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: 2031 units Lot/code info: GTIN 00763000178550. Lot Serial Numbers: RSH600068S, RSH600173S, RSH600239S, RSH601126S, RSH601127S, RSH601883S, RSH601888S, RSH601444S, RSH601463S, RSH601537S, RSH601538S, RSH600064S, RSH600099S, RSH600174S, RSH600175S, RSH600228S, RSH600275S, RSH600276S, RSH600889S, RSH600903S, RSH601415S, RSH601522S, RSH601873S, RSH600071S, RSH600906S, RSH600922S, RSH601034S, RSH601041S, RSH601123S, RSH600007S, RSH600082S, RSH600110S, RSH601765S, RSH601894S, RSH600236S, RSH600264S, RSH601531S, RSH600057S, RSH600124S, RSH600181S, RSH600211S, RSH600827S, RSH600887S, RSH601024S, RSH601036S, RSH601366S, RSH600902S, RSH601519S, RSH601520S, RSH601751S, RSH601753S, RSH601754S, RSH601805S, RSH600814S, RSH601139S, RSH601355S, RSH601407S, RSH600147S, RSH600101S, RSH601443S, RSH601460S, RSH601462S, RSH601535S, RSH601536S, RSH601539S, RSH601542S, RSH600041S, RSH600045S, RSH600055S, RSH600066S, RSH600067S, RSH600086S, RSH600097S, RSH600102S, RSH600103S, RSH600108S, RSH600109S, RSH600117S, RSH600126S, RSH600130S, RSH600142S, RSH600145S, RSH600157S, RSH600188S, RSH600199S, RSH600204S, RSH600207S, RSH600222S, RSH600225S, RSH600240S, RSH600829S, RSH601023S, RSH601058S, RSH600169S, RSH600171S, RSH600172S, RSH600815S, RSH601129S, RSH600238S, RSH601431S, RSH601540S, RSH601761S, RSH600135S, RSH600219S, RSH600821S, RSH600849S, RSH600921S, RSH601749S, RSH600132S, RSH600262S, RSH600911S, RSH601030S, RSH601742S, RSH600205S, RSH601728S, RSH601730S, RSH601796S, RSH601863S, RSH600170S, RSH600820S, RSH601914S, RSH6019
00763000178550, 00763000178567
Official record: FDA (Device enforcement) ↗
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