Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; 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: 9325 units Lot/code info: GTIN 00763000178468. Lot Serial numbers: RSD605765S, RSD605767S, RSD607880S, RSD607881S, RSD607886S, RSD607890S, RSD603551S, RSD603552S, RSD603553S, RSD603554S, RSD603555S, RSD600536S, RSD601541S, RSD602283S, RSD602524S, RSD602542S, RSD602924S, RSD603303S, RSD603396S, RSD607136S, RSD608177S, RSD608547S, RSD606272S, RSD607000S, RSD607711S, RSD607712S, RSD602036S, RSD602645S, RSD602659S, RSD603096S, RSD603670S, RSD604815S, RSD608193S, RSD605918S, RSD605919S, RSD605920S, RSD605921S, RSD605922S, RSD605923S, RSD605924S, RSD605926S, RSD605927S, RSD605929S, RSD605930S, RSD605931S, RSD605932S, RSD605933S, RSD604238S, RSD604294S, RSD604312S, RSD604313S, RSD604314S, RSD604614S, RSD604616S, RSD604710S, RSD604721S, RSD604725S, RSD605925S, RSD607788S, RSD607789S, RSD607790S, RSD607791S, RSD607792S, RSD607793S, RSD607794S, RSD607795S, RSD607797S, RSD607800S, RSD607801S, RSD607802S, RSD609083S, RSD609084S, RSD609085S, RSD605068S, RSD608525S, RSD609065S, RSD609066S, RSD609067S, RSD609069S, RSD609071S, RSD609072S, RSD609073S, RSD609075S, RSD609079S, RSD609080S, RSD609081S, RSD609082S, RSD601603S, RSD601960S, RSD602778S, RSD603181S, RSD603321S, RSD603672S, RSD603879S, RSD606554S, RSD608293S, RSD600145S, RSD601926S, RSD602728S, RSD603152S, RSD604065S, RSD607875S, RSD603750S, RSD606677S, RSD600100S, RSD600200S, RSD601455S, RSD601551S, RSD601552S, RSD601750S, RSD602233S, RSD608150S, RSD609043S, RSD608404S, RSD608422S, RSD609843S, RSD609845S, RSD609846S, RSD603825S, RSD603826S, RSD609842S, RSD6105

UPC codes

00763000178468

Source

Official record: FDA (Device enforcement) ↗

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