Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; 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: 2884 units Lot/code info: GTIN 00763000178222, Lot Serial numbers: RTP600502S, RTP602448S, RTP600549S, RTP600551S, RTP600553S, RTP600554S, RTP600555S, RTP601566S, RTP601569S, RTP602731S, RTP602733S, RTP601785S, RTP601786S, RTP601825S, RTP601826S, RTP601620S, RTP602203S, RTP602327S, RTP600744S, RTP600745S, RTP600762S, RTP601117S, RTP601187S, RTP601231S, RTP601906S, RTP603519S, RTP600475S, RTP600228S, RTP600308S, RTP600757S, RTP601116S, RTP601219S, RTP601221S, RTP601723S, RTP601724S, RTP601907S, RTP602117S, RTP602216S, RTP601572S, RTP602154S, RTP602038S, RTP600454S, RTP600670S, RTP601041S, RTP601066S, RTP601209S, RTP601801S, RTP600394S, RTP600397S, RTP600184S, RTP601049S, RTP601072S, RTP601822S, RTP600645S, RTP603289S, RTP603604S, RTP600559S, RTP600796S, RTP601834S, RTP600396S, RTP600738S, RTP600739S, RTP600740S, RTP600741S, RTP601589S, RTP601591S, RTP601595S, RTP601596S, RTP600148S, RTP600700S, RTP600627S, RTP601567S, RTP601186S, RTP601999S, RTP600819S, RTP601857S, RTP600576S, RTP600585S, RTP600779S, RTP600829S, RTP600452S, RTP601850S, RTP602030S, RTP602285S, RTP603440S, RTP600773S, RTP600498S, RTP600970S, RTP602267S, RTP602292S, RTP601227S, RTP600896S, RTP601034S, RTP601035S, RTP602213S, RTP602271S, RTP600671S, RTP600675S, RTP601862S, RTP600509S, RTP601568S, RTP600177S, RTP600093S, RTP600190S, RTP600191S, RTP600192S, RTP600660S, RTP600662S, RTP600663S, RTP600778S, RTP600806S, RTP600917S, RTP601179S, RTP601706S, RTP601707S, RTP601788S, RTP601793S, RTP602028S, RTP602611S, RTP600303S, RTP600647S, RTP6009

UPC codes

00763000178222, 00763000178246

Source

Official record: FDA (Device enforcement) ↗

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