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: 1914 units Lot/code info: GTIN 00763000178130, Lot Serial Numbers: RTG605297S, RTG605299S, RTG600588S, RTG601635S, RTG601691S, RTG601840S, RTG601857S, RTG602986S, RTG601966S, RTG601364S, RTG601621S, RTG600270S, RTG600554S, RTG601405S, RTG601699S, RTG601977S, RTG605270S, RTG600137S, RTG600138S, RTG600181S, RTG600271S, RTG600618S, RTG600620S, RTG600621S, RTG600622S, RTG600640S, RTG601395S, RTG601441S, RTG601681S, RTG601783S, RTG601896S, RTG601945S, RTG601948S, RTG602037S, RTG602040S, RTG602042S, RTG602047S, RTG602165S, RTG602166S, RTG602167S, RTG602340S, RTG605614S, RTG602039S, RTG602228S, RTG602306S, RTG602477S, RTG605996S, RTG605997S, RTG604903S, RTG600228S, RTG600332S, RTG601906S, RTG602441S, RTG605330S, RTG605332S, RTG605838S, RTG601643S, RTG606091S, RTG600317S, RTG600255S, RTG600467S, RTG604871S, RTG605042S, RTG605051S, RTG606010S, RTG601452S, RTG602204S, RTG604466S, RTG600411S, RTG600412S, RTG600465S, RTG600517S, RTG602559S, RTG602561S, RTG602563S, RTG602565S, RTG602566S, RTG602569S, RTG602571S, RTG602573S, RTG603385S, RTG603386S, RTG603400S, RTG603404S, RTG605218S, RTG601409S, RTG601410S, RTG601525S, RTG601863S, RTG601870S, RTG603636S, RTG603637S, RTG603684S, RTG605663S, RTG601684S, RTG600188S, RTG601614S, RTG602242S, RTG600594S, RTG600612S, RTG601853S, RTG602197S, RTG600663S, RTG601900S, RTG601937S, RTG603003S, RTG600478S, RTG600514S, RTG600550S, RTG600592S, RTG601343S, RTG601396S, RTG601400S, RTG601514S, RTG601688S, RTG601697S, RTG601873S, RTG601881S, RTG602215S, RTG602524S, RTG602980S, RTG6029
00763000178130
Official record: FDA (Device enforcement) ↗
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