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: 1354 units Lot/code info: GTIN 00643169218017, Lot Serial numbers: BWK607537S, BWK607358S, BWK607401S, BWK607460S, BWK607496S, BWK607540S, BWK607351S, BWK607371S, BWK607254S, BWK607394S, BWK607446S, BWK607457S, BWK607473S, BWK607498S, BWK607503S, BWK607536S, BWK607381S, BWK607393S, BWK607369S, BWK607474S, BWK607432S, BWK607439S, BWK607523S, BWK607448S, BWK607526S, BWK607383S, BWK607434S, BWK607463S, BWK607360S, BWK607437S, BWK607472S, BWK607451S, BWK607449S, BWK607436S, BWK607527S, BWK607361S, BWK607275S, BWK607326S, BWK607343S, BWK607384S, BWK607391S, BWK607479S, BWK607501S, BWK607507S, BWK607508S, BWK607518S, BWK607520S, BWK607535S, BWK607544S, BWK607327S, BWK607379S, BWK607521S, BWK607382S, BWK607502S, BWK607366S, BWK607386S, BWK607441S, BWK607468S, BWK607497S, BWK607465S, BWK607455S, BWK607470S, BWK607376S, BWK607529S, BWK607456S, BWK607509S, BWK607505S, BWK607378S, BWK607444S, BWK607297S, BWK607348S, BWK607447S, BWK607395S, BWK607464S, BWK607485S, BWK607534S, BWK607442S, BWK607347S, BWK607389S, BWK607400S, BWK607370S, BWK607438S, BWK607323S, BWK607495S, BWK607519S, BWK607368S, BWK607278S, BWK607433S, BWK607367S, BWK607499S, BWK607349S, BWK607356S, BWK607440S, BWK607458S, BWK607517S, BWK607459S, BWK607392S, BWK607450S, BWK607466S, BWK607342S, BWK607510S, BWK607445S, BWK607500S, BWK607515S, BWK607514S, BWK607533S, BWK607274S, BWK607281S, BWK607377S, BWK607506S, BWK607294S, BWK607471S, BWK607346S, BWK607307S, BWK607504S, BWK607435S, BWK607443S, BWK607399S; GTIN 00643169969582, Lot Serial Numbers: BW
00643169218017, 00643169969582, 00643169980242
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.