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.
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: 1658 units Lot/code info: GTIN 00643169837614, Lot Serial numbers: RPN602297S, RPN602079S, RPN601385S, RPN601320S, RPN601216S, RPN601977S, RPN602107S, RPN600885S, RPN601199S, RPN600682S, RPN601504S, RPN601513S, RPN601653S, RPN601681S, RPN602258S, RPN600961S, RPN600858S, RPN600867S, RPN600868S, RPN600942S, RPN601384S, RPN601398S, RPN601516S, RPN601873S, RPN601874S, RPN602264S, RPN602302S, RPN602350S, RPN602422S, RPN602462S, RPN602468S, RPN602507S, RPN601042S, RPN601529S, RPN602434S, RPN601306S, RPN601439S, RPN602416S, RPN601214S, RPN601763S, RPN601891S, RPN600750S, RPN601165S, RPN600770S, RPN601245S, RPN602186S, RPN602293S, RPN600666S, RPN600683S, RPN601094S, RPN601229S, RPN601277S, RPN601298S, RPN601393S, RPN601662S, RPN602160S, RPN600812S, RPN601674S, RPN602429S, RPN600678S, RPN602335S, RPN602420S, RPN601154S, RPN601660S, RPN602247S, RPN602355S, RPN602463S, RPN600888S, RPN601753S, RPN601619S, RPN600829S, RPN601839S, RPN601845S, RPN602501S, RPN602393S, RPN600717S, RPN600808S, RPN602021S, RPN602251S, RPN602415S, RPN600747S, RPN600985S, RPN601048S, RPN601054S, RPN601160S, RPN601168S, RPN601169S, RPN601530S, RPN601727S, RPN601864S, RPN602075S, RPN602104S, RPN602138S, RPN602161S, RPN602167S, RPN602311S, RPN602457S, RPN602489S, RPN600694S, RPN600699S, RPN601606S, RPN602442S, RPN602115S, RPN601520S, RPN600816S, RPN601106S, RPN601178S, RPN601496S, RPN601521S, RPN601611S, RPN601137S, RPN601379S, RPN601339S, RPN602014S, RPN600848S, RPN602287S, RPN602361S, RPN601211S, RPN600679S, RPN602123S, RPN602254S, RPN6010
00643169837614, 00763000206239
Official record: FDA (Device enforcement) ↗
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