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: 2000 units Lot/code info: GTIN 00763000178451, Lot Serial Numbers: RSC601940S, RSC601072S, RSC601241S, RSC600327S, RSC601396S, RSC602028S, RSC602030S, RSC602031S, RSC602036S, RSC600018S, RSC602529S, RSC602530S, RSC602531S, RSC602532S, RSC600347S, RSC600391S, RSC600419S, RSC601490S, RSC602703S, RSC600337S, RSC600420S, RSC600421S, RSC600422S, RSC600423S, RSC600501S, RSC601410S, RSC601433S, RSC602269S, RSC601444S, RSC601446S, RSC602764S, RSC602765S, RSC600131S, RSC600281S, RSC600298S, RSC601388S, RSC602497S, RSC600174S, RSC602387S, RSC601415S, RSC602106S, RSC600225S, RSC600240S, RSC601647S, RSC602710S, RSC601960S, RSC601961S, RSC602209S, RSC602257S, RSC602306S, RSC602379S, RSC602473S, RSC600293S, RSC600299S, RSC600328S, RSC601071S, RSC601345S, RSC601443S, RSC601450S, RSC601632S, RSC601887S, RSC602213S, RSC602144S, RSC602234S, RSC601419S, RSC602168S, RSC600147S, RSC600417S, RSC601631S, RSC600275S, RSC601999S, RSC602394S, RSC602701S, RSC602752S, RSC602620S, RSC600443S, RSC602061S, RSC602064S, RSC602068S, RSC602072S, RSC602073S, RSC602075S, RSC602076S, RSC602433S, RSC601216S, RSC601221S, RSC601222S, RSC601223S, RSC601227S, RSC601228S, RSC601229S, RSC601230S, RSC601231S, RSC601532S, RSC601534S, RSC601537S, RSC601538S, RSC601541S, RSC601543S, RSC601545S, RSC601547S, RSC601551S, RSC601552S, RSC601553S, RSC601554S, RSC601577S, RSC601578S, RSC601579S, RSC601581S, RSC601848S, RSC601849S, RSC601850S, RSC601851S, RSC601852S, RSC602062S, RSC602335S, RSC602430S, RSC602431S, RSC602432S, RSC602434S, RSC601022S, RSC6011
00763000178451, 00763000178475, 00763000380380
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.