Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators

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.

Details from the source

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. Distribution: US Nationwide - Worldwide Distribution Quantity: 16244 units Lot/code info: 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, PMX6112

UPC codes

00643169720817

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.