Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; 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: 4593 units Lot/code info: GTIN 00643169720664, Lot Serial Numbers: RPD605666S, RPD602978S, RPD602979S, RPD603034S, RPD604592S, RPD601674S, RPD603271S, RPD604163S, RPD605225S, RPD604970S, RPD601851S, RPD602346S, RPD602637S, RPD603019S, RPD605081S, RPD605207S, RPD604558S, RPD604927S, RPD604980S, RPD601671S, RPD601672S, RPD601677S, RPD601678S, RPD602218S, RPD602277S, RPD602303S, RPD602369S, RPD602439S, RPD602443S, RPD602581S, RPD602724S, RPD602728S, RPD602781S, RPD602793S, RPD602910S, RPD602940S, RPD603033S, RPD603173S, RPD603180S, RPD603254S, RPD603677S, RPD603733S, RPD603756S, RPD603966S, RPD603967S, RPD604091S, RPD604124S, RPD604201S, RPD604897S, RPD605386S, RPD605444S, RPD605446S, RPD605524S, RPD605667S, RPD605679S, RPD605428S, RPD604405S, RPD604954S, RPD604941S, RPD605596S, RPD601962S, RPD602692S, RPD602918S, RPD602973S, RPD602982S, RPD605595S, RPD605601S, RPD603067S, RPD602895S, RPD604445S, RPD602694S, RPD604443S, RPD604552S, RPD605084S, RPD603878S, RPD602612S, RPD602015S, RPD602203S, RPD602244S, RPD602348S, RPD602512S, RPD602649S, RPD602813S, RPD602835S, RPD602924S, RPD603046S, RPD603061S, RPD603062S, RPD603483S, RPD603567S, RPD603785S, RPD603849S, RPD603850S, RPD603860S, RPD603870S, RPD603888S, RPD604408S, RPD604562S, RPD604598S, RPD604616S, RPD604823S, RPD604923S, RPD605011S, RPD605053S, RPD605395S, RPD605403S, RPD605624S, RPD605673S, RPD601592S, RPD603971S, RPD604019S, RPD604497S, RPD604806S, RPD604924S, RPD605172S, RPD605252S, RPD605645S, RPD603584S, RPD605643S, RPD602423S, RPD604221S, RPD6019

UPC codes

00643169720664

Source

Official record: FDA (Device enforcement) ↗

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