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: 5215 units Lot/code info: GTIN 00763000001520, Lot Serial Numbers: CWK604305S, CWK601554S, CWK601693S, CWK601762S, CWK603310S, CWK600674S, CWK605298S, CWK605119S, CWK605216S, CWK605052S, CWK605244S, CWK605024S, CWK605176S, CWK605108S, CWK605326S, CWK605015S, CWK605215S, CWK605100S, CWK605123S, CWK604958S, CWK605229S, CWK605502S, CWK604624S, CWK604625S, CWK604396S, CWK605478S, CWK604413S, CWK604933S, CWK605391S, CWK601948S, CWK601949S, CWK601950S, CWK601953S, CWK601961S, CWK601965S, CWK601966S, CWK601970S, CWK601971S, CWK601972S, CWK601974S, CWK601976S, CWK602568S, CWK602617S, CWK602627S, CWK602632S, CWK602691S, CWK602827S, CWK602843S, CWK602870S, CWK601348S, CWK603369S, CWK604247S, CWK604852S, CWK603773S, CWK601726S, CWK601802S, CWK602031S, CWK602325S, CWK602330S, CWK602332S, CWK602336S, CWK602338S, CWK602339S, CWK602355S, CWK602357S, CWK602577S, CWK602645S, CWK602652S, CWK603257S, CWK603258S, CWK603319S, CWK603334S, CWK603926S, CWK603957S, CWK603969S, CWK604118S, CWK604120S, CWK604127S, CWK604307S, CWK604310S, CWK604313S, CWK604321S, CWK605197S, CWK605198S, CWK605207S, CWK605208S, CWK605209S, CWK605210S, CWK605211S, CWK605212S, CWK605449S, CWK605470S, CWK605473S, CWK603235S, CWK603237S, CWK603242S, CWK601913S, CWK602871S, CWK603546S, CWK604544S, CWK604577S, CWK604848S, CWK602774S, CWK603194S, CWK604685S, CWK602551S, CWK604090S, CWK603535S, CWK603951S, CWK601375S, CWK602172S, CWK602462S, CWK602548S, CWK602639S, CWK602643S, CWK602649S, CWK602858S, CWK603058S, CWK603090S, CWK603249S, CWK603289S, CWK6032
00763000001520
Official record: FDA (Device enforcement) ↗
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