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: 4354 units Lot/code info: GTIN 00643169217959; Lot Serial Numbers: BLJ622286S, BLJ622571S, BLJ622623S, BLJ622733S, BLJ622742S, BLJ622966S, BLJ624144S, BLJ622126S, BLJ624009S, BLJ622569S, BLJ623322S, BLJ622064S, BLJ622092S, BLJ623468S, BLJ623621S, BLJ623849S, BLJ624135S, BLJ622023S, BLJ623580S, BLJ624033S, BLJ623167S, BLJ623490S, BLJ622292S, BLJ622241S, BLJ623462S, BLJ623794S, BLJ623809S, BLJ624193S, BLJ621886S, BLJ621947S, BLJ622884S, BLJ623297S, BLJ623410S, BLJ623471S, BLJ624039S, BLJ621718S, BLJ622266S, BLJ622481S, BLJ622566S, BLJ622575S, BLJ622578S, BLJ622582S, BLJ622596S, BLJ622621S, BLJ622732S, BLJ622903S, BLJ622934S, BLJ622973S, BLJ623089S, BLJ623300S, BLJ623319S, BLJ623411S, BLJ623413S, BLJ623482S, BLJ623605S, BLJ623615S, BLJ623620S, BLJ623631S, BLJ623771S, BLJ623960S, BLJ622066S, BLJ622581S, BLJ623080S, BLJ623147S, BLJ621736S, BLJ621763S, BLJ622067S, BLJ622237S, BLJ622458S, BLJ622007S, BLJ622992S, BLJ623036S, BLJ623110S, BLJ623296S, BLJ623460S, BLJ623578S, BLJ624142S, BLJ622127S, BLJ622277S, BLJ623416S, BLJ623898S, BLJ623929S, BLJ621944S, BLJ622739S, BLJ622740S, BLJ622068S, BLJ622613S, BLJ623776S, BLJ623883S, BLJ624067S, BLJ624201S, BLJ623454S, BLJ624132S, BLJ622061S, BLJ622015S, BLJ622288S, BLJ622729S, BLJ624010S, BLJ622948S, BLJ621747S, BLJ622033S, BLJ622293S, BLJ624005S, BLJ622115S, BLJ624019S, BLJ624191S, BLJ623485S, BLJ622294S, BLJ621733S, BLJ622253S, BLJ623323S, BLJ624140S, BLJ623609S, BLJ621957S, BLJ622747S, BLJ622882S, BLJ622889S, BLJ622985S, BLJ623315S, BLJ621870S, BLJ624107S, BLJ6228
00643169217959, 00643169720343, 00643169980082
Official record: FDA (Device enforcement) ↗
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