Recall archive / FDA device enforcement

ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators — FDA record Z-1805-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
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.
Classification: Class I
Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity: 4546 units
Agency-reported status: Ongoing
Source record identifier: Z-1805-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
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CWH605180S, CWH605259S, CWH605380S, CWH605393S, CWH603758S, CWH603949S, CWH604620S, CWH605555S, CWH601365S, CWH601930S, CWH602417S, CWH602462S, CWH602559S, CWH602736S, CWH602923S, CWH603142S, CWH603473S, CWH603504S, CWH603570S, CWH603690S, CWH603852S, CWH604002S, CWH604193S, CWH604216S, CWH601631S, CWH601656S, CWH602315S, CWH602412S, CWH602492S, CWH602921S, CWH603019S, CWH603138S, CWH604590S, CWH605242S, CWH602872S, CWH603672S, CWH603823S, CWH600991S, CWH601434S, CWH601823S, CWH602767S, CWH603975S, CWH602115S, CWH603984S, CWH601104S, CWH601733S, CWH603031S, CWH603559S, CWH603585S, CWH603773S, CWH603875S, CWH603990S, CWH603997S, CWH604716S, CWH604796S, CWH604952S, CWH605414S, CWH605423S, CWH601995S, CWH602494S, CWH602622S, CWH604339S, CWH604854S, CWH602522S, CWH604037S, CWH605390S, CWH601515S, CWH602385S, CWH604574S, CWH600987S, CWH601153S, CWH602133S, CWH602160S, CWH602943S, CWH603360S, CWH603429S, CWH603814S, CWH604754S, CWH604778S, CWH604951S, CWH604983S, CWH604286S, CWH601676S, 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CWH602282S, CWH602324S, CWH602342S, CWH602386S, CWH602449S, CWH602466S, CWH6...

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Details supplied by the agency

Lot, code or applicability

GTIN 00643169837805, Lot Serial Numbers: CWH604762S, CWH602704S, CWH604287S, CWH601113S, CWH602355S, CWH601417S, CWH601422S, CWH601423S, CWH603581S, CWH602459S, CWH602700S, CWH601632S, CWH601887S, CWH602686S, CWH602952S, CWH603048S, CWH604506S, CWH604849S, CWH605365S, CWH605366S, CWH605549S, CWH602311S, CWH603176S, CWH603389S, CWH601114S, CWH601326S, CWH601494S, CWH601599S, CWH601907S, CWH601934S, CWH602005S, CWH602031S, CWH602068S, CWH602379S, CWH602640S, CWH602643S, CWH602875S, CWH602966S, CWH603029S, CWH603161S, CWH603186S, CWH604179S, CWH604365S, CWH604848S, CWH605143S, CWH605152S, CWH605229S, CWH605231S, CWH601040S, CWH601241S, CWH602091S, CWH602139S, CWH602556S, CWH602717S, CWH603107S, CWH603227S, CWH603322S, CWH603327S, CWH603472S, CWH603986S, CWH604007S, CWH604304S, CWH604619S, CWH604856S, CWH604885S, CWH604939S, CWH604949S, CWH605132S, CWH605170S, CWH605306S, CWH605355S, CWH605386S, CWH605421S, CWH605553S, CWH601042S, CWH601324S, CWH601385S, CWH601970S, CWH602573S, CWH603036S, CWH603079S, CWH603431S, CWH603434S, CWH603477S, CWH603821S, CWH603840S, CWH603953S, CWH604240S, CWH604483S, CWH604632S, CWH604921S, CWH604975S, CWH605095S, CWH605179S, CWH605357S, CWH605359S, CWH605422S, CWH601010S, CWH601803S, CWH601935S, CWH601972S, CWH602411S, CWH602435S, CWH602708S, CWH602709S, CWH603306S, CWH603642S, CWH604021S, CWH604115S, CWH604160S, CWH604301S, CWH604344S, CWH604451S, CWH604587S, CWH604732S, CWH604811S, CWH604842S, CWH604918S, CWH604946S, CWH605157S, CWH605546S, CWH605547S, CWH604272S, CWH604844S, CWH604866S, CWH605116S, CWH600969S, CWH601002S, CWH601157S, CWH601160S, CWH601166S, CWH601244S, CWH601278S, CWH601297S, CWH601337S, CWH601343S, CWH601371S, CWH601485S, CWH601499S, CWH601787S, CWH601797S, CWH601804S, CWH601829S, CWH601902S, CWH601931S, CWH601968S, CWH602000S, CWH602030S, CWH602034S, CWH602165S, CWH602254S, CWH602270S, CWH602294S, CWH602309S, CWH602329S, CWH602409S, CWH602658S, CWH602743S, CWH602772S, CWH602947S, CWH602949S, CWH603039S, CWH603041S, CWH603062S, CWH603373S, CWH603427S, CWH603487S, CWH603621S, CWH603674S, CWH603720S, CWH603909S, CWH604017S, CWH604196S, CWH604202S, CWH604243S, CWH604323S, CWH604424S, CWH604530S, CWH604647S, CWH604702S, CWH604869S, CWH604880S, CWH604886S, CWH605005S, CWH605012S, CWH605038S, CWH605097S, CWH605119S, CWH605125S, CWH605139S, CWH605220S, CWH605299S, CWH605371S, CWH605392S, CWH605482S, CWH601095S, CWH601327S, CWH601430S, CWH601699S, CWH602245S, CWH602904S, CWH603049S, CWH604749S, CWH604929S, CWH604980S, CWH605502S, CWH603343S, CWH604061S, CWH604857S, CWH605077S, CWH604970S, CWH605362S, CWH602616S, CWH603463S, CWH603499S, CWH603582S, CWH604794S, CWH601692S, CWH601898S, CWH602868S, CWH604853S, CWH605047S, CWH605449S, CWH605472S, CWH601032S, CWH601491S, CWH602701S, CWH602856S, CWH603854S, CWH604774S, CWH605046S, CWH605435S, CWH601850S, CWH602275S, CWH602582S, CWH604015S, CWH604790S, CWH604799S, CWH604695S, CWH605346S, CWH601387S, CWH601695S, CWH601745S, CWH602056S, CWH602288S, CWH602759S, CWH603305S, CWH603492S, CWH603835S, CWH603983S, CWH604341S, CWH604415S, CWH604524S, CWH604583S, CWH604585S, CWH604871S, CWH604883S, CWH604894S, CWH604914S, CWH604955S, CWH605014S, CWH605315S, CWH605408S, CWH605434S, CWH605540S, CWH601784S, CWH601820S, CWH602021S, CWH602639S, CWH602796S, CWH602870S, CWH603485S, CWH604779S, CWH604829S, CWH605303S, CWH605051S, CWH605363S, CWH605541S, CWH604516S, CWH604611S, CWH605013S, CWH601353S, CWH601360S, CWH602163S, CWH602631S, CWH602710S, CWH603042S, CWH603156S, CWH603676S, CWH603829S, CWH604269S, CWH604410S, CWH604613S, CWH604664S, CWH605503S, CWH601502S, CWH602137S, CWH602284S, CWH602591S, CWH603054S, CWH604294S, CWH604904S, CWH605133S, CWH605551S, CWH603307S, CWH603308S, CWH603409S, CWH603657S, CWH603678S, CWH603785S, CWH603803S, CWH604001S, CWH604005S, CWH604013S, CWH604118S, CWH604226S, CWH604268S, CWH604333S, CWH604436S, CWH604438S, CWH604440S, CWH604518S, CWH604548S, CWH604577S, CWH604628S, CWH604629S, CWH604676S, CWH604782S, CWH604784S, CWH604840S, CWH604889S, CWH604895S, CWH604897S, CWH604899S, CWH604925S, CWH604927S, CWH605071S, CWH605093S, CWH605111S, CWH605129S, CWH605138S, CWH605163S, CWH605224S, CWH605233S, CWH605252S, CWH605254S, CWH605276S, CWH605319S, CWH605350S, CWH605429S, CWH605468S, CWH601127S, CWH601130S, CWH601149S, CWH601161S, CWH601165S, CWH601253S, CWH601301S, CWH601325S, CWH601338S, CWH601503S, CWH601543S, CWH601683S, CWH601685S, CWH601715S, CWH601775S, CWH601783S, CWH601788S, CWH601984S, CWH602076S, CWH602116S, CWH602138S, CWH602184S, CWH602677S, CWH602765S, CWH602776S, CWH602869S, CWH602965S, CWH603007S, CWH603081S, CWH603145S, CWH603190S, CWH603332S, CWH603649S, CWH604029S, CWH604076S, CWH604086S, CWH604142S, CWH604161S, CWH604213S, CWH604238S, CWH604248S, CWH604250S, CWH604255S, CWH604258S, CWH604296S, CWH604305S, CWH604313S, CWH604354S, CWH604397S, CWH604403S, CWH604522S, CWH604527S, CWH604565S, CWH604566S, CWH604744S, CWH604756S, CWH604767S, CWH604884S, CWH605068S, CWH605171S, CWH605172S, CWH605173S, CWH605260S, CWH605261S, CWH605270S, CWH605295S, CWH605364S, CWH605410S, CWH605466S, CWH605469S, CWH605499S, CWH602711S, CWH602931S, CWH603135S, CWH604251S, CWH604584S, CWH604618S, CWH604700S, CWH604922S, CWH605041S, CWH605135S, CWH605141S, CWH605258S, CWH605360S, CWH603775S, CWH604336S, CWH604830S, CWH600990S, CWH601781S, CWH602618S, CWH602725S, CWH602726S, CWH603092S, CWH603120S, CWH603134S, CWH603321S, CWH604149S, CWH604504S, CWH604752S, CWH604855S, CWH604878S, CWH605134S, CWH605307S, CWH601561S, CWH601658S, CWH603375S, CWH603636S, CWH605181S, CWH604839S, CWH605245S, CWH605483S, CWH603193S, CWH604832S, CWH602106S, CWH602149S, CWH602577S, CWH602588S, CWH603330S, CWH603464S, CWH604824S, CWH605036S, CWH605207S, CWH605548S, CWH601146S, CWH601525S, CWH601682S, CWH602488S, CWH602584S, CWH603043S, CWH603549S, CWH603692S, CWH604022S, CWH604275S, CWH604742S, CWH601596S, CWH601081S, CWH601084S, CWH601088S, CWH601117S, CWH601158S, CWH601335S, CWH601339S, CWH601432S, CWH601651S, CWH601740S, CWH601838S, CWH602183S, CWH602322S, CWH602751S, CWH602901S, CWH604692S, CWH604968S, CWH601848S, CWH605026S, CWH605175S, CWH601082S, CWH601454S, CWH601609S, CWH601821S, CWH601830S, CWH602130S, CWH602681S, CWH602742S, CWH603250S, CWH604416S, CWH601805S, CWH603130S, CWH602119S, CWH603403S, CWH603686S, CWH604156S, CWH600972S, CWH601076S, CWH601109S, CWH601453S, CWH602402S, CWH602540S, CWH604220S, CWH604552S, CWH604843S, CWH604910S, CWH605055S, CWH605230S, CWH605290S, CWH605342S, CWH605345S, CWH605381S, CWH600935S, CWH601410S, CWH602365S, CWH603315S, CWH604788S, CWH604926S, CWH605237S, CWH605343S, CWH605412S, CWH601778S, CWH601779S, CWH605086S, CWH601754S, CWH602131S, CWH602644S, CWH604395S, CWH602173S, CWH603865S, CWH604787S, CWH601070S, CWH601541S, CWH601826S, CWH602280S, CWH602690S, CWH601024S, CWH601175S, CWH601527S, CWH601773S, CWH601827S, CWH601837S, CWH602266S, CWH602345S, CWH602682S, CWH602990S, CWH603338S, CWH603755S, CWH601317S, CWH601162S, CWH601753S, CWH602768S, CWH603059S, CWH603781S, CWH604525S, CWH604759S, CWH605191S, CWH601077S, CWH601476S, CWH601905S, CWH602023S, CWH602603S, CWH603825S, CWH603910S, CWH604135S, CWH604312S, CWH604816S, CWH601063S, CWH601064S, CWH601065S, CWH601668S, CWH602607S, CWH602756S, CWH604520S, CWH605150S, CWH604058S, CWH600971S, CWH601759S, CWH601943S, CWH602477S, CWH603908S, CWH603944S, CWH604473S, CWH603411S, CWH604303S, CWH604461S, CWH604496S, CWH601292S, CWH601319S, CWH601504S, CWH601667S, CWH602260S, CWH602495S, CWH602684S, CWH602920S, CWH603421S, CWH603423S, CWH603502S, CWH603546S, CWH603616S, CWH604242S, CWH604288S, CWH604571S, CWH604747S, CWH605256S, CWH601016S, CWH602641S, CWH601260S, CWH603778S, CWH603055S, CWH603057S, CWH601992S, CWH602971S, CWH603815S, CWH603388S, CWH604465S, CWH604595S, CWH601033S, CWH601276S, CWH601492S, CWH601588S, CWH601799S, CWH601938S, CWH601971S, CWH602024S, CWH602468S, CWH602554S, CWH602661S, CWH602678S, CWH602739S, CWH603088S, CWH603337S, CWH603560S, CWH603597S, CWH603987S, CWH604509S, CWH601072S, CWH602707S, CWH603026S, CWH603158S, CWH604204S, CWH604575S, CWH602647S, CWH600952S, CWH601073S, CWH601156S, CWH601228S, CWH601653S, CWH601777S, CWH601831S, CWH602088S, CWH602261S, CWH602262S, CWH602263S, CWH602381S, CWH602397S, CWH602565S, CWH602601S, CWH602657S, CWH602675S, CWH602737S, CWH602825S, CWH603384S, CWH603796S, CWH603920S, CWH604273S, CWH604535S, CWH605436S, CWH600970S, CWH600988S, CWH601145S, CWH601274S, CWH601555S, CWH602667S, CWH603025S, CWH603319S, CWH603399S, CWH603412S, CWH603654S, CWH603661S, CWH604722S, CWH600820S, CWH600992S, CWH601205S, CWH601277S, CWH601633S, CWH601928S, CWH601953S, CWH601957S, CWH602105S, CWH602571S, CWH602645S, CWH602922S, CWH603020S, CWH603022S, CWH603035S, CWH603149S, CWH603187S, CWH603312S, CWH603318S, CWH603378S, CWH603509S, CWH603605S, CWH603787S, CWH603853S, CWH604100S, CWH604277S, CWH604531S, CWH604534S, CWH604540S, CWH604763S, CWH604802S, CWH604852S, CWH604971S, CWH605001S, CWH605180S, CWH605259S, CWH605380S, CWH605393S, CWH603758S, CWH603949S, CWH604620S, CWH605555S, CWH601365S, CWH601930S, CWH602417S, CWH602462S, CWH602559S, CWH602736S, CWH602923S, CWH603142S, CWH603473S, CWH603504S, CWH603570S, CWH603690S, CWH603852S, CWH604002S, CWH604193S, CWH604216S, CWH601631S, CWH601656S, CWH602315S, CWH602412S, CWH602492S, CWH602921S, CWH603019S, CWH603138S, CWH604590S, CWH605242S, CWH602872S, CWH603672S, CWH603823S, CWH600991S, CWH601434S, CWH601823S, CWH602767S, CWH603975S, CWH602115S, CWH603984S, CWH601104S, CWH601733S, CWH603031S, CWH603559S, CWH603585S, CWH603773S, CWH603875S, CWH603990S, CWH603997S, CWH604716S, CWH604796S, CWH604952S, CWH605414S, CWH605423S, CWH601995S, CWH602494S, CWH602622S, CWH604339S, CWH604854S, CWH602522S, CWH604037S, CWH605390S, CWH601515S, CWH602385S, CWH604574S, CWH600987S, CWH601153S, CWH602133S, CWH602160S, CWH602943S, CWH603360S, CWH603429S, CWH603814S, CWH604754S, CWH604778S, CWH604951S, CWH604983S, CWH604286S, CWH601676S, CWH601071S, CWH601243S, CWH601037S, CWH602071S, CWH603023S, CWH605267S, CWH601416S, CWH601420S, CWH604183S, CWH604342S, CWH605208S, CWH605257S, CWH602575S, CWH602576S, CWH602627S, CWH602636S, CWH603177S, CWH603675S, CWH603948S, CWH604194S, CWH604207S, CWH604544S, CWH604555S, CWH604777S, CWH604995S, CWH605039S, CWH605056S, CWH605117S, CWH600967S, CWH603028S, CWH603189S, CWH604079S, CWH604198S, CWH602744S, CWH602995S, CWH601401S, CWH601607S, CWH602740S, CWH603550S, CWH601652S, CWH602203S, CWH603011S, CWH603459S, CWH604044S, CWH601101S, CWH605108S, CWH605474S, CWH601029S, CWH603000S, CWH603278S, CWH603714S, CWH601398S, CWH602350S, CWH602392S, CWH602548S, CWH602550S, CWH602552S, CWH602699S, CWH602866S, CWH602867S, CWH601612S, CWH603548S, CWH604806S, CWH601173S, CWH604993S, CWH601221S, CWH601780S, CWH602489S, CWH603482S, CWH603952S, CWH605244S, CWH601854S, CWH601394S, CWH601395S, CWH602703S, CWH600986S, CWH604031S, CWH604501S, CWH605140S, CWH602108S, CWH602162S, CWH603404S, CWH604597S, CWH601031S, CWH601322S, CWH601954S, CWH603851S, CWH604598S, CWH605330S, CWH605470S, CWH603153S, CWH603154S, CWH603439S, CWH605265S, CWH601134S, CWH602598S, CWH603849S, CWH604924S, CWH603911S, CWH604705S, CWH601790S, CWH602689S, CWH605335S, CWH601770S, CWH602020S, CWH602652S, CWH603197S, CWH603877S, CWH604047S, CWH605069S, CWH601075S, CWH601112S, CWH601099S, CWH604200S, CWH604201S, CWH604309S, CWH603673S, CWH603999S, CWH602746S, CWH603471S, CWH603974S, CWH605280S, CWH603668S, CWH605336S, CWH600994S, CWH601068S, CWH601352S, CWH601634S, CWH601717S, CWH601796S, CWH601824S, CWH601939S, CWH602073S, CWH602290S, CWH602394S, CWH602398S, CWH602612S, CWH602634S, CWH603008S, CWH603047S, CWH603152S, CWH603309S, CWH603460S, CWH603722S, CWH604043S, CWH604081S, CWH602354S, CWH604308S, CWH605247S, CWH601021S, CWH601249S, CWH601310S, CWH601057S, CWH604097S, CWH601059S, CWH604405S, CWH604666S, CWH604409S, CWH601120S, CWH601169S, CWH601483S, CWH601514S, CWH601696S, CWH601714S, CWH602015S, CWH602016S, CWH602282S, CWH602324S, CWH602342S, CWH602386S, CWH602449S, CWH602466S, CWH6...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide - Worldwide Distribution

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jun 28, 2023
Recall initiation date: May 10, 2023
Center classification date: Jun 16, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records