FDAFDA · Food and drugs·Recall number Z-1808-2023
ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
Published June 28, 2023 · Recall initiated: May 10, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distributor
- US Nationwide - Worldwide Distribution
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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