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: 2748 units Lot/code info: GTIN 00763000178338, Lot Serial Numbers: RSL602442S, RSL601336S, RSL600186S, RSL602060S, RSL601499S, RSL601501S, RSL602893S, RSL602901S, RSL602941S, RSL602955S, RSL602420S, RSL602899S, RSL601490S, RSL602690S, RSL600167S, RSL600499S, RSL600561S, RSL600563S, RSL600564S, RSL600565S, RSL601867S, RSL601868S, RSL601870S, RSL601966S, RSL603729S, RSL601838S, RSL602889S, RSL600163S, RSL602444S, RSL602823S, RSL602826S, RSL603092S, RSL603105S, RSL603233S, RSL603237S, RSL603565S, RSL600206S, RSL600230S, RSL600231S, RSL601723S, RSL601789S, RSL601878S, RSL602705S, RSL602854S, RSL602828S, RSL602933S, RSL603236S, RSL601484S, RSL601988S, RSL603618S, RSL602324S, RSL602979S, RSL603759S, RSL600237S, RSL601990S, RSL600172S, RSL602465S, RSL602466S, RSL602467S, RSL602468S, RSL602469S, RSL602470S, RSL602471S, RSL602472S, RSL602892S, RSL603257S, RSL603262S, RSL603263S, RSL603264S, RSL601873S, RSL601874S, RSL601875S, RSL601876S, RSL601887S, RSL601895S, RSL602043S, RSL602044S, RSL602045S, RSL602046S, RSL602047S, RSL602048S, RSL602049S, RSL602050S, RSL602051S, RSL602052S, RSL602053S, RSL602054S, RSL602055S, RSL602056S, RSL602058S, RSL602059S, RSL602221S, RSL602222S, RSL602223S, RSL602224S, RSL602225S, RSL602227S, RSL602228S, RSL602229S, RSL602230S, RSL602231S, RSL602232S, RSL603256S, RSL603258S, RSL603259S, RSL603260S, RSL603261S, RSL601338S, RSL601339S, RSL601386S, RSL601434S, RSL601624S, RSL601626S, RSL601627S, RSL601628S, RSL601629S, RSL601630S, RSL601631S, RSL601632S, RSL601633S, RSL601634S, RSL6016
00763000178338, 00763000178352, 00763000380366
Official record: FDA (Device enforcement) ↗
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