Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; 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: 11375 units Lot/code info: GTIN 00643169720701, Lot Serial Numbers: RPH603922S, RPH608147S, RPH603531S, RPH607413S, RPH607373S, RPH604394S, RPH606758S, RPH603572S, RPH606941S, RPH603152S, RPH603203S, RPH603999S, RPH604021S, RPH606976S, RPH603841S, RPH604928S, RPH605779S, RPH605780S, RPH606559S, RPH606577S, RPH606694S, RPH606731S, RPH606795S, RPH607014S, RPH607015S, RPH607016S, RPH607157S, RPH607244S, RPH607443S, RPH607748S, RPH608114S, RPH607674S, RPH607675S, RPH607677S, RPH607681S, RPH607688S, RPH609399S, RPH607884S, RPH608003S, RPH608138S, RPH608464S, RPH608655S, RPH608676S, RPH608835S, RPH608853S, RPH608950S, RPH608952S, RPH608958S, RPH609021S, RPH609279S, RPH609280S, RPH609281S, RPH609282S, RPH607432S, RPH609308S, RPH607753S, RPH603849S, RPH603912S, RPH603913S, RPH604139S, RPH604140S, RPH604142S, RPH604266S, RPH604267S, RPH604268S, RPH604435S, RPH604692S, RPH604708S, RPH604785S, RPH605048S, RPH605058S, RPH605167S, RPH605790S, RPH605824S, RPH605882S, RPH606393S, RPH606447S, RPH606491S, RPH606568S, RPH607305S, RPH607306S, RPH607412S, RPH607414S, RPH607568S, RPH607801S, RPH607969S, RPH607970S, RPH608423S, RPH608424S, RPH608644S, RPH609447S, RPH609514S, RPH604243S, RPH602654S, RPH603493S, RPH603502S, RPH607247S, RPH607311S, RPH609270S, RPH603130S, RPH603730S, RPH603928S, RPH604193S, RPH604283S, RPH603527S, RPH602526S, RPH603472S, RPH603477S, RPH603490S, RPH604194S, RPH604360S, RPH607312S, RPH607757S, RPH602973S, RPH603497S, RPH604189S, RPH604285S, RPH604877S, RPH603478S, RPH603727S, RPH604282S, RPH6034

UPC codes

00643169720701

Source

Official record: FDA (Device enforcement) ↗

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