF257529H, BLF257099H, BLF257171H, BLF257617H, BLF257583H, BLF257999H, BLF256870H, BLF256931H, BLF256936H, BLF256965H, BLF257024H, BLF257132H, BLF257144H, BLF257150H, BLF257151H, BLF257152H, BLF257177H, BLF257360H, BLF257395H, BLF257523H, BLF257620H, BLF257642H, BLF257676H, BLF258022H, BLF258060H, BLF258191H, BLF258211H, BLF258213H, BLF258214H, BLF258222H, BLF257824H, BLF258052H, BLF257747H, BLF256906H, BLF257009H, BLF257245H, BLF257352H, BLF257596H, BLF258085H, BLF258260H, BLF257122H, BLF256789H, BLF256833H, BLF256869H, BLF257149H, BLF258139H, BLF257137H, BLF257071H, BLF257157H, BLF257560H, BLF257856H, BLF257910H, BLF257356H, BLF257865H, BLF257875H, BLF257993H, BLF256860H, BLF257409H, BLF257504H, BLF256767H, BLF257601H, BLF256959H, BLF257383H, BLF257450H, BLF257998H, BLF258083H, BLF257141H, BLF257286H, BLF257675H, BLF257498H, BLF256757H, BLF257134H, BLF257180H, BLF257436H, BLF257480H, BLF256845H, BLF256961H, BLF257322H, BLF257370H, BLF257507H, BLF257512H, BLF257762H, BLF258008H, BLF258009H, BLF258184H, BLF256877H, BLF256950H, BLF257027H, BLF256857H, BLF256960H, BLF256829H, BLF257369H, BLF257060H, BLF258131H, BLF257234H, BLF257248H, BLF257389H, BLF257696H, BLF257901H, BLF257233H, BLF258103H, BLF256991H, BLF257490H, BLF257632H, BLF258152H, BLF256891H, BLF257156H, BLF257907H, BLF257987H, BLF256909H, BLF257250H, BLF256849H, BLF256769H, BLF257351H, BLF257411H, BLF257974H, BLF257119H, BLF257952H, BLF257120H, BLF257345H, BLF256954H, BLF257005H, BLF257182H, BLF257235H, BLF257237H, BLF257412H, BLF257414H, BLF257559H, BLF257638H, BLF257640H, BLF257650H, BLF257674H, BLF257822H, BLF257861H, BLF257990H, BLF258045H, BLF258077H, BLF258116H, BLF258155H, BLF258158H, BLF258160H, BLF258176H, BLF258201H, BLF258215H, BLF258243H, BLF257777H, BLF258061H, BLF257076H, BLF257294H, BLF257494H, BLF257834H, BLF257882H, BLF257979H, BLF258277H, BLF256854H, BLF256873H, BLF256952H, BLF257913H, BLF257292H, BLF257427H, BLF257057H, BLF257679H, BLF257365H, BLF258196H, BLF258235H, BLF256872H, BLF256882H, BLF256955H, BLF256976H, BLF257269H, BLF257598H, BLF258227H, BLF256927H, BLF257007H, BLF257019H, BLF257063H, BLF257287H, BLF258298H, BLF257402H, BLF256804H, BLF257385H, BLF256919H, BLF257515H, BLF256953H, BLF257591H, BLF257593H, BLF257694H, BLF257802H, BLF257897H, BLF258205H, BLF257079H, BLF257244H, BLF257499H, BLF256973H, BLF257892H, BLF256818H, BLF257016H, BLF257077H, BLF257380H, BLF257452H, BLF257458H, BLF257478H, BLF257521H, BLF257526H, BLF257661H, BLF257683H, BLF257805H, BLF257871H, BLF258226H, BLF257183H, BLF257256H, BLF257329H, BLF258109H, BLF258237H, BLF257210H, BLF257004H, BLF257117H, BLF257510H, BLF258059H, BLF257043H, BLF257381H, BLF257757H, BLF258148H, BLF256822H, BLF257566H, BLF257200H, BLF257582H, BLF258181H, BLF258241H, BLF256762H, BLF256821H, BLF256853H, BLF256884H, BLF257335H, BLF257362H, BLF257731H, BLF257953H, BLF258194H, BLF258204H, BLF257859H, BLF257536H, BLF257616H, BLF257625H, BLF256886H, BLF256764H, BLF257971H, BLF257283H, BLF257175H, BLF258065H, BLF256773H, BLF257564H, BLF257567H, BLF257896H, BLF258210H, BLF257540H, BLF257265H, BLF256774H, BLF257236H, BLF257588H, BLF256784H, BLF256871H, BLF256932H, BLF256933H, BLF256934H, BLF256938H, BLF256939H, BLF256940H, BLF256941H, BLF256943H, BLF257883H, BLF257888H, BLF257890H, BLF257891H, BLF257893H, BLF257013H, BLF257262H, BLF257453H, BLF257571H, BLF257929H, BLF257547H, BLF258212H, BLF256778H, BLF256805H, BLF256806H, BLF256807H, BLF256808H, BLF256809H, BLF256810H, BLF256812H, BLF257189H, BLF257191H, BLF257192H, BLF257194H, BLF257324H, BLF257129H, BLF257441H, BLF256945H, BLF256946H, BLF257074H, BLF257393H, BLF257655H, BLF257795H, BLF257798H, BLF258012H, BLF258014H, BLF258018H, BLF258021H, BLF258024H, BLF258247H, BLF258265H, BLF258266H, BLF258269H, BLF258273H, BLF256896H, BLF256905H, BLF258091H, BLF256895H, BLF257094H, BLF258042H, BLF256770H, BLF256832H, BLF256834H, BLF256835H, BLF257424H, BLF257462H, BLF257921H, BLF258285H, BLF257338H, BLF258245H, BLF258293H, BLF256898H, BLF257438H, BLF258079H, BLF257833H, BLF258130H, BLF257331H, BLF257201H, BLF257889H, BLF258013H, BLF257170H, BLF256899H, BLF258132H, BLF258267H, BLF257103H, BLF256922H, BLF257088H, BLF257649H, BLF257097H, BLF257551H, BLF257572H, BLF256837H, BLF257161H, BLF257948H, BLF257454H, BLF257828H, BLF258124H, BLF258296H, BLF257669H, BLF258145H, BLF258153H, BLF256890H, BLF257178H, BLF257241H, BLF257692H, BLF257962H, BLF258242H, BLF257434H, BLF257637H, BLF256751H, BLF256787H, BLF256827H, BLF256836H, BLF256861H, BLF257543H, BLF257932H, BLF256892H, BLF256980H, BLF257895H, BLF257838H, BLF258089H, BLF258102H, BLF258173H, BLF257229H, BLF257903H, BLF258062H, BLF256781H, BLF256792H, BLF256798H, BLF257000H, BLF257021H, BLF257059H, BLF257083H, BLF257090H, BLF257116H, BLF257118H, BLF257121H, BLF257226H, BLF257391H, BLF257419H, BLF257477H, BLF257538H, BLF257624H, BLF257817H, BLF257839H, BLF257939H, BLF258056H, BLF258086H, BLF257513H, BLF257959H, BLF257464H, BLF257902H, BLF256859H, BLF256879H, BLF257426H, BLF257448H, BLF258000H, BLF258138H, BLF258171H, BLF258217H, BLF257001H, BLF257030H, BLF257033H, BLF257204H, BLF257501H, BLF257687H, BLF257850H, BLF258119H, BLF256894H, BLF255367H, BLF256957H, BLF257243H, BLF257138H, BLF257654H, BLF257126H, BLF255365H, BLF257015H, BLF257363H, BLF257378H, BLF257390H, BLF257473H, BLF257475H, BLF256904H, BLF257131H, BLF257405H, BLF257925H, BLF256823H, BLF256824H, BLF257218H, BLF257219H, BLF257223H, BLF258010H, BLF258134H, BLF258224H, BLF258230H, BLF258240H, BLF258279H, BLF256754H, BLF257631H, BLF258101H, BLF258286H, BLF257239H, BLF256866H, BLF257080H, BLF257084H, BLF257163H, BLF257272H, BLF257527H, BLF257569H, BLF257686H, BLF257813H, BLF257900H, BLF258151H, BLF258187H, BLF258037H, BLF257003H, BLF257264H, BLF257573H, BLF257662H, BLF257698H, BLF257756H, BLF257876H, BLF257878H, BLF257880H, BLF257881H, BLF257950H, BLF258028H, BLF258029H, BLF257472H, BLF257471H, BLF257146H, BLF257320H, BLF257656H, BLF256996H, BLF257093H, BLF257098H, BLF257912H, BLF257628H, BLF258097H, BLF257281H, BLF258150H, BLF256978H, BLF257298H, BLF256912H, BLF257646H, BLF258048H, BLF256990H, BLF258068H, BLF256881H, BLF258234H, BLF257814H, BLF256975H, BLF257318H, BLF257688H, BLF257940H, BLF258161H, BLF257862H, BLF257894H, BLF258123H, BLF256777H, BLF257816H, BLF258108H, BLF258110H, BLF258232H, BLF258246H, BLF258274H, BLF257040H, BLF257578H, BLF257164H, BLF257032H, BLF257069H, BLF257727H, BLF258115H, BLF257319H, BLF257425H, BLF257303H, BLF256893H, BLF257046H, BLF257336H, BLF257377H, BLF257561H, BLF258053H, BLF258136H, BLF258144H, BLF257297H, BLF257357H, BLF257761H, BLF256750H, BLF257666H, BLF258082H, BLF258284H, BLF256840H, BLF257919H, BLF257300H, BLF256830H, BLF256914H, BLF257387H, BLF257633H, BLF257806H, BLF258244H, BLF257127H, BLF257497H, BLF257206H, BLF257207H, BLF257208H, BLF257209H, BLF257184H, BLF258271H, BLF257603H, BLF257162H, BLF257580H, BLF258207H, BLF256887H, BLF257575H, BLF256916H, BLF256924H, BLF257034H, BLF257143H, BLF258117H, BLF258070H, BLF257372H, BLF257917H, BLF257306H, BLF257558H, BLF257811H, BLF257831H, BLF258238H, BLF257435H, BLF256852H, BLF257830H, BLF258122H, BLF257317H, BLF257989H, BLF256986H, BLF257028H, BLF257038H, BLF257041H, BLF257113H, BLF257366H, BLF257923H, BLF257934H, BLF258005H, BLF258203H, BLF258216H, BLF258221H, BLF257128H, BLF257227H, BLF257647H, BLF257709H, BLF257710H, BLF257711H, BLF257720H, BLF257721H, BLF257722H, BLF257723H, BLF257726H, BLF257729H, BLF257732H, BLF257734H, BLF257735H, BLF257736H, BLF257737H, BLF257738H, BLF257740H, BLF257741H, BLF257742H, BLF257743H, BLF257744H, BLF257749H, BLF257752H, BLF257111H, BLF258105H, BLF258125H, BLF257321H, BLF257702H, BLF258002H, BLF258003H, BLF258004H, BLF258223H, BLF257278H, BLF256765H, BLF256923H, BLF257010H, BLF257187H, BLF257282H, BLF257406H, BLF257439H, BLF257492H, BLF257584H, BLF257995H, BLF257996H, BLF258248H, BLF257044H, BLF257444H, BLF257485H, BLF257991H, BLF256949H, BLF256966H, BLF257072H, BLF257087H, BLF257312H, BLF257344H, BLF257488H, BLF257505H, BLF257672H, BLF257771H, BLF257804H, BLF257847H, BLF257855H, BLF257981H, BLF258023H, BLF258034H, BLF258233H, BLF258255H, BLF258275H, BLF258290H, BLF257217H, BLF258264H, BLF257073H, BLF257067H, BLF257486H, BLF257869H, BLF257211H, BLF257445H, BLF257469H, BLF257484H, BLF257544H, BLF257635H, BLF257667H, BLF257670H, BLF257848H, BLF257930H, BLF257938H, BLF258047H, BLF258054H, BLF258092H, BLF258128H, BLF258188H, BLF258272H, BLF258287H, BLF258164H, BLF258046H, BLF257050H, BLF257334H, BLF258167H, BLF257964H, BLF258127H, BLF257534H, BLF257845H, BLF257555H, BLF257908H, BLF258137H, BLF258297H, BLF257186H, BLF257330H, BLF257159H, BLF257905H, BLF258049H, BLF257481H, BLF256951H, BLF257066H, BLF257626H, BLF257333H, BLF257579H, BLF257594H, BLF256982H, BLF256925H, BLF257623H, BLF256856H, BLF258001H, BLF257022H, BLF257228H, BLF257920H, BLF256974H, BLF257109H, BLF257364H, BLF257500H, BLF257622H, BLF257763H, BLF257922H, BLF257955H, BLF258017H, BLF258177H, BLF256850H, BLF257446H, BLF257928H, BLF258050H, BLF258064H, BLF258179H, BLF256863H, BLF256790H, BLF257179H, BLF257778H, BLF257277H, BLF257954H, BLF257148H, BLF257296H, BLF258208H, BLF257465H, BLF257493H, BLF257590H, BLF257717H, BLF257796H, BLF257799H, BLF258120H, BLF258259H, BLF258281H, BLF258283H, BLF256868H, BLF257026H, BLF257673H, BLF257082H, BLF258249H, BLF257428H, BLF257252H, BLF257255H, BLF257519H, BLF257533H, BLF257557H, BLF258015H, BLF258225H, BLF257463H, BLF257123H, BLF257374H, BLF257451H, BLF257774H, BLF258231H, BLF257052H, BLF257247H, BLF258262H, BLF258263H; GTIN 00763000059545, Lot Serial Numbers: BLF600587S, BLF600701S, BLF600748S, BLF600569S, BLF600439S, BLF600140S, BLF600562S, BLF600468S, BLF600176S, BLF600313S, BLF600811S, BLF600555S, BLF600533S, BLF600535S, BLF600266S, BLF600722S, BLF600277S, BLF600623S, BLF600227S, BLF600574S, BLF600680S, BLF600240S, BLF600259S, BLF600263S, BLF600349S, BLF600508S, BLF600528S, BLF600847S, BLF600171S, BLF600092S, BLF600405S, BLF600321S, BLF600145S, BLF600049S, BLF600322S, BLF600456S, BLF600411S, BLF600124S, BLF600486S, BLF600341S, BLF600391S, BLF600532S, BLF600230S, BLF600130S, BLF600487S, BLF600505S, BLF600856S, BLF600730S, BLF600422S, BLF600446S, BLF600785S, BLF600149S, BLF600242S, BLF600615S, BLF600243S, BLF600015S, BLF600632S, BLF600032S, BLF600137S, BLF600198S, BLF600212S, BLF600514S, BLF600344S, BLF600593S, BLF600153S, BLF600275S, BLF600462S, BLF600112S, BLF600443S, BLF600450S, BLF600482S, BLF600510S, BLF600592S, BLF600578S, BLF600244S, BLF600814S, BLF600575S, BLF600036S, BLF600044S, BLF600352S, BLF600492S, BLF600757S, BLF600285S, BLF600698S, BLF600624S, BLF600626S, BLF600031S, BLF600126S, BLF600234S, BLF600824S, BLF600795S, BLF600115S, BLF600116S, BLF600117S, BLF600118S, BLF600122S, BLF600123S, BLF600431S, BLF600437S, BLF600861S, BLF600862S, BLF600459S, BLF600460S, BLF600209S, BLF600301S, BLF600581S, BLF600586S, BLF600858S, BLF600016S, BLF600141S, BLF600220S, BLF600493S, BLF600544S, BLF600163S, BLF600169S, BLF600187S, BLF600020S, BLF600021S, BLF600396S, BLF600714S, BLF600682S, BLF600694S, BLF600458S, BLF600480S, BLF600111S, BLF600387S, BLF600831S, BLF600135S, BLF600619S, BLF600697S, BLF600394S, BLF600783S, BLF600736S, BLF600752S, BLF600202S, BLF600204S, BLF600316S, BLF600445S, BLF600649S, BLF600513S, BLF600346S, BLF600183S, BLF600403S, BLF600185S, BLF600131S, BLF600099S, BLF600677S, BLF600678S, BLF600229S, 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BLF600495S, BLF600774S, BLF600364S, BLF600369S, BLF600490S, BLF600686S, BLF600718S, BLF600599S, BLF600603S, BLF600601S, BLF600527S, BLF600154S, BLF600427S, BLF600471S, BLF600691S, BLF600173S, BLF600170S, BLF600178S, BLF600631S, BLF600712S, BLF600404S, BLF600367S, BLF600194S, BLF600687S, BLF600190S, BLF600160S, BLF600030S, BLF600090S, BLF600640S, BLF600457S, BLF600278S, BLF600261S, BLF600659S, BLF600332S, BLF600716S, BLF600848S, BLF600325S, BLF600416S, BLF600543S, BLF600594S, BLF600715S, BLF600402S, BLF600488S, BLF600121S, BLF600253S, BLF600248S, BLF600255S, BLF600579S, BLF600548S, BLF600348S, BLF600023S, BLF600024S, BLF600025S, BLF600026S, BLF600027S, BLF600028S, BLF600033S, BLF600034S, BLF600057S, BLF600058S, BLF600059S, BLF600060S, BLF600061S, BLF600062S, BLF600064S, BLF600067S, BLF600078S, BLF600080S, BLF600082S, BLF600763S |
| Center Classification Date | 20230616 |
| Recall Initiation Date | 20230510 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
| Similar To |