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: 4546 units Lot/code info: GTIN 00643169837805, Lot Serial Numbers: CWH604762S, CWH602704S, CWH604287S, CWH601113S, CWH602355S, CWH601417S, CWH601422S, CWH601423S, CWH603581S, CWH602459S, CWH602700S, CWH601632S, CWH601887S, CWH602686S, CWH602952S, CWH603048S, CWH604506S, CWH604849S, CWH605365S, CWH605366S, CWH605549S, CWH602311S, CWH603176S, CWH603389S, CWH601114S, CWH601326S, CWH601494S, CWH601599S, CWH601907S, CWH601934S, CWH602005S, CWH602031S, CWH602068S, CWH602379S, CWH602640S, CWH602643S, CWH602875S, CWH602966S, CWH603029S, CWH603161S, CWH603186S, CWH604179S, CWH604365S, CWH604848S, CWH605143S, CWH605152S, CWH605229S, CWH605231S, CWH601040S, CWH601241S, CWH602091S, CWH602139S, CWH602556S, CWH602717S, CWH603107S, CWH603227S, CWH603322S, CWH603327S, CWH603472S, CWH603986S, CWH604007S, CWH604304S, CWH604619S, CWH604856S, CWH604885S, CWH604939S, CWH604949S, CWH605132S, CWH605170S, CWH605306S, CWH605355S, CWH605386S, CWH605421S, CWH605553S, CWH601042S, CWH601324S, CWH601385S, CWH601970S, CWH602573S, CWH603036S, CWH603079S, CWH603431S, CWH603434S, CWH603477S, CWH603821S, CWH603840S, CWH603953S, CWH604240S, CWH604483S, CWH604632S, CWH604921S, CWH604975S, CWH605095S, CWH605179S, CWH605357S, CWH605359S, CWH605422S, CWH601010S, CWH601803S, CWH601935S, CWH601972S, CWH602411S, CWH602435S, CWH602708S, CWH602709S, CWH603306S, CWH603642S, CWH604021S, CWH604115S, CWH604160S, CWH604301S, CWH604344S, CWH604451S, CWH604587S, CWH604732S, CWH604811S, CWH604842S, CWH604918S, CWH604946S, CWH605157S, CWH605546S, CWH6055
00643169837805
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.