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: 1930 units Lot/code info: GTIN 00763000178499, Lot Serial Numbers: RSE600116S, RSE600346S, RSE600428S, RSE600572S, RSE600505S, RSE600512S, RSE600513S, RSE600515S, RSE600517S, RSE600518S, RSE600519S, RSE600520S, RSE601603S, RSE601609S, RSE601846S, RSE601849S, RSE601856S, RSE601872S, RSE601873S, RSE602612S, RSE600806S, RSE601469S, RSE600412S, RSE600554S, RSE602156S, RSE602245S, RSE602658S, RSE601353S, RSE600764S, RSE602060S, RSE600993S, RSE602062S, RSE602445S, RSE600734S, RSE601371S, RSE602291S, RSE602297S, RSE600746S, RSE601898S, RSE602099S, RSE600431S, RSE600674S, RSE601618S, RSE601619S, RSE601620S, RSE601621S, RSE601622S, RSE600190S, RSE600193S, RSE601209S, RSE601330S, RSE601355S, RSE601504S, RSE600672S, RSE602161S, RSE601259S, RSE602483S, RSE602484S, RSE600831S, RSE601521S, RSE602381S, RSE600466S, RSE602661S, RSE601694S, RSE602144S, RSE601665S, RSE600452S, RSE601575S, RSE602255S, RSE600158S, RSE601717S, RSE601721S, RSE601724S, RSE600285S, RSE601560S, RSE601774S, RSE601962S, RSE602295S, RSE600579S, RSE602177S, RSE600272S, RSE602293S, RSE602416S, RSE602070S, RSE602117S, RSE602173S, RSE602183S, RSE602314S, RSE602597S, RSE600621S, RSE602513S, RSE600290S, RSE600424S, RSE600681S, RSE602573S, RSE600323S, RSE600675S, RSE601667S, RSE602071S, RSE601954S, RSE602353S, RSE600303S, RSE600294S, RSE602143S, RSE601789S, RSE600800S, RSE602098S, RSE600774S, RSE601385S, RSE602215S, RSE600345S, RSE600098S, RSE600197S, RSE600390S, RSE600603S, RSE600646S, RSE600827S, RSE600832S, RSE601468S, RSE601548S, RSE601929S, RSE6002
00763000178499, 00763000178505
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.