Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; 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: 6536 units Lot/code info: GTIN 00643169837645, Lot Serial numbers: RPQ605053S, RPQ606292S, RPQ605067S, RPQ605093S, RPQ601699S, RPQ605875S, RPQ605881S, RPQ601451S, RPQ602698S, RPQ605503S, RPQ606300S, RPQ601185S, RPQ601351S, RPQ601948S, RPQ601950S, RPQ602093S, RPQ602202S, RPQ602212S, RPQ602402S, RPQ602403S, RPQ602595S, RPQ602960S, RPQ602961S, RPQ602985S, RPQ603049S, RPQ603082S, RPQ603318S, RPQ603408S, RPQ603450S, RPQ605289S, RPQ606079S, RPQ603112S, RPQ603355S, RPQ603428S, RPQ604101S, RPQ604644S, RPQ602479S, RPQ603775S, RPQ604354S, RPQ604567S, RPQ605754S, RPQ605514S, RPQ605535S, RPQ603729S, RPQ605540S, RPQ603758S, RPQ604571S, RPQ605118S, RPQ602683S, RPQ602692S, RPQ602715S, RPQ603495S, RPQ603504S, RPQ603555S, RPQ603644S, RPQ603647S, RPQ604572S, RPQ604621S, RPQ604622S, RPQ604684S, RPQ604686S, RPQ604777S, RPQ604953S, RPQ605095S, RPQ605164S, RPQ605353S, RPQ605428S, RPQ602526S, RPQ602527S, RPQ602702S, RPQ603503S, RPQ604660S, RPQ604880S, RPQ604892S, RPQ604942S, RPQ604951S, RPQ605209S, RPQ602359S, RPQ602686S, RPQ602740S, RPQ604375S, RPQ602680S, RPQ602720S, RPQ602365S, RPQ604944S, RPQ603730S, RPQ604712S, RPQ605182S, RPQ604730S, RPQ602700S, RPQ602713S, RPQ602721S, RPQ604311S, RPQ604941S, RPQ604532S, RPQ602043S, RPQ602834S, RPQ603511S, RPQ603931S, RPQ604691S, RPQ605315S, RPQ603657S, RPQ603726S, RPQ604957S, RPQ605526S, RPQ602494S, RPQ605547S, RPQ602706S, RPQ604873S, RPQ603732S, RPQ603733S, RPQ603531S, RPQ605548S, RPQ601399S, RPQ601363S, RPQ601475S, RPQ601503S, RPQ601784S, RPQ601787S, RPQ601820S, RPQ601876S, RPQ6020

UPC codes

00643169837645

Source

Official record: FDA (Device enforcement) ↗

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