CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators

Summary

The FDA issued a Class I for CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardio 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

CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators

Lot/Code Info: GTIN 00643169720244, Lot Serial Numbers: BLY602416S, BLY602685S, BLY602482S, BLY602743S, BLY602431S, BLY602548S, BLY602563S, BLY602693S, BLY602474S, BLY602424S, BLY602465S, BLY602812S, BLY602676S, BLY602445S, BLY602572S, BLY602497S, BLY602549S, BLY602715S, BLY602735S, BLY602531S, BLY602657S, BLY603005S, BLY602489S, BLY602628S, BLY602652S, BLY602459S, BLY602483S, BLY602576S, BLY602450S, BLY602521S, BLY602574S, BLY602680S, BLY602386S, BLY602463S, BLY602694S, BLY602747S, BLY602449S, BLY602401S, BLY602413S, BLY602432S, BLY602631S, BLY602633S, BLY602672S, BLY602740S, BLY602741S, BLY602403S, BLY602412S, BLY602517S, BLY602528S, BLY602430S, BLY602501S, BLY602270S, BLY602552S, BLY602713S, BLY602478S, BLY602543S, BLY602443S, BLY602464S, BLY602634S, BLY602421S, BLY602564S, BLY602462S, BLY602525S, BLY602673S, BLY602717S, BLY602734S, BLY602467S, BLY602487S, BLY602377S, BLY602682S, BLY602712S, BLY602423S, BLY602659S, BLY602725S, BLY602393S, BLY602524S, BLY602565S, BLY602630S, 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BLY603384S, BLY603564S, BLY603568S, BLY603592S, BLY603593S, BLY603729S, BLY603741S, BLY603759S, BLY603778S, BLY603779S, BLY603780S, BLY603783S, BLY603795S, BLY603846S, BLY603851S, BLY603880S, BLY603881S, BLY603885S, BLY603886S, BLY603887S, BLY603928S, BLY603929S, BLY603995S, BLY604009S, BLY604019S, BLY604083S, BLY604095S, BLY604100S, BLY604101S, BLY604117S, BLY604126S, BLY604136S, BLY604137S, BLY604160S, BLY604173S, BLY604180S, BLY604182S, BLY604200S, BLY604202S, BLY604211S, BLY604239S, BLY604285S, BLY604288S, BLY604289S, BLY604290S, BLY604306S, BLY604313S, BLY604314S, BLY604317S, BLY604318S, BLY604319S, BLY604323S, BLY604327S, BLY604337S, BLY604346S, BLY604352S, BLY604354S, BLY604355S, BLY604369S, BLY604370S, BLY604402S, BLY604441S, BLY604442S, BLY604443S, BLY604444S, BLY604445S, BLY603492S, BLY602777S, BLY602779S, BLY602979S, BLY603073S, BLY603266S, BLY603356S, BLY603406S, BLY603426S, BLY603675S, BLY602888S, BLY603558S, BLY603691S, BLY603801S, BLY603936S, BLY603953S, BLY603967S, BLY604205S, BLY604207S, BLY604217S, BLY604218S, BLY604225S, BLY603679S, BLY603904S, BLY603186S, BLY603506S, BLY602906S, BLY602950S, BLY603230S, BLY603370S, BLY602964S, BLY603187S, BLY602861S, BLY602925S, BLY602937S, BLY603401S, BLY603435S, BLY603376S, BLY603074S, BLY603680S, BLY603787S, BLY603969S, BLY603620S, BLY603652S, BLY603217S, BLY602896S, BLY603010S, BLY603222S, BLY603098S, BLY604256S, BLY604257S, BLY602768S, BLY604017S, BLY603651S, BLY603809S, BLY603091S, BLY604034S, BLY602955S, BLY603044S, BLY603235S, BLY603402S, BLY603441S, BLY603488S, BLY603493S, BLY603718S, BLY603839S, BLY603895S, BLY604016S, BLY604118S, BLY604167S, BLY603573S, BLY604032S, BLY603381S, BLY603431S, BLY603763S, BLY603933S, BLY604042S, BLY604124S, BLY604179S, BLY603312S, BLY603315S, BLY602938S, BLY603018S, BLY603361S, BLY603730S, BLY602794S, BLY603104S, BLY603348S, BLY603490S, BLY604206S, BLY604222S, BLY604265S, BLY604271S, BLY602795S, BLY603449S, BLY603638S, BLY603828S, BLY603884S, BLY604055S, BLY604078S, BLY604201S, BLY603761S, BLY603329S, BLY603407S, BLY603714S, BLY603800S, BLY603820S, BLY603826S, BLY603847S, BLY604027S, BLY604272S, BLY604332S, BLY603281S, BLY602762S, BLY602797S, BLY602793S, BLY603495S, BLY602882S, BLY602947S, BLY603237S, BLY603463S, BLY603479S, BLY603602S, BLY603866S, BLY603999S, BLY604051S, BLY603286S, BLY603157S, BLY603219S, BLY603369S, BLY603386S, BLY602798S, BLY603701S, BLY604123S, BLY602843S, BLY603498S, BLY603503S, BLY603776S, BLY603387S, BLY603446S, BLY604068S, BLY603247S, BLY603255S, BLY603272S, BLY603396S, BLY603430S, BLY603725S, BLY603873S, BLY604053S, BLY604087S, BLY604282S, BLY603017S, BLY603079S, BLY603246S, BLY603843S, BLY603876S, BLY603022S, BLY603424S, BLY603852S, BLY602908S, BLY602923S, BLY602936S, BLY602956S, BLY603453S, BLY603703S, BLY603352S, BLY603440S, BLY603508S, BLY603519S, BLY603520S, BLY603530S, BLY603548S, BLY603577S, BLY603586S, BLY603588S, BLY603590S, BLY603629S, BLY603639S, BLY603640S, BLY603649S, BLY603697S, BLY603911S, BLY603320S, BLY603411S, BLY603425S, BLY603512S, BLY603556S, BLY603595S, BLY603690S, BLY603700S, BLY603702S, BLY603709S, BLY603710S, BLY603713S, BLY604043S, BLY604113S, BLY604204S, BLY603324S, BLY603328S, BLY603337S, BLY603341S, BLY603344S, BLY603354S, BLY603357S, BLY603399S, BLY603451S, BLY603468S, BLY603476S, BLY603480S, BLY603505S, BLY603516S, BLY603522S, BLY603523S, BLY603526S, BLY603532S, BLY603540S, BLY603549S, BLY603569S, BLY603571S, BLY603583S, BLY603587S, BLY603596S, BLY603637S, BLY603656S, BLY603671S, BLY603672S, BLY603678S, BLY603682S, BLY603692S, BLY603705S, BLY603707S, BLY603755S, BLY603792S, BLY603799S, BLY603823S, BLY603924S, BLY603932S, BLY603934S, BLY603938S, BLY603950S, BLY603968S, BLY603975S, BLY604075S, BLY604080S, BLY604114S, BLY604181S, BLY604220S, BLY602924S, BLY603155S, BLY603108S, BLY603301S, BLY602963S, BLY603296S, BLY604067S, BLY604307S, BLY604431S, BLY603215S, BLY603289S, BLY603918S, BLY603258S, BLY603343S, BLY604374S, BLY602968S, BLY604064S, BLY604375S, BLY604433S, BLY602864S, BLY602914S, BLY603326S, BLY604302S, BLY604360S, BLY602865S, BLY603297S, BLY603334S, BLY603696S, BLY603721S, BLY602969S, BLY603345S, BLY604120S, BLY602863S, BLY603322S, BLY604084S, BLY602915S, BLY603870S, BLY604309S, BLY602869S, BLY602870S, BLY604437S, BLY604425S, BLY603254S, BLY603118S, BLY603945S, BLY603990S, BLY604157S, BLY604228S, BLY604432S, BLY603293S, BLY603295S, BLY603298S, BLY603318S, BLY603319S, BLY603325S, BLY603335S, BLY603667S, BLY603910S, BLY603944S, BLY604065S, BLY604066S, BLY604174S, BLY604247S, BLY604248S, BLY604320S, BLY604322S, BLY604424S, BLY603028S, BLY603323S, BLY604245S, BLY604325S, BLY602759S, BLY603447S, BLY603737S, BLY603770S, BLY604338S, BLY604252S, BLY604367S, BLY604372S, BLY604387S, BLY604394S, BLY604420S, BLY603993S, BLY604007S, BLY604057S, BLY604059S, BLY604253S, BLY603704S, BLY604254S, BLY603454S, BLY604273S, BLY603879S, BLY604035S, BLY603753S, BLY603012S, BLY603029S, BLY603699S, BLY604368S, BLY604227S, BLY603494S, BLY603107S, BLY603261S, BLY603830S, BLY604224S, BLY604286S, BLY604297S, BLY602766S, BLY602800S, BLY602804S, BLY604345S, BLY604404S, BLY603788S, BLY604104S, BLY603648S, BLY603093S, BLY602808S, BLY602856S, BLY603100S, BLY603374S, BLY603389S, BLY603452S, BLY603527S, BLY603582S, BLY603845S, BLY603805S, BLY604134S, BLY604262S, BLY604343S, BLY604377S, BLY602900S, BLY603578S, BLY604056S, BLY603132S, BLY603133S, BLY603176S, BLY603177S, BLY603265S, BLY603360S, BLY603412S, BLY603513S, BLY603544S, BLY603557S, BLY603575S, BLY603601S, BLY603613S, BLY603727S, BLY603736S, BLY603751S, BLY603762S, BLY603865S, BLY603883S, BLY604012S, BLY604039S, BLY604061S, BLY604089S, BLY604147S, BLY604172S, BLY604190S, BLY604236S, BLY604280S, BLY604293S, BLY604301S, BLY604308S, BLY604316S, BLY604328S, BLY604336S, BLY604356S, BLY604357S, BLY604364S, BLY604365S, BLY604391S, BLY604406S, BLY604393S, BLY604422S, BLY604249S, BLY604371S, BLY604430S, BLY604125S, BLY603349S, BLY603353S, BLY603427S, BLY603439S, BLY603472S, BLY603474S, BLY603515S, BLY603518S, BLY603537S, BLY603539S, BLY603541S, BLY603547S, BLY603565S, BLY603597S, BLY603623S, BLY603636S, BLY603645S, BLY603681S, BLY603683S, BLY603698S, BLY603711S, BLY603723S, BLY603735S, BLY603738S, BLY603772S, BLY603773S, BLY603790S, BLY603794S, BLY603802S, BLY603915S, BLY603921S, BLY603930S, BLY603937S, BLY603946S, BLY603947S, BLY603948S, BLY603958S, BLY603985S, BLY604074S, BLY604076S, BLY604091S, BLY604102S, BLY604109S, BLY604121S, BLY604128S, BLY604135S, BLY604144S, BLY604166S, BLY604219S, BLY604229S, BLY604230S, BLY604251S, BLY603563S, BLY603987S, BLY604296S, BLY604353S, BLY604418S, BLY603614S, BLY603836S, BLY603959S, BLY604092S, BLY604250S, BLY604390S, BLY604395S, BLY603486S, BLY603580S, BLY603916S, BLY603976S, BLY604185S, BLY604002S, BLY603011S, BLY604138S, BLY604194S, BLY604413S, BLY604324S, BLY603338S, BLY603864S, BLY604127S, BLY603954S, BLY604429S, BLY603974S, BLY604112S, BLY604107S, BLY604223S, BLY603949S, BLY604386S, BLY604260S, BLY604416S, BLY604426S, BLY604427S, BLY604398S, BLY604403S, BLY604405S, BLY604409S, BLY604410S, BLY604423S, BLY604436S, BLY604448S, BLY604450S, BLY604414S; GTIN 00763000612337, Lot Serial Numbers: BLY604454S, BLY604464S, BLY604463S, BLY604461S, BLY604462S, BLY604465S, BLY604466S, BLY604467S, BLY604468S

Quantity Affected: 1754 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