--- title: "ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardiover... — FDA record Z-1808-2023 | Is It on Recall" description: "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)" url: https://isitonrecall.com/recall/fda-device-z-1808-2023-icd-vr-visia-mri-af-s-us-ous-df4-model-number-dvfc3d4-implantable-cardioverter-defibrillators/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators — FDA record Z-1808-2023 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; 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**: 16244 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1808-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1808-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | GTIN 00643169720817. Lot Serial Numbers: PMX613090S, PMX610759S, PMX613168S, PMX604899S, PMX606600S, PMX605030S, PMX605294S, PMX605321S, PMX605409S, PMX605434S, PMX605494S, PMX605615S, PMX605865S, PMX605971S, PMX606147S, PMX606694S, PMX606698S, PMX606701S, PMX606703S, PMX606705S, PMX606859S, PMX607270S, PMX608318S, PMX611103S, PMX613896S, PMX613927S, PMX613944S, PMX612024S, PMX613712S, PMX613935S, PMX613953S, PMX611975S, PMX613088S, PMX613697S, PMX613929S, PMX613942S, PMX607559S, PMX611696S, PMX611976S, PMX611873S, PMX607595S, PMX611948S, PMX607298S, PMX611887S, PMX612112S, PMX607539S, PMX607632S, PMX611052S, PMX612018S, PMX612108S, PMX613774S, PMX613790S, PMX607549S, PMX607599S, PMX612009S, PMX612016S, PMX612119S, PMX613709S, PMX613954S, PMX609256S, PMX607521S, PMX607529S, PMX607532S, PMX607737S, PMX607742S, PMX611286S, PMX611299S, PMX611303S, PMX611687S, PMX611688S, PMX611987S, PMX612005S, PMX612008S, PMX612019S, PMX612114S, PMX612118S, PMX613076S, PMX613077S, PMX613081S, PMX613312S, PMX613324S, PMX613437S, PMX613536S, PMX613539S, PMX613558S, PMX613561S, PMX613695S, PMX613702S, PMX613708S, PMX613711S, PMX613931S, PMX614118S, PMX614120S, PMX607517S, PMX607520S, PMX607545S, PMX607700S, PMX613443S, PMX613446S, PMX613542S, PMX613710S, PMX613714S, PMX607575S, PMX612116S, PMX613093S, PMX613328S, PMX613440S, PMX613441S, PMX607515S, PMX607524S, PMX607525S, PMX607526S, PMX607300S, PMX611159S, PMX611998S, PMX611878S, PMX611229S, PMX607516S, PMX609678S, PMX609772S, PMX611228S, PMX611275S, PMX611289S, PMX611294S, PMX611872S, PMX611879S, PMX611881S, PMX611995S, PMX611996S, PMX611997S, PMX612004S, PMX612006S, PMX612010S, PMX612013S, PMX612015S, PMX613246S, PMX613320S, PMX613448S, PMX613481S, PMX613562S, PMX613762S, PMX613938S, PMX613947S, PMX613959S, PMX605677S, PMX605029S, PMX604766S, PMX607432S, PMX607437S, PMX607733S, PMX609761S, PMX610167S, PMX610755S, PMX611397S, PMX611398S, PMX611574S, PMX613384S, PMX613568S, PMX612508S, PMX612649S, PMX613273S, PMX613486S, PMX614055S, PMX604696S, PMX604726S, PMX604749S, PMX604890S, PMX605065S, PMX605449S, PMX606036S, PMX606042S, PMX607173S, PMX607476S, PMX607555S, PMX608782S, PMX609011S, PMX609558S, PMX609947S, PMX610188S, PMX605914S, PMX606773S, PMX605433S, PMX611893S, PMX604772S, PMX604934S, PMX605439S, PMX606373S, PMX606970S, PMX606998S, PMX607080S, PMX608007S, PMX608015S, PMX608059S, PMX609130S, PMX610705S, PMX611776S, PMX613245S, PMX605863S, PMX608912S, PMX604723S, PMX604995S, PMX605377S, PMX605503S, PMX606301S, PMX607456S, PMX608303S, PMX608335S, PMX608701S, PMX609149S, PMX609213S, PMX609747S, PMX609783S, PMX609809S, PMX609839S, PMX610254S, PMX610327S, PMX610688S, PMX610853S, PMX611086S, PMX611355S, PMX611528S, PMX611609S, PMX612138S, PMX612288S, PMX605896S, PMX605973S, PMX607851S, PMX608122S, PMX610072S, PMX614021S, PMX605234S, PMX605806S, PMX605820S, PMX606636S, PMX606933S, PMX607995S, PMX608141S, PMX608328S, PMX608360S, PMX609212S, PMX609920S, PMX610548S, PMX610704S, PMX606980S, PMX609694S, PMX612497S, PMX605917S, PMX607874S, PMX612525S, PMX612839S, PMX612876S, PMX605044S, PMX606143S, PMX608634S, PMX611314S, PMX606989S, PMX606999S, PMX607276S, PMX607561S, PMX607839S, PMX607841S, PMX607845S, PMX607866S, PMX607892S, PMX608006S, PMX608104S, PMX608196S, PMX608261S, PMX608268S, PMX608302S, PMX608333S, PMX608336S, PMX608381S, PMX608387S, PMX608600S, PMX608653S, PMX608768S, PMX608917S, PMX609001S, PMX609181S, PMX609490S, PMX609515S, PMX609557S, PMX609588S, PMX609843S, PMX609978S, PMX610013S, PMX610091S, PMX610242S, PMX610262S, PMX610312S, PMX610521S, PMX610657S, PMX610817S, PMX610830S, PMX611004S, PMX611300S, PMX611322S, PMX611338S, PMX611341S, PMX611387S, PMX611413S, PMX611498S, PMX611541S, PMX611783S, PMX611979S, PMX612159S, PMX612210S, PMX612211S, PMX612215S, PMX612273S, PMX612274S, PMX612495S, PMX612496S, PMX612637S, PMX612683S, PMX612687S, PMX612690S, PMX613480S, PMX613523S, PMX613583S, PMX614294S, PMX614430S, PMX612324S, PMX606994S, PMX607033S, PMX607302S, PMX609270S, PMX609404S, PMX609551S, PMX611205S, PMX612152S, PMX612217S, PMX605970S, PMX606503S, PMX606654S, PMX607448S, PMX607965S, PMX608568S, PMX609008S, PMX609589S, PMX609721S, PMX610010S, PMX610468S, PMX610474S, PMX610782S, PMX611202S, PMX611806S, PMX613138S, PMX605666S, PMX607869S, PMX608314S, PMX605577S, PMX605807S, PMX606675S, PMX611315S, PMX609405S, PMX606954S, PMX608057S, PMX608356S, PMX608357S, PMX608633S, PMX608849S, PMX609038S, PMX610697S, PMX611629S, PMX606937S, PMX608722S, PMX609430S, PMX610055S, PMX612616S, PMX613196S, PMX613571S, PMX613696S, PMX610246S, PMX610247S, PMX609750S, PMX607204S, PMX606158S, PMX608178S, PMX604713S, PMX605855S, PMX606123S, PMX606771S, PMX607151S, PMX607548S, PMX608826S, PMX609421S, PMX609801S, PMX610926S, PMX611713S, PMX612052S, PMX612292S, PMX612769S, PMX612789S, PMX613417S, PMX613549S, PMX614304S, PMX614305S, PMX611395S, PMX612580S, PMX612617S, PMX604707S, PMX613234S, PMX612317S, PMX612932S, PMX613551S, PMX613924S, PMX604704S, PMX604786S, PMX605906S, PMX606174S, PMX606246S, PMX607760S, PMX608115S, PMX608623S, PMX608728S, PMX608821S, PMX609068S, PMX609422S, PMX609427S, PMX609878S, PMX610428S, PMX610716S, PMX610835S, PMX611401S, PMX612158S, PMX612209S, PMX612294S, PMX612712S, PMX613140S, PMX613262S, PMX613309S, PMX613415S, PMX613419S, PMX613602S, PMX614390S, PMX613871S, PMX613885S, PMX614274S, PMX614275S, PMX611644S, PMX611651S, PMX613019S, PMX608469S, PMX608965S, PMX609160S, PMX609458S, PMX611360S, PMX612768S, PMX604755S, PMX608403S, PMX610077S, PMX610833S, PMX611520S, PMX612560S, PMX614102S, PMX608970S, PMX610489S, PMX610492S, PMX611283S, PMX609131S, PMX609393S, PMX609767S, PMX609896S, PMX610371S, PMX610825S, PMX610989S, PMX611459S, PMX611550S, PMX611895S, PMX612102S, PMX612149S, PMX612160S, PMX612837S, PMX613008S, PMX613085S, PMX613145S, PMX613178S, PMX613193S, PMX613393S, PMX613516S, PMX614403S, PMX605404S, PMX605870S, PMX607472S, PMX607878S, PMX613614S, PMX609026S, PMX609178S, PMX609187S, PMX609395S, PMX609396S, PMX609398S, PMX609468S, PMX609514S, PMX609567S, PMX609766S, PMX609871S, PMX609967S, PMX610244S, PMX610367S, PMX610791S, PMX610919S, PMX610982S, PMX610987S, PMX611126S, PMX611190S, PMX611233S, PMX611579S, PMX612076S, PMX612129S, PMX612486S, PMX612515S, PMX612554S, PMX612594S, PMX612689S, PMX612940S, PMX613084S, PMX613250S, PMX614334S, PMX612796S, PMX605411S, PMX606907S, PMX607112S, PMX608263S, PMX609428S, PMX610096S, PMX610241S, PMX610861S, PMX612312S, PMX613009S, PMX614421S, PMX605498S, PMX605897S, PMX608526S, PMX609647S, PMX610374S, PMX610387S, PMX611505S, PMX613029S, PMX613142S, PMX613494S, PMX613797S, PMX604898S, PMX604699S, PMX605558S, PMX606090S, PMX607906S, PMX609608S, PMX609867S, PMX610127S, PMX610194S, PMX612191S, PMX613014S, PMX613132S, PMX613242S, PMX614007S, PMX614437S, PMX614480S, PMX613596S, PMX613597S, PMX613598S, PMX609752S, PMX610724S, PMX610740S, PMX610863S, PMX611230S, PMX611563S, PMX611910S, PMX612124S, PMX612297S, PMX612520S, PMX613012S, PMX613024S, PMX613366S, PMX613379S, PMX613499S, PMX613512S, PMX613563S, PMX613595S, PMX613621S, PMX614003S, PMX614089S, PMX614200S, PMX614459S, PMX614463S, PMX614477S, PMX608975S, PMX605339S, PMX605623S, PMX605923S, PMX606644S, PMX607768S, PMX608368S, PMX609562S, PMX612642S, PMX613553S, PMX614097S, PMX614441S, PMX610442S, PMX609049S, PMX609467S, PMX609500S, PMX609600S, PMX609939S, PMX610027S, PMX610234S, PMX610501S, PMX610665S, PMX610855S, PMX611011S, PMX611265S, PMX611371S, PMX612148S, PMX612163S, PMX612178S, PMX612228S, PMX612451S, PMX612785S, PMX612913S, PMX613015S, PMX613144S, PMX613265S, PMX613552S, PMX613630S, PMX613821S, PMX613822S, PMX614320S, PMX604892S, PMX605610S, PMX607763S, PMX607775S, PMX610019S, PMX611108S, PMX612759S, PMX613183S, PMX604712S, PMX604745S, PMX604746S, PMX605918S, PMX606144S, PMX606642S, PMX607034S, PMX607639S, PMX607888S, PMX607924S, PMX607928S, PMX608031S, PMX608613S, PMX609021S, PMX609455S, PMX610006S, PMX610057S, PMX610065S, PMX610920S, PMX611093S, PMX611235S, PMX611316S, PMX611379S, PMX611665S, PMX611759S, PMX612306S, PMX612336S, PMX612489S, PMX612899S, PMX612922S, PMX612939S, PMX613555S, PMX613576S, PMX613584S, PMX614054S, PMX614069S, PMX609063S, PMX609399S, PMX612438S, PMX613854S, PMX609641S, PMX610572S, PMX610967S, PMX612198S, PMX606459S, PMX610856S, PMX613839S, PMX610620S, PMX611148S, PMX608354S, PMX605549S, PMX607160S, PMX608161S, PMX610962S, PMX611179S, PMX611295S, PMX612822S, PMX614432S, PMX614001S, PMX609796S, PMX614412S, PMX614413S, PMX604910S, PMX605502S, PMX606776S, PMX609423S, PMX608432S, PMX608435S, PMX609279S, PMX609503S, PMX610186S, PMX610669S, PMX610897S, PMX611171S, PMX611331S, PMX611393S, PMX611473S, PMX614313S, PMX605447S, PMX606258S, PMX606677S, PMX607554S, PMX608697S, PMX608777S, PMX608883S, PMX608943S, PMX609803S, PMX609811S, PMX610789S, PMX610988S, PMX612322S, PMX613240S, PMX610066S, PMX611813S, PMX612673S, PMX613159S, PMX614283S, PMX604739S, PMX604952S, PMX605170S, PMX606296S, PMX607893S, PMX609923S, PMX609949S, PMX610172S, PMX610250S, PMX610622S, PMX610690S, PMX610726S, PMX610728S, PMX610732S, PMX611218S, PMX611353S, PMX611542S, PMX611551S, PMX611552S, PMX611875S, PMX612916S, PMX613891S, PMX614045S, PMX610632S, PMX611807S, PMX611931S, PMX612226S, PMX612266S, PMX612492S, PMX608277S, PMX608278S, PMX608280S, PMX604891S, PMX604992S, PMX604993S, PMX605152S, PMX605295S, PMX605307S, PMX605335S, PMX605496S, PMX605499S, PMX605501S, PMX605530S, PMX605531S, PMX605532S, PMX605566S, PMX605575S, PMX605601S, PMX605811S, PMX605908S, PMX605938S, PMX606374S, PMX606546S, PMX606779S, PMX606793S, PMX607362S, PMX607396S, PMX607462S, PMX607550S, PMX607573S, PMX607720S, PMX607999S, PMX608019S, PMX608050S, PMX608399S, PMX608806S, PMX608926S, PMX609392S, PMX609464S, PMX609673S, PMX612885S, PMX613566S, PMX613892S, PMX604721S, PMX604853S, PMX605135S, PMX605612S, PMX605940S, PMX606470S, PMX606729S, PMX606930S, PMX607041S, PMX607252S, PMX607273S, PMX607911S, PMX608155S, PMX608491S, PMX608802S, PMX609182S, PMX609205S, PMX609663S, PMX609956S, PMX610206S, PMX610343S, PMX610389S, PMX610533S, PMX611173S, PMX612157S, PMX612218S, PMX612670S, PMX612875S, PMX612891S, PMX612906S, PMX613624S, PMX613857S, PMX614078S, PMX614098S, PMX606064S, PMX607415S, PMX608406S, PMX608447S, PMX608919S, PMX608977S, PMX609632S, PMX610159S, PMX610163S, PMX610196S, PMX610864S, PMX613734S, PMX613887S, PMX614047S, PMX613062S, PMX613545S, PMX613547S, PMX605967S, PMX606929S, PMX607155S, PMX609043S, PMX609207S, PMX609525S, PMX609806S, PMX605638S, PMX606008S, PMX607026S, PMX607242S, PMX607455S, PMX608205S, PMX609246S, PMX609397S, PMX610487S, PMX611399S, PMX611400S, PMX609133S, PMX609537S, PMX609789S, PMX610023S, PMX610192S, PMX610664S, PMX612676S, PMX605533S, PMX608908S, PMX608920S, PMX609469S, PMX611335S, PMX604895S, PMX604944S, PMX605507S, PMX606438S, PMX606643S, PMX608377S, PMX608423S, PMX608453S, PMX608603S, PMX609019S, PMX609081S, PMX609271S, PMX609559S, PMX609575S, PMX609895S, PMX610063S, PMX610116S, PMX610160S, PMX610539S, PMX610787S, PMX610927S, PMX611214S, PMX612298S, PMX612671S, PMX613104S, PMX607203S, PMX610404S, PMX611352S, PMX612747S, PMX613332S, PMX613529S, PMX605297S, PMX605318S, PMX605981S, PMX606908S, PMX606938S, PMX606975S, PMX607129S, PMX607676S, PMX607988S, PMX607990S, PMX608479S, PMX609957S, PMX610235S, PMX610253S, PMX611273S, PMX611388S, PMX612128S, PMX612892S, PMX613007S, PMX605005S, PMX606783S, PMX607459S, PMX609409S, PMX610702S, PMX605153S, PMX608557S, PMX611845S, PMX612488S, PMX612664S, PMX613613S, PMX605336S, PMX608393S, PMX605524S, PMX605525S, PMX605526S, PMX605528S, PMX605529S, PMX607926S, PMX608649S, PMX609596S, PMX612355S, PMX607296S, PMX612767S, PMX605987S, PMX605990S, PMX607770S, PMX607772S, PMX607776S, PMX607781S, PMX607783S, PMX607786S, PMX607789S, PMX613967S, PMX613970S, PMX604976S, PMX606524S, PMX606525S, PMX606528S, PMX606537S, PMX606538S, PMX606539S, PMX606540S, PMX606542S, PMX606543S, PMX607900S, PMX608703S, PMX608704S, PMX608705S, PMX608706S, PMX608708S, PMX608709S, PMX608710S, PMX608712S, PMX608713S, PMX611809S, PMX611810S, PMX613046S, PMX6... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1808-2023%22). 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. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## 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 to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1808-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) records](https://isitonrecall.com/brand/medtronic-inc-cardiac-rhythm-and-heart-failure-crhf/)