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: 447 units Lot/code info: GTIN 00643169218024, Lot Serial Numbers: BWJ607141S, BWJ607132S, BWJ607040S, BWJ607055S, BWJ607056S, BWJ607025S; GTIN 00643169969575, Lot Serial Numbers: BWJ607007S, BWJ607008S, BWJ607010S, BWJ607011S, BWJ607012S, BWJ607015S, BWJ607020S, BWJ607022S, BWJ607024S, BWJ607029S, BWJ607034S, BWJ607035S, BWJ607037S, BWJ607077S, BWJ607347S, BWJ607043S, BWJ607091S, BWJ607094S, BWJ607095S, BWJ607101S, BWJ607342S, BWJ607343S, BWJ607344S, BWJ606951S, BWJ606991S, BWJ606994S, BWJ607005S, BWJ607060S, BWJ607090S, BWJ607096S, BWJ607097S, BWJ607098S, BWJ607120S, BWJ607121S, BWJ607127S, BWJ607145S, BWJ607146S, BWJ607147S, BWJ607149S, BWJ607156S, BWJ607158S, BWJ607159S, BWJ607160S, BWJ607162S, BWJ607092S, BWJ607093S, BWJ607003S, BWJ607288S, BWJ607280S, BWJ607282S, BWJ607286S, BWJ607287S, BWJ606996S, BWJ606998S, BWJ607016S, BWJ607019S, BWJ607057S, BWJ607061S, BWJ607062S, BWJ607063S, BWJ607074S, BWJ607078S, BWJ607082S, BWJ607084S, BWJ607085S, BWJ607104S, BWJ607105S, BWJ607106S, BWJ607123S, BWJ607124S, BWJ607131S, BWJ607163S, BWJ607168S, BWJ607174S, BWJ607178S, BWJ607179S, BWJ607182S, BWJ607069S, BWJ607079S, BWJ607107S, BWJ607108S, BWJ607114S, BWJ607115S, BWJ607126S, BWJ607151S, BWJ607161S, BWJ607181S, BWJ607273S, BWJ607064S, BWJ607109S, BWJ607117S, BWJ607152S, BWJ607175S, BWJ607272S, BWJ607153S, BWJ607166S, BWJ607170S, BWJ607274S, BWJ607276S, BWJ607278S, BWJ607291S, BWJ607176S, BWJ606995S, BWJ606997S, BWJ607046S, BWJ607051S, BWJ607052S, BWJ607054S, BWJ607065S, BWJ607067S, BWJ607068S, BWJ607070S, BW
00643169218024, 00643169969575, 00643169980259, 00763000612122
Official record: FDA (Device enforcement) ↗
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