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: 523 units Lot/code info: GTIN 00643169720176, Lot Serial Numbers: BLP603514S, BLP603579S, BLP603583S, BLP603637S, BLP603643S, BLP603554S, BLP603588S, BLP603580S, BLP603582S, BLP603584S, BLP603585S, BLP603586S, BLP603591S, BLP603531S, BLP603552S, BLP603511S, BLP603647S, BLP603581S, BLP603545S, BLP603551S, BLP603569S, BLP603648S, BLP603808S, BLP603536S, BLP603538S, BLP603542S, BLP603543S, BLP603544S, BLP603546S, BLP603549S, BLP603550S, BLP603553S, BLP603555S, BLP603557S, BLP603558S, BLP603562S, BLP603563S, BLP603576S, BLP603577S, BLP603587S, BLP603641S, BLP603670S, BLP603671S, BLP603672S, BLP603673S, BLP603674S, BLP603675S, BLP603676S, BLP603677S, BLP603678S, BLP603729S, BLP603730S, BLP603732S, BLP603733S, BLP603734S, BLP603735S, BLP603736S, BLP603409S, BLP603529S, BLP603533S, BLP603666S, BLP603689S, BLP603716S, BLP603758S, BLP603762S, BLP603786S, BLP603794S, BLP603795S, BLP603798S, BLP603801S, BLP603804S, BLP603807S, BLP603626S, BLP603627S, BLP603628S, BLP603629S, BLP603630S, BLP603631S, BLP603632S, BLP603633S, BLP603703S, BLP603704S, BLP603705S, BLP603706S, BLP603707S, BLP603709S, BLP603710S, BLP603711S, BLP603742S, BLP603747S, BLP603748S, BLP603779S, BLP603780S, BLP603781S, BLP603782S, BLP603783S, BLP603410S, BLP603512S, BLP603513S, BLP603517S, BLP603522S, BLP603523S, BLP603524S, BLP603526S, BLP603534S, BLP603590S, BLP603613S, BLP603634S, BLP603636S, BLP603652S, BLP603653S, BLP603657S, BLP603659S, BLP603660S, BLP603661S, BLP603662S, BLP603663S, BLP603664S, BLP603665S, BLP603667S, BLP603668S, BLP6036
00643169720176, 00643169980150, 00763000612306
Official record: FDA (Device enforcement) ↗
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