Class 1 Device Recall medtronic

• Date Initiated by Firm: May 10, 2023
• Date Posted: June 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1761-2023
• Recall Event ID: 92328
• PMA Number: P010031S550
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
• Product: CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators
• Code Information: GTIN 00643169837690, Lot Serial Numbers: RPV203851H, RPV203879H, RPV204192H, RPV204308H, RPV205279H, RPV205423H, RPV205665H, RPV205443H, RPV205510H, RPV204476H, RPV205107H, RPV204152H, RPV204326H, RPV204327H, RPV204329H, RPV203937H, RPV204831H, RPV204911H, RPV205343H, RPV205351H, RPV205497H, RPV205762H, RPV205763H, RPV205785H, RPV203840H, RPV204908H, RPV205661H, RPV203773H, RPV203795H, RPV203808H, RPV204568H, RPV205383H, RPV205713H, RPV205312H, RPV205849H, RPV204239H, RPV205251H, RPV203909H, RPV204821H, RPV205370H, RPV205812H, RPV205832H, RPV205093H, RPV204730H, RPV204741H, RPV204553H, RPV203983H, RPV205414H, RPV205597H, RPV205682H, RPV205541H, RPV204597H, RPV204711H, RPV205219H, RPV205645H, RPV205215H, RPV205056H, RPV203988H, RPV204130H, RPV204198H, RPV204610H, RPV205672H, RPV205843H, RPV205358H, RPV205484H, RPV205614H, RPV204042H, RPV204393H, RPV204418H, RPV204768H, RPV205338H, RPV205636H, RPV204270H, RPV205806H, RPV204735H, RPV204785H, RPV204806H, RPV205115H, RPV205117H, RPV205118H, RPV205120H, RPV205257H, RPV205259H, RPV205320H, RPV205337H, RPV205356H, RPV205384H, RPV205436H, RPV205442H, RPV205593H, RPV205756H, RPV205775H, RPV205811H, RPV203905H, RPV204228H, RPV204229H, RPV204681H, RPV204682H, RPV204959H, RPV205211H, RPV205288H, RPV205299H, RPV204872H, RPV203738H, RPV203780H, RPV203783H, RPV203787H, RPV203861H, RPV204026H, RPV204037H, RPV204128H, RPV204527H, RPV204535H, RPV204929H, RPV204930H, RPV204938H, RPV204941H, RPV204942H, RPV204950H, RPV204952H, RPV205372H, RPV205426H, RPV205430H, RPV205438H, RPV205787H, RPV205817H, RPV205835H, RPV204269H, RPV204612H, RPV205032H, RPV205086H, RPV205223H, RPV205252H, RPV204752H, RPV205185H, RPV205292H, RPV205534H, RPV205615H, RPV205638H, RPV205748H, RPV204015H, RPV204855H, RPV205220H, RPV205317H, RPV205757H, RPV205802H, RPV205826H, RPV203862H, RPV204890H, RPV205389H, RPV205407H, RPV204189H, RPV204201H, RPV204428H, RPV204589H, RPV204858H, RPV204894H, RPV205808H, RPV204755H, RPV205065H, RPV205385H, RPV204055H, RPV204803H, RPV204849H, RPV204882H, RPV205377H, RPV205397H, RPV205751H, RPV204070H, RPV204348H, RPV204760H, RPV203860H, RPV204099H, RPV204974H, RPV205562H, RPV205804H, RPV205693H, RPV203914H, RPV204400H, RPV203944H, RPV204016H, RPV204163H, RPV204480H, RPV205133H, RPV205368H, RPV205688H, RPV204191H, RPV204816H, RPV205052H, RPV205148H, RPV205194H, RPV205203H, RPV205277H, RPV205639H, RPV205714H, RPV204008H, RPV205113H, RPV204147H, RPV204242H, RPV205108H, RPV205369H, RPV204315H, RPV205189H, RPV204131H, RPV203994H, RPV204261H, RPV205602H, RPV205764H, RPV204900H, RPV205458H, RPV204072H, RPV204273H, RPV204370H, RPV205101H, RPV205030H, RPV205591H, RPV204562H, RPV204692H, RPV205140H, RPV205160H, RPV205461H, RPV205677H, RPV205841H, RPV204426H, RPV204886H, RPV204968H, RPV204972H, RPV205177H, RPV205418H, RPV204514H, RPV205218H, RPV205522H, RPV204004H, RPV204934H, RPV205598H, RPV205094H, RPV205410H, RPV204098H, RPV204235H, RPV204236H, RPV204249H, RPV204253H, RPV204258H, RPV204292H, RPV205630H, RPV205686H, RPV205858H, RPV204729H, RPV204892H, RPV205043H, RPV205044H, RPV205394H, RPV205403H, RPV205581H, RPV205707H, RPV204303H, RPV204305H, RPV204328H, RPV204649H, RPV205231H, RPV205715H, RPV205776H, RPV203734H, RPV204146H, RPV204520H, RPV204545H, RPV204611H, RPV204739H, RPV204940H, RPV204966H, RPV205026H, RPV205224H, RPV205280H, RPV205286H, RPV205464H, RPV205687H, RPV205689H, RPV205725H, RPV203748H, RPV204765H, RPV204955H, RPV205431H, RPV204206H, RPV204275H, RPV204325H, RPV204919H, RPV203904H, RPV204549H, RPV205049H, RPV205114H, RPV205427H, RPV205537H, RPV205752H, RPV204006H, RPV204566H, RPV204783H, RPV204875H, RPV204913H, RPV205090H, RPV205186H, RPV205197H, RPV205198H, RPV205204H, RPV205226H, RPV205334H, RPV205468H, RPV205490H, RPV205173H, RPV204139H, RPV204630H, RPV204773H, RPV204815H, RPV204879H, RPV204965H, RPV205784H, RPV203991H, RPV204909H, RPV205018H, RPV205228H, RPV205600H, RPV205778H, RPV205862H, RPV203813H, RPV204678H, RPV204748H, RPV204885H, RPV204918H, RPV205057H, RPV205208H, RPV205298H, RPV205478H, RPV205582H, RPV205629H, RPV205684H, RPV205718H, RPV204312H, RPV204401H, RPV205330H, RPV205331H, RPV203755H, RPV204279H, RPV203081H, RPV205362H, RPV203969H, RPV205446H, RPV205788H, RPV204486H, RPV205289H, RPV205378H, RPV205781H, RPV205852H, RPV203762H, RPV203779H, RPV203781H, RPV205075H, RPV205766H, RPV203995H, RPV204231H, RPV204376H, RPV204799H, RPV205577H, RPV205261H, RPV205134H, RPV204469H, RPV204639H, RPV204644H, RPV204813H, RPV205281H, RPV205704H, RPV205705H, RPV204433H, RPV205045H, RPV204283H, RPV204764H, RPV204638H, RPV204789H, RPV205116H, RPV205136H, RPV205190H, RPV205210H, RPV205225H, RPV205395H, RPV205411H, RPV205551H, RPV205712H, RPV205818H, RPV203082H, RPV204020H, RPV205283H, RPV205412H, RPV205848H, RPV204035H, RPV205103H, RPV205373H, RPV205590H, RPV205415H, RPV205528H, RPV203741H, RPV204576H, RPV205250H, RPV205472H, RPV205640H, RPV205754H, RPV205193H, RPV205374H, RPV203774H, RPV204119H, RPV204377H, RPV204840H, RPV204967H, RPV205054H, RPV205060H, RPV203979H, RPV204127H, RPV203933H, RPV204005H, RPV204062H, RPV204248H, RPV204559H, RPV204943H, RPV205062H, RPV205520H, RPV203907H, RPV204077H, RPV205184H, RPV205318H, RPV205398H, RPV205417H, RPV204388H, RPV205306H, RPV204903H, RPV205102H, RPV204033H, RPV204112H, RPV205409H, RPV204058H, RPV205291H, RPV204550H, RPV204818H, RPV203939H, RPV203981H, RPV204124H, RPV204180H, RPV204819H, RPV205209H, RPV205670H, RPV205701H, RPV205856H, RPV204445H, RPV204039H, RPV204624H, RPV204698H, RPV205563H, RPV203894H, RPV203896H, RPV204114H, RPV204316H, RPV204282H, RPV204600H, RPV203764H, RPV204274H, RPV205786H, RPV204159H, RPV204861H, RPV205024H, RPV205138H, RPV205404H, RPV205539H, RPV205540H, RPV204295H, RPV204537H, RPV204837H, RPV205088H, RPV205207H, RPV204551H, RPV204548H, RPV205069H, RPV205097H, RPV205232H, RPV203736H, RPV203814H, RPV204509H, RPV205569H, RPV203953H, RPV204001H, RPV204034H, RPV205064H, RPV205521H, RPV204177H, RPV204299H, RPV204331H, RPV204344H, RPV205618H, RPV205859H, RPV204775H, RPV203817H, RPV205604H, RPV204654H, RPV205850H, RPV205429H, RPV205789H, RPV203875H, RPV203928H, RPV204111H, RPV204170H, RPV204707H, RPV204414H, RPV205042H, RPV203756H, RPV205353H, RPV204373H, RPV204011H, RPV204384H, RPV205535H, RPV203800H, RPV205278H, RPV205530H, RPV205720H, RPV205750H, RPV205810H, RPV204100H, RPV203842H, RPV205699H, RPV205700H, RPV205675H, RPV205641H, RPV205552H, RPV204153H, RPV204383H, RPV204845H, RPV205123H, RPV205561H, RPV205656H, RPV203949H, RPV204056H, RPV204202H, RPV204423H, RPV204728H, RPV205244H, RPV205350H, RPV205475H, RPV205476H, RPV205527H, RPV205543H, RPV205589H, RPV205631H, RPV205801H, RPV205816H, RPV203801H, RPV203923H, RPV204606H, RPV204769H, RPV203932H, RPV204396H, RPV204511H, RPV204047H, RPV204543H, RPV204763H, RPV205634H, RPV203775H, RPV204429H, RPV204538H, RPV205080H, RPV205282H, RPV205473H, RPV205572H, RPV205698H, RPV205783H, RPV203720H, RPV204298H, RPV205769H, RPV204989H, RPV204992H, RPV204998H, RPV204999H, RPV205000H, RPV205009H, RPV205010H, RPV205011H, RPV204880H, RPV204608H, RPV204216H, RPV204310H, RPV205129H, RPV205827H, RPV205122H, RPV205771H, RPV204598H, RPV205734H, RPV204794H, RPV204884H, RPV205333H, RPV204916H, RPV204136H, RPV203867H, RPV203868H, RPV204071H, RPV204166H, RPV204181H, RPV204182H, RPV204343H, RPV204371H, RPV204521H, RPV204522H, RPV204524H, RPV205421H, RPV205467H, RPV205606H, RPV205616H, RPV204041H, RPV204737H, RPV203785H, RPV204554H, RPV205557H, RPV205583H, RPV205599H, RPV205722H, RPV205747H, RPV205089H, RPV205391H, RPV204658H, RPV204790H, RPV204731H, RPV205121H, RPV205424H, RPV205637H, RPV204973H, RPV205130H, RPV205402H, RPV205420H, RPV205571H, RPV204304H, RPV204363H, RPV203921H, RPV205733H, RPV205584H, RPV204165H, RPV204381H, RPV204415H, RPV204564H, RPV204565H, RPV204801H, RPV204917H, RPV204970H, RPV205033H, RPV205150H, RPV205730H, RPV204140H, RPV204321H, RPV204366H, RPV204560H, RPV204734H, RPV205023H, RPV205046H, RPV205106H, RPV205175H, RPV205274H, RPV205285H, RPV205314H, RPV205434H, RPV205502H, RPV205034H, RPV205406H, RPV203080H, RPV204690H, RPV204902H, RPV205055H, RPV205388H, RPV205466H, RPV204061H, RPV205191H, RPV204695H, RPV205486H, RPV203754H, RPV203767H, RPV203769H, RPV203778H, RPV203796H, RPV203804H, RPV203824H, RPV203892H, RPV203900H, RPV204240H, RPV204322H, RPV204351H, RPV204357H, RPV204358H, RPV204359H, RPV204361H, RPV204364H, RPV204365H, RPV204453H, RPV204703H, RPV204727H, RPV204859H, RPV204860H, RPV204866H, RPV204867H, RPV205029H, RPV205078H, RPV205081H, RPV205179H, RPV205181H, RPV205187H, RPV205256H, RPV205264H, RPV205268H, RPV205456H, RPV205525H, RPV205547H, RPV205549H, RPV205632H, RPV205726H, RPV205780H, RPV205702H, RPV204787H, RPV205664H, RPV205492H, RPV205074H, RPV204888H, RPV204704H, RPV204291H, RPV205405H, RPV203951H, RPV203996H, RPV204073H, RPV204245H, RPV204278H, RPV204288H, RPV204473H, RPV204591H, RPV204687H, RPV204712H, RPV204744H, RPV204751H, RPV204839H, RPV205165H, RPV205170H, RPV205171H, RPV205172H, RPV205440H, RPV205450H, RPV205454H, RPV205482H, RPV205483H, RPV205538H, RPV205635H, RPV205650H, RPV205681H, RPV205683H, RPV205690H, RPV205792H, RPV205853H, RPV205864H, RPV204780H, RPV204057H, RPV204563H, RPV204820H, RPV205721H, RPV205139H, RPV205460H, RPV205621H, RPV204795H, RPV205400H, RPV204635H, RPV204014H, RPV205296H, RPV205308H, RPV205807H, RPV204324H, RPV204540H, RPV205649H, RPV204804H, RPV205125H, RPV205428H, RPV205828H, RPV204010H, RPV204379H, RPV204394H, RPV204946H, RPV204976H, RPV205233H, RPV204850H, RPV205758H, RPV205825H, RPV205619H, RPV205761H, RPV203936H, RPV204579H, RPV204641H, RPV205083H, RPV205212H, RPV205213H, RPV205319H, RPV205519H, RPV205536H, RPV205773H, RPV205782H, RPV205822H, RPV205829H, RPV204250H, RPV204853H, RPV205112H, RPV205128H, RPV204416H, RPV204756H, RPV205017H, RPV205156H, RPV205393H, RPV205151H, RPV203934H, RPV203732H, RPV203870H, RPV203871H, RPV204108H, RPV204157H, RPV204162H, RPV204167H, RPV204207H, RPV204226H, RPV204332H, RPV204336H, RPV204338H, RPV204340H, RPV204436H, RPV204477H, RPV204506H, RPV204590H, RPV204652H, RPV204691H, RPV204693H, RPV204700H, RPV204701H, RPV204718H, RPV204745H, RPV204753H, RPV204759H, RPV204761H, RPV204843H, RPV204874H, RPV204926H, RPV204995H, RPV204996H, RPV205147H, RPV205161H, RPV205195H, RPV205205H, RPV205227H, RPV205240H, RPV205242H, RPV205243H, RPV205255H, RPV205265H, RPV205324H, RPV205366H, RPV205367H, RPV205462H, RPV205470H, RPV205496H, RPV205663H, RPV205667H, RPV205668H, RPV205669H, RPV205759H, RPV205772H, RPV205805H, RPV203735H, RPV204222H, RPV204852H, RPV205799H, RPV203737H, RPV203835H, RPV203837H, RPV204103H, RPV204104H, RPV204212H, RPV204219H, RPV204221H, RPV204405H, RPV204410H, RPV204449H, RPV204478H, RPV204479H, RPV204481H, RPV204482H, RPV204485H, RPV204489H, RPV204666H, RPV204684H, RPV204686H, RPV205082H, RPV205153H, RPV205166H, RPV205200H, RPV205249H, RPV205328H, RPV205329H, RPV205349H, RPV205504H, RPV205507H, RPV205508H, RPV205516H, RPV205694H, RPV205739H, RPV205753H, RPV205770H, RPV204017H, RPV205455H, RPV204049H, RPV204195H, RPV204197H, RPV204688H, RPV205836H, RPV204065H, RPV204372H, RPV204395H, RPV205071H, RPV205444H, RPV203966H, RPV203967H, RPV203985H, RPV204342H, RPV204346H, RPV204647H, RPV204651H, RPV204668H, RPV204676H, RPV204738H, RPV204878H, RPV204978H, RPV204980H, RPV205448H, RPV205451H, RPV205452H, RPV205652H, RPV205658H, RPV205709H, RPV205723H, RPV205737H, RPV205710H, RPV203931H, RPV204243H, RPV204706H, RPV204173H, RPV205144H, RPV204009H, RPV204225H, RPV204546H, RPV204733H, RPV205048H, RPV205217H, RPV205342H, RPV205560H, RPV204354H, RPV204650H, RPV203888H, RPV204013H, RPV204857H, RPV205310H, RPV205578H, RPV205736H, RPV205767H, RPV204969H, RPV205131H, RPV205857H, RPV205624H, RPV203948H, RPV204092H, RPV204150H, RPV204223H, RPV204285H, RPV204822H, RPV204924H, RPV204953H, RPV204390H, RPV205305H, RPV205613H, RPV203999H, RPV204319H, RPV204702H, RPV204710H, RPV204713H, RPV204714H, RPV204715H, RPV205196H, RPV205199H, RPV205487H, RPV205524H, RPV205526H, RPV205842H, RPV204318H, RPV204603H, RPV204369H, RPV204375H, RPV204025H, RPV204137H, RPV204791H, RPV204939H, RPV205311H, RPV205612H, RPV204313H, RPV205824H, RPV203917H, RPV203918H, RPV205222H, RPV205523H, RPV205576H, RPV205821H, RPV203947H, RPV204296H, RPV205126H, RPV205512H, RPV204491H, RPV204841H, RPV204851H, RPV205216H, RPV205332H, RPV205355H, RPV205357H, RPV204040H, RPV205432H, RPV205413H, RPV204897H, RPV204314H, RPV205653H, RPV204570H, RPV203883H, RPV204301H, RPV205127H, RPV205152H, RPV205361H, RPV205371H, RPV204135H, RPV205202H, RPV205345H, RPV203945H, RPV204012H, RPV205095H, RPV205673H, RPV204097H, RPV205575H, RPV204631H, RPV204277H, RPV205648H, RPV204160H, RPV205579H, RPV205269H, RPV203739H, RPV204030H, RPV204297H, RPV204828H, RPV204971H, RPV205671H, RPV205740H, RPV205760H, RPV205273H, RPV205586H, RPV205601H, RPV205666H, RPV203721H, RPV204767H, RPV205077H, RPV205322H, RPV205453H, RPV205768H, RPV205728H, RPV205596H, RPV205567H, RPV205580H, RPV203926H, RPV204132H, RPV204190H, RPV204205H, RPV204208H, RPV204267H, RPV204293H, RPV204932H, RPV205861H, RPV204302H, RPV204068H, RPV204685H, RPV204778H, RPV205316H, RPV205719H, RPV204060H, RPV204544H, RPV205013H, RPV205015H, RPV205437H, RPV204120H, RPV204782H, RPV204847H, RPV205463H, RPV205518H, RPV204810H, RPV204832H, RPV204220H, RPV205565H, RPV204596H, RPV204987H, RPV205037H, RPV205085H, RPV205633H, RPV205724H, RPV203799H, RPV204050H, RPV204187H, RPV204412H, RPV204547H, RPV205105H, RPV205254H, RPV205258H, RPV204505H, RPV204746H, RPV205092H, RPV204539H, RPV205617H, RPV205865H, RPV204227H, RPV204922H, RPV203726H, RPV203805H, RPV204233H, RPV204627H, RPV204719H, RPV204877H, RPV204935H, RPV204937H, RPV204964H, RPV205099H, RPV205110H, RPV205149H, RPV205206H, RPV205267H, RPV205379H, RPV205573H, RPV205595H, RPV205820H, RPV204925H, RPV203890H, RPV204286H, RPV204431H, RPV204179H, RPV204262H, RPV203938H, RPV204066H, RPV204199H, RPV204259H, RPV204601H, RPV203776H, RPV205777H, RPV204824H, RPV203992H, RPV204625H, RPV205236H, RPV205499H, RPV205500H, RPV205708H, RPV205729H, RPV205831H, RPV203852H, RPV204063H, RPV204095H, RPV204750H, RPV204817H, RPV205793H, RPV205794H, RPV204413H, RPV205514H, RPV205531H, RPV204883H, RPV204979H, RPV205517H, RPV205588H, RPV203806H, RPV203889H, RPV204217H, RPV204391H, RPV204556H, RPV204696H, RPV205546H, RPV205625H, RPV204541H, RPV204149H, RPV204374H, RPV204754H, RPV205016H, RPV203913H, RPV204811H, RPV205359H, RPV204501H, RPV203885H, RPV205399H, RPV204583H, RPV205797H, RPV204133H, RPV204512H, RPV204178H, RPV204349H, RPV205297H, RPV205433H, RPV205568H, RPV205087H, RPV205313H, RPV205335H, RPV205697H, RPV205743H, RPV205058H, RPV205321H, RPV205676H, RPV205735H, RPV204031H, RPV204758H, RPV205642H, RPV205435H, RPV203887H, RPV204019H, RPV204743H, RPV204805H, RPV204807H, RPV204933H, RPV205155H, RPV205214H, RPV205300H, RPV205344H, RPV205364H, RPV205790H, RPV205813H, RPV205304H, RPV205745H, RPV205678H, RPV205679H, RPV204000H, RPV205295H, RPV205585H, RPV205401H, RPV205741H, RPV205554H, RPV205706H, RPV203733H, RPV203743H, RPV203751H, RPV203757H, RPV203759H, RPV204247H, RPV204848H, RPV205020H, RPV205059H, RPV205188H, RPV205266H, RPV205201H, RPV205363H, RPV204809H, RPV204796H, RPV204901H, RPV205542H, RPV205727H, RPV204812H, RPV203898H, RPV204842H, RPV203821H, RPV205163H, RPV203925H, RPV204168H, RPV204823H, RPV204232H, RPV204263H, RPV204264H, RPV204335H, RPV204561H, RPV204581H, RPV204856H, RPV205396H, RPV205674H, RPV205795H, RPV205863H, RPV205594H, RPV205605H, RPV205839H, RPV205646H, RPV205229H, RPV205230H, RPV203727H, RPV203728H, RPV203731H, RPV203771H, RPV203786H, RPV203789H, RPV203791H, RPV203797H, RPV203816H, RPV203826H, RPV203827H, RPV203828H, RPV203830H, RPV203831H, RPV203832H, RPV203833H, RPV203834H, RPV203838H, RPV203841H, RPV203846H, RPV203849H, RPV203850H, RPV203859H, RPV203864H, RPV203866H, RPV203869H, RPV203872H, RPV203873H, RPV203874H, RPV203876H, RPV203878H, RPV203881H, RPV203919H, RPV203943H, RPV203957H, RPV203960H, RPV203961H, RPV203970H, RPV203971H, RPV203975H, RPV203977H, RPV204028H, RPV204036H, RPV204048H, RPV204053H, RPV204074H, RPV204075H, RPV204076H, RPV204079H, RPV204080H, RPV204081H, RPV204082H, RPV204084H, RPV204085H, RPV204087H, RPV204088H, RPV204090H, RPV204093H, RPV204252H, RPV204350H, RPV204352H, RPV204406H, RPV204407H, RPV204408H, RPV204420H, RPV204422H, RPV204424H, RPV204437H, RPV204444H, RPV204446H, RPV204448H, RPV204451H, RPV204452H, RPV204454H, RPV204456H, RPV204457H, RPV204460H, RPV204461H, RPV204462H, RPV204464H, RPV204465H, RPV204466H, RPV204467H, RPV204472H, RPV204474H, RPV204475H, RPV204484H, RPV204487H, RPV204488H, RPV204490H, RPV204493H, RPV204495H, RPV204496H, RPV204498H, RPV204499H, RPV204500H, RPV204503H, RPV204515H, RPV204528H, RPV204530H, RPV204577H, RPV204584H, RPV204586H, RPV204587H, RPV204588H, RPV204659H, RPV204661H, RPV204662H, RPV204667H, RPV204670H, RPV204671H, RPV204674H, RPV204679H, RPV204680H, RPV204694H, RPV204697H, RPV204740H, RPV204762H, RPV204792H, RPV204793H, RPV204802H, RPV204844H, RPV204846H, RPV204864H, RPV204865H, RPV204876H, RPV204887H, RPV204907H, RPV204921H, RPV204954H, RPV204981H, RPV204983H, RPV204990H, RPV204993H, RPV204997H, RPV205001H, RPV205003H, RPV205004H, RPV205005H, RPV205006H, RPV205007H, RPV205012H, RPV205019H, RPV205021H, RPV205022H, RPV205031H, RPV205145H, RPV205159H, RPV205164H, RPV205221H, RPV205237H, RPV205260H, RPV205263H, RPV205271H, RPV205284H, RPV205290H, RPV205302H, RPV205339H, RPV205340H, RPV205347H, RPV205830H; GTIN 00763000059606, Lot Serial Numbers: RPV601936S, RPV601530S, RPV601840S, RPV601064S, RPV601250S, RPV600322S, RPV600448S, RPV600532S, RPV600706S, RPV600790S, RPV600829S, RPV600983S, RPV601276S, RPV600436S, RPV600563S, RPV601146S, RPV601406S, RPV601430S, RPV601518S, RPV601549S, RPV600617S, RPV600650S, RPV601102S, RPV601147S, RPV601667S, RPV601767S, RPV601213S, RPV601701S, RPV601702S, RPV601527S, RPV601546S, RPV601601S, RPV601624S, RPV601686S, RPV601937S, RPV600027S, RPV600739S, RPV601275S, RPV601314S, RPV601388S, RPV601957S, RPV600272S, RPV600039S, RPV600222S, RPV600343S, RPV600353S, RPV600638S, RPV600746S, RPV601294S, RPV601193S, RPV600701S, RPV600703S, RPV600182S, RPV600959S, RPV601403S, RPV601347S, RPV601320S, RPV601370S, RPV600258S, RPV600755S, RPV600833S, RPV601439S, RPV601750S, RPV601762S, RPV600683S, RPV601202S, RPV600993S, RPV601559S, RPV600789S, RPV601094S, RPV600984S, RPV601768S, RPV601779S, RPV601570S, RPV600883S, RPV600425S, RPV600938S, RPV600053S, RPV601529S, RPV601836S, RPV600928S, RPV601117S, RPV601363S, RPV601581S, RPV601240S, RPV600083S, RPV600201S, RPV600117S, RPV600760S, RPV600780S, RPV601008S, RPV601095S, RPV600456S, RPV600671S, RPV600680S, RPV600016S, RPV600017S, RPV600018S, RPV600019S, RPV600022S, RPV600023S, RPV600024S, RPV600147S, RPV600148S, RPV600151S, RPV600149S, RPV600634S, RPV601483S, RPV600657S, RPV600704S, RPV600749S, RPV600879S, RPV601216S, RPV601291S, RPV600080S, RPV601579S, RPV601583S, RPV600752S, RPV601838S, RPV600592S, RPV601419S, RPV601429S, RPV601456S, RPV601506S, RPV601580S, RPV601582S, RPV601672S, RPV601673S, RPV601710S, RPV601829S, RPV601830S, RPV601863S, RPV600266S, RPV600415S, RPV600513S, RPV600564S, RPV600621S, RPV600631S, RPV600742S, RPV600744S, RPV600917S, RPV600947S, RPV600958S, RPV600965S, RPV600996S, RPV601023S, RPV601028S, RPV601051S, RPV601069S, RPV601166S, RPV601167S, RPV601217S, RPV601067S, RPV601424S, RPV600470S, RPV600816S, RPV601329S, RPV600771S, RPV601730S, RPV601867S, RPV601868S, RPV601883S, RPV601923S, RPV600318S, RPV600369S, RPV600373S, RPV600379S, RPV600397S, RPV600407S, RPV600531S, RPV600644S, RPV600655S, RPV600667S, RPV600782S, RPV600804S, RPV600834S, RPV600838S, RPV600863S, RPV600872S, RPV600878S, RPV600922S, RPV600924S, RPV600927S, RPV600929S, RPV600952S, RPV601056S, RPV601134S, RPV601181S, RPV601200S, RPV601272S, RPV601325S, RPV600199S, RPV600666S, RPV601543S, RPV601853S, RPV600326S, RPV600451S, RPV600524S, RPV600537S, RPV600663S, RPV600670S, RPV600684S, RPV600685S, RPV600862S, RPV600918S, RPV601238S, RPV601247S, RPV600462S, RPV600601S, RPV600898S, RPV601206S, RPV601600S, RPV601657S, RPV601658S, RPV601809S, RPV600619S, RPV601163S, RPV600229S, RPV600237S, RPV600294S, RPV600481S, RPV600546S, RPV600732S, RPV601176S, RPV600489S, RPV600641S, RPV600982S, RPV601495S, RPV600611S, RPV601281S, RPV600475S, RPV601544S, RPV600372S, RPV601164S, RPV601303S, RPV601298S, RPV601426S, RPV601611S, RPV600544S, RPV601279S, RPV601629S, RPV601654S, RPV600764S, RPV600694S, RPV601512S, RPV600488S, RPV600054S, RPV600175S, RPV600196S, RPV600289S, RPV601539S, RPV601747S, RPV600464S, RPV601773S, RPV600317S, RPV600856S, RPV601136S, RPV601150S, RPV601180S, RPV600385S, RPV600500S, RPV600246S, RPV601045S, RPV601171S, RPV601995S, RPV600600S, RPV600274S, RPV601235S, RPV601377S, RPV601652S, RPV600153S, RPV601001S, RPV601002S, RPV601446S, RPV601802S, RPV600301S, RPV600552S, RPV601138S, RPV600925S, RPV600226S, RPV600238S, RPV600505S, RPV600270S, RPV600457S, RPV601264S, RPV600244S, RPV600341S, RPV600459S, RPV600658S, RPV600676S, RPV600730S, RPV600765S, RPV600798S, RPV600812S, RPV600880S, RPV600076S, RPV600381S, RPV600439S, RPV600578S, RPV600864S, RPV600867S, RPV600886S, RPV600975S, RPV600994S, RPV601000S, RPV601032S, RPV601087S, RPV601088S, RPV601089S, RPV601090S, RPV601091S, RPV601096S, RPV601097S, RPV600420S, RPV600432S, RPV600556S, RPV601783S, RPV601649S, RPV601650S, RPV601693S, RPV601694S, RPV601858S, RPV601870S, RPV601880S, RPV600254S, RPV600533S, RPV600616S, RPV601897S, RPV601921S, RPV601922S, RPV600426S, RPV600429S, RPV600539S, RPV600681S, RPV601113S, RPV601440S, RPV601567S, RPV601053S, RPV601205S, RPV601999S, RPV601712S, RPV601713S, RPV601568S, RPV601049S, RPV601160S, RPV601311S, RPV601355S, RPV601369S, RPV600309S, RPV601743S, RPV601827S, RPV600674S, RPV600483S, RPV600484S, RPV600499S, RPV600572S, RPV600577S, RPV600769S, RPV600871S, RPV600873S, RPV600896S, RPV600897S, RPV601246S, RPV601248S, RPV601358S, RPV601359S, RPV601553S, RPV600267S, RPV600277S, RPV600502S, RPV600516S, RPV600517S, RPV600283S, RPV600290S, RPV600292S, RPV600319S, RPV600338S, RPV600344S, RPV600388S, RPV600541S, RPV600561S, RPV601684S, RPV600380S, RPV600825S, RPV600935S, RPV601317S, RPV601459S, RPV601789S, RPV601024S, RPV601101S, RPV601192S, RPV601902S, RPV601012S, RPV601630S, RPV601076S, RPV601357S, RPV601723S, RPV601427S, RPV600057S, RPV600094S, RPV600212S, RPV601450S, RPV600696S, RPV600757S, RPV600944S, RPV600037S, RPV600110S, RPV601697S, RPV601932S, RPV600542S, RPV600582S, RPV601048S, RPV601232S, RPV601372S, RPV601380S, RPV600463S, RPV600493S, RPV600518S, RPV601184S, RPV601208S, RPV600428S, RPV601079S, RPV601255S, RPV601698S, RPV601708S, RPV601846S, RPV600830S, RPV600281S, RPV601389S, RPV601479S, RPV600288S, RPV600472S, RPV600543S, RPV600559S, RPV600691S, RPV600692S, RPV600707S, RPV600726S, RPV600793S, RPV600915S, RPV601131S, RPV601257S, RPV601351S, RPV600203S, RPV600819S, RPV600520S, RPV601376S, RPV600811S, RPV601891S, RPV601269S, RPV600122S, RPV601748S, RPV601448S, RPV601455S, RPV601719S, RPV601720S, RPV601721S, RPV601399S, RPV601491S, RPV601574S, RPV601575S, RPV601625S, RPV601685S, RPV601728S, RPV601915S, RPV601968S, RPV600311S, RPV600312S, RPV600401S, RPV600471S, RPV600547S, RPV600560S, RPV600569S, RPV600570S, RPV600573S, RPV600574S, RPV600723S, RPV601054S, RPV601149S, RPV601259S, RPV601277S, RPV601366S, RPV601729S, RPV602008S, RPV600734S, RPV600784S, RPV601168S, RPV601196S, RPV601415S, RPV601487S, RPV601524S, RPV601655S, RPV601733S, RPV601811S, RPV601860S, RPV600106S, RPV600327S, RPV600411S, RPV600418S, RPV600603S, RPV600649S, RPV600810S, RPV600842S, RPV600955S, RPV601030S, RPV601153S, RPV601278S, RPV601338S, RPV601344S, RPV601374S, RPV600265S, RPV600480S, RPV600165S, RPV601472S, RPV601612S, RPV600278S, RPV600310S, RPV600362S, RPV600527S, RPV600807S, RPV600910S, RPV600916S, RPV600957S, RPV601234S, RPV601239S, RPV601266S, RPV601271S, RPV601282S, RPV600901S, RPV600095S, RPV600253S, RPV600302S, RPV601488S, RPV601523S, RPV601636S, RPV600231S, RPV600275S, RPV600321S, RPV600442S, RPV600525S, RPV600571S, RPV600632S, RPV600679S, RPV600773S, RPV600869S, RPV600981S, RPV601072S, RPV601114S, RPV601175S, RPV601306S, RPV600528S, RPV600754S, RPV600741S, RPV600750S, RPV601092S, RPV601199S, RPV600078S, RPV601135S, RPV600146S, RPV601591S, RPV600325S, RPV600860S, RPV601367S, RPV601128S, RPV600299S, RPV600368S, RPV600433S, RPV600482S, RPV600722S, RPV600763S, RPV600787S, RPV600800S, RPV600936S, RPV601242S, RPV601251S, RPV601501S, RPV600661S, RPV600989S, RPV601538S, RPV601692S, RPV600291S, RPV600410S, RPV600772S, RPV600949S, RPV601007S, RPV601154S, RPV601229S, RPV601283S, RPV600099S, RPV600167S, RPV600191S, RPV600487S, RPV600609S, RPV601428S, RPV601774S, RPV601018S, RPV600843S, RPV601119S, RPV601209S, RPV600363S, RPV600953S, RPV601083S, RPV601292S, RPV600206S, RPV600128S, RPV601780S, RPV601920S, RPV600234S, RPV600891S, RPV600894S, RPV600926S, RPV601183S, RPV601187S, RPV601343S, RPV601793S, RPV601918S, RPV601766S, RPV600729S, RPV601197S, RPV601379S, RPV601659S, RPV600195S, RPV600044S, RPV600358S, RPV600365S, RPV600507S, RPV600079S, RPV600557S, RPV600071S, RPV600693S, RPV601434S, RPV601525S, RPV601526S, RPV600690S, RPV600776S, RPV600840S, RPV601039S, RPV601350S, RPV600421S, RPV600715S, RPV601189S, RPV600259S, RPV601531S, RPV601179S, RPV600111S, RPV600870S, RPV600247S, RPV600284S, RPV600409S, RPV600449S, RPV600669S, RPV600761S, RPV600803S, RPV601471S, RPV601514S, RPV601520S, RPV601680S, RPV601682S, RPV600010S, RPV600049S, RPV600371S, RPV600378S, RPV600775S, RPV600954S, RPV601006S, RPV601057S, RPV601280S, RPV601284S, RPV601334S, RPV600708S, RPV600104S, RPV600566S, RPV600654S, RPV600967S, RPV601013S, RPV601413S, RPV601788S, RPV600795S, RPV601408S, RPV601533S, RPV601572S, RPV601727S, RPV601900S, RPV600233S, RPV600430S, RPV600568S, RPV600686S, RPV600699S, RPV600837S, RPV600930S, RPV601161S, RPV601178S, RPV601210S, RPV601253S, RPV600888S, RPV600351S, RPV600461S, RPV600737S, RPV601460S, RPV600213S, RPV600904S, RPV600687S, RPV600831S, RPV600406S, RPV600522S, RPV600695S, RPV600698S, RPV600712S, RPV600467S, RPV601706S, RPV600446S, RPV600452S, RPV601034S, RPV601671S, RPV601777S, RPV601316S, RPV600271S, RPV600465S, RPV600590S, RPV600758S, RPV601346S, RPV600728S, RPV601236S, RPV601420S, RPV601577S, RPV601578S, RPV601052S, RPV601882S, RPV601496S, RPV601603S, RPV601690S, RPV600785S, RPV600059S, RPV600144S, RPV600276S, RPV600387S, RPV601417S, RPV601564S, RPV601598S, RPV601626S, RPV601645S, RPV600262S, RPV600315S, RPV600331S, RPV600738S, RPV600801S, RPV600963S, RPV601065S, RPV601237S, RPV601263S, RPV601662S, RPV601842S, RPV601186S, RPV600131S, RPV601640S, RPV601850S, RPV600116S, RPV600194S, RPV600374S, RPV600853S, RPV601080S, RPV601258S, RPV601207S, RPV600077S, RPV600109S, RPV601405S, RPV601503S, RPV600248S, RPV600859S, RPV600998S, RPV601078S, RPV600105S, RPV600091S, RPV600361S, RPV600490S, RPV600529S, RPV600799S, RPV600823S, RPV601063S, RPV600788S, RPV600792S, RPV601349S, RPV600045S, RPV601447S, RPV601552S, RPV601566S, RPV601668S, RPV600678S, RPV601270S, RPV601333S, 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RPV600796S, RPV601716S, RPV600850S, RPV601714S, RPV601394S, RPV601504S, RPV600295S, RPV600664S, RPV600711S, RPV600911S, RPV601452S, RPV601071S, RPV600268S, RPV601517S, RPV601616S, RPV601617S, RPV601818S, RPV601873S, RPV601879S, RPV600241S, RPV600293S, RPV600350S, RPV600497S, RPV600581S, RPV600584S, RPV600627S, RPV600636S, RPV600759S, RPV600770S, RPV600832S, RPV600845S, RPV600858S, RPV600892S, RPV600905S, RPV600909S, RPV601003S, RPV601005S, RPV601162S, RPV601220S, RPV601224S, RPV601336S, RPV601307S, RPV600614S, RPV601041S, RPV601457S, RPV600040S, RPV600118S, RPV601414S, RPV601814S, RPV601974S, RPV600447S, RPV600762S, RPV600852S, RPV600874S, RPV601245S, RPV601395S, RPV600224S, RPV600688S, RPV601066S, RPV601173S, RPV601177S, RPV601252S, RPV601287S, RPV600070S, RPV600580S, RPV600396S, RPV601458S, RPV601678S, RPV601737S, RPV601825S, RPV601475S, RPV600575S, RPV600583S, RPV600642S, RPV600587S, RPV601893S, RPV600526S, RPV600143S, RPV600185S, RPV600370S, RPV601356S, RPV600814S, RPV601664S, 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RPV601643S, RPV600554S, RPV600562S, RPV601027S, RPV601042S, RPV601137S, RPV601172S, RPV600264S, RPV600962S, RPV601100S, RPV600476S, RPV600751S, RPV601011S, RPV601086S, RPV601481S, RPV601724S, RPV601226S, RPV600403S, RPV601014S, RPV601828S, RPV601711S, RPV601384S, RPV601156S, RPV601031S, RPV601036S, RPV600170S, RPV600815S, RPV601884S, RPV600063S, RPV600202S, RPV600355S, RPV600786S, RPV600498S, RPV600180S, RPV600263S, RPV600665S, RPV600950S, RPV601965S, RPV600478S, RPV600540S, RPV600865S, RPV600951S, RPV601241S, RPV600217S, RPV600219S, RPV601480S, RPV601490S, RPV600356S, RPV600668S, RPV600748S, RPV600903S, RPV601004S, RPV601268S, RPV601677S, RPV601722S, RPV600820S, RPV600087S, RPV600662S, RPV600719S, RPV600555S, RPV600061S, RPV600340S, RPV600035S, RPV600088S, RPV600932S, RPV600228S, RPV600643S, RPV600286S, RPV601590S, RPV601627S, RPV601674S, RPV601121S, RPV601144S, RPV601211S, RPV601228S, RPV601256S, RPV601305S, RPV601313S, RPV601319S, RPV601335S, RPV601339S, RPV601352S, RPV601353S, 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RPV600551S, RPV601892S, RPV600408S, RPV600485S, RPV600565S, RPV600753S, RPV601718S, RPV601732S, RPV600637S, RPV600895S, RPV601221S, RPV600976S, RPV601158S, RPV601218S, RPV601223S, RPV600296S, RPV601887S, RPV600846S, RPV601103S, RPV601502S, RPV601435S, RPV601837S, RPV601866S, RPV600034S, RPV600073S, RPV601130S, RPV601373S, RPV601769S, RPV601233S, RPV601587S, RPV600966S, RPV601864S, RPV601348S, RPV600672S, RPV601628S, RPV601505S, RPV600492S, RPV601185S, RPV601331S, RPV601736S, RPV600510S, RPV600536S, RPV600705S, RPV600731S, RPV600881S, RPV600902S, RPV600956S, RPV600995S, RPV600999S, RPV601009S, RPV601188S, RPV601321S, RPV601878S, RPV601469S, RPV601565S, RPV600332S, RPV601214S, RPV600645S, RPV601286S, RPV601851S, RPV601463S, RPV601519S, RPV601111S, RPV601152S, RPV600714S, RPV600239S, RPV601554S, RPV600673S, RPV600675S, RPV601634S, RPV601908S, RPV600011S, RPV600012S, RPV600013S, RPV600162S, RPV600245S, RPV600297S, RPV600595S, RPV600735S, RPV600941S, RPV601010S, RPV600440S, RPV600979S, RPV601425S, RPV600857S, RPV601453S, RPV601454S, RPV601632S, RPV601656S, RPV601791S, RPV601815S, RPV601816S, RPV601817S, RPV601823S, RPV601824S, RPV600504S, RPV600519S, RPV601025S, RPV601081S, RPV601082S, RPV601191S, RPV601194S, RPV601299S, RPV601300S, RPV601310S, RPV601342S, RPV601859S, RPV601948S, RPV601492S, RPV600269S, RPV600964S, RPV600970S, RPV601190S, RPV601195S, RPV601493S, RPV601509S, RPV601536S, RPV601605S, RPV600282S, RPV600709S, RPV600818S, RPV600854S, RPV600900S, RPV600908S, RPV600960S, RPV600992S, RPV601035S, RPV601386S, RPV601912S, RPV601913S, RPV600882S, RPV600085S, RPV600443S, RPV601125S, RPV601485S, RPV600530S, RPV600558S, RPV600991S, RPV601274S, RPV601385S, RPV601998S, RPV601058S, RPV601265S, RPV601288S, RPV601360S, RPV601364S, RPV600334S, RPV600511S, RPV600618S, RPV601637S, RPV601761S, RPV600438S, RPV601707S, RPV601691S, RPV600875S, RPV601555S, RPV600887S, RPV601689S, RPV600339S, RPV601437S, RPV601445S, RPV601532S, RPV601944S, RPV600225S, RPV600808S, RPV600934S, RPV600943S, RPV600980S, RPV601383S, RPV600736S, RPV601398S, RPV601560S, RPV600885S, RPV601473S, RPV601537S, RPV601110S, RPV601122S, RPV601123S, RPV601847S, RPV601848S, RPV600056S, RPV600305S, RPV600314S, RPV600316S, RPV601093S, RPV601402S, RPV601261S, RPV601262S, RPV600861S, RPV601651S, RPV601695S
• Recalling Firm/ Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Technical Services; 800-929-4043
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Medtronic issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/10/2023 by UPS 2-day delivery or email. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. The notice explained the problem and the risk and requested the following patient management recommendations: - Prophylactic device replacement is NOT recommended. - Program all HV therapy pathways B>AX in all therapy zones to minimize the risk for this issue. - Prioritize reprogramming patients who have both a history of HV therapy and Rx1 programmed AX>B. - For remaining patients with AX>B programming in any HV therapy sequence, schedule (with appropriate discretion) the next follow-up for in-clinic reprogramming to minimize potential for reduced- or no-energy HV therapies to occur. - Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue: o Reduced- or no-energy HV therapy is displayed in Episode Text (regardless of programmed pathway) o A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy. Update 10/10/2023: Beginning 09/27/2023, Medtronic issued communication via letter to consignees regarding the availability of the revised IFU and SmartSync Software. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.
• Quantity in Commerce: 3005 units
• Distribution: US Nationwide - Worldwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NIK; PMAs with Product Code = NIK