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: 891 units Lot/code info: GTIN 00643169720138, Lot Serial Numbers: BLC228471H, BLC228476H, BLC228533H, BLC228541H, BLC228635H, BLC228702H, BLC228745H, BLC228827H, BLC228830H, BLC228840H, BLC228872H, BLC227820H, BLC228658H, BLC228889H, BLC228890H, BLC228895H, BLC228896H, BLC228900H, BLC228350H, BLC228567H, BLC228738H, BLC229053H, BLC229197H, BLC229064H, BLC228295H, BLC228587H, BLC228382H, BLC228585H, BLC228296H, BLC228583H, BLC228787H, BLC228926H, BLC229106H, BLC228579H, BLC228245H, BLC228551H, BLC228625H, BLC228819H, BLC228440H, BLC228622H, BLC228825H, BLC228456H, BLC228432H, BLC228960H, BLC229166H, BLC228545H, BLC228676H, BLC228695H, BLC228573H, BLC229089H, BLC228721H, BLC228898H, BLC228980H, BLC229099H, BLC228302H, BLC228256H, BLC228258H, BLC228300H, BLC228319H, BLC228355H, BLC228394H, BLC228406H, BLC228450H, BLC228461H, BLC228515H, BLC228309H, BLC228379H, BLC228491H, BLC228510H, BLC228511H, BLC228577H, BLC228707H, BLC228800H, BLC228861H, BLC229110H, BLC229192H, BLC229207H, BLC229107H, BLC228228H, BLC228312H, BLC229032H, BLC229062H, BLC229094H, BLC229161H, BLC229169H, BLC229210H, BLC228653H, BLC228685H, BLC228409H, BLC229144H, BLC228581H, BLC228940H, BLC229154H, BLC228580H, BLC228509H, BLC228593H, BLC228614H, BLC229219H, BLC228386H, BLC228466H, BLC228810H, BLC228235H, BLC228428H, BLC228462H, BLC228463H, BLC228464H, BLC228470H, BLC228485H, BLC228488H, BLC228492H, BLC228493H, BLC228495H, BLC228497H, BLC228502H, BLC228504H, BLC228508H, BLC228985H, BLC228986H, BLC228987H, BLC228999H, BLC229000H, BLC2290
00643169720138, 00763000059651
Official record: FDA (Device enforcement) ↗
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