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: 727 units Lot/code info: GTIN 00643169217928, Lot Serial Numbers: BWD609356S, BWD609450S, BWD609318S, BWD609387S, BWD609454S, BWD609558S, BWD609464S, BWD609549S, BWD609355S, BWD609467S, BWD609389S, BWD609343S, BWD609397S, BWD609567S, BWD609395S, BWD609462S, BWD609470S, BWD609316S, BWD609554S, BWD609551S, BWD609594S, BWD609391S, BWD609466S, BWD609560S, BWD609473S, BWD609288S, BWD609322S, BWD609352S, BWD609360S, BWD609465S, BWD609476S, BWD609547S, BWD609363S, BWD609472S, BWD609573S, BWD609319S, BWD609526S, BWD609570S, BWD609448S, BWD609370S, BWD609320S, BWD609367S, BWD609317S, BWD609368S, BWD609371S, BWD609385S, BWD609362S, BWD609373S, BWD609381S, BWD609346S, BWD609574S, BWD609572S, BWD609365S, BWD609357S, BWD609348S, BWD609451S, BWD609568S, BWD609386S, BWD609344S, BWD609468S, BWD609559S, BWD609569S, BWD609342S, BWD609347S, BWD609353S, BWD609566S, BWD609374S, BWD609453S, BWD609361S, BWD609459S, BWD609460S, BWD609392S, BWD609553S, BWD609562S, BWD609359S, BWD609345S, BWD609366S, BWD609384S, BWD609455S, BWD609399S, BWD609354S, BWD609461S, BWD609403S, BWD609388S, BWD609321S, BWD609458S, BWD609351S, BWD609545S; GTIN 00643169969551, Lot Serial Numbers: BWD609418S, BWD609419S, BWD609420S, BWD609421S, BWD609422S, BWD609423S, BWD609424S, BWD609425S, BWD609426S, BWD609427S, BWD609428S, BWD609429S, BWD609430S, BWD609431S, BWD609432S, BWD609433S, BWD609434S, BWD609435S, BWD609437S, BWD609438S, BWD609439S, BWD609440S, BWD609441S, BWD609442S, BWD609443S, BWD609471S, BWD609331S, BWD609315S, BWD609295S, BWD609313S, BW
00643169217928, 00643169969551, 00643169980211, 00763000612085
Official record: FDA (Device enforcement) ↗
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