Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; 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: 22,114 units Lot/code info: GTIN 00763000178345, Lot Serial Numbers: RSM612933S, RSM612934S, RSM612935S, RSM621211S, RSM604622S, RSM604623S, RSM608882S, RSM621210S, RSM621212S, RSM612673S, RSM609800S, RSM610899S, RSM619550S, RSM620275S, RSM620130S, RSM615997S, RSM619083S, RSM623383S, RSM623721S, RSM610958S, RSM616552S, RSM614351S, RSM618224S, RSM604877S, RSM612655S, RSM612656S, RSM612657S, RSM612659S, RSM621000S, RSM621003S, RSM621005S, RSM608749S, RSM608750S, RSM608751S, RSM608752S, RSM610434S, RSM610435S, RSM620999S, RSM621001S, RSM621004S, RSM617554S, RSM617555S, RSM617556S, RSM617558S, RSM617559S, RSM617557S, RSM613882S, RSM614841S, RSM615782S, RSM615936S, RSM616172S, RSM616444S, RSM619209S, RSM619289S, RSM619651S, RSM619896S, RSM620690S, RSM600889S, RSM604260S, RSM605557S, RSM606370S, RSM606396S, RSM607298S, RSM610073S, RSM610769S, RSM612584S, RSM618160S, RSM623166S, RSM600390S, RSM600757S, RSM600770S, RSM600846S, RSM600890S, RSM601127S, RSM601129S, RSM601133S, RSM604873S, RSM605085S, RSM605586S, RSM605863S, RSM605974S, RSM606168S, RSM606211S, RSM606217S, RSM606273S, RSM606468S, RSM607358S, RSM607466S, RSM608015S, RSM608017S, RSM608063S, RSM609483S, RSM609943S, RSM610757S, RSM611542S, RSM612678S, RSM614146S, RSM614433S, RSM619501S, RSM619502S, RSM610670S, RSM616050S, RSM620974S, RSM620975S, RSM620977S, RSM620978S, RSM617600S, RSM620979S, RSM611884S, RSM600128S, RSM600406S, RSM600701S, RSM600702S, RSM600783S, RSM600961S, RSM600965S, RSM600967S, RSM600973S, RSM600979S, RSM601064S, RSM601065S, RSM6035

UPC codes

00763000178345

Source

Official record: FDA (Device enforcement) ↗

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