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: 476 units Lot/code info: GTIN 00763000178291, Lot Serial numbers: RTW600585S, RTW600307S, RTW600091S, RTW600313S, RTW600121S, RTW600342S, RTW600596S, RTW600074S, RTW600144S, RTW600102S, RTW600319S, RTW600578S, RTW600346S, RTW600277S, RTW600309S, RTW600581S, RTW600098S, RTW600118S, RTW600119S, RTW600123S, RTW600133S, RTW600138S, RTW600159S, RTW600168S, RTW600205S, RTW600052S, RTW600067S, RTW600217S, RTW600333S, RTW600592S, RTW600059S, RTW600151S, RTW600169S, RTW600196S, RTW600229S, RTW600304S, RTW600306S, RTW600223S, RTW600062S, RTW600171S, RTW600049S, RTW600057S, RTW600126S, RTW600130S, RTW600153S, RTW600158S, RTW600163S, RTW600181S, RTW600182S, RTW600188S, RTW600204S, RTW600211S, RTW600230S, RTW600240S, RTW600245S, RTW600247S, RTW600249S, RTW600250S, RTW600317S, RTW600323S, RTW600338S, RTW600588S, RTW600589S, RTW600593S, RTW600339S, RTW600819S, RTW600113S, RTW600594S, RTW600120S, RTW600244S, RTW600008S, RTW600056S, RTW600089S, RTW600183S, RTW600239S, RTW600292S, RTW600297S, RTW600069S, RTW600148S, RTW600080S, RTW600156S, RTW600179S, RTW600094S, RTW600127S, RTW600161S, RTW600813S, RTW600068S, RTW600110S, RTW600149S, RTW600237S, RTW600345S, RTW600591S, RTW600082S, RTW600087S, RTW600090S, RTW600350S, RTW600358S, RTW600362S, RTW600363S, RTW600365S, RTW600054S, RTW600075S, RTW600347S, RTW600619S, RTW600620S, RTW600624S, RTW600625S, RTW600628S, RTW600630S, RTW600634S, RTW600637S, RTW600640S, RTW600641S, RTW600643S, RTW600648S, RTW600649S, RTW600650S, RTW600651S, RTW600654S, RTW600655S, RTW600658S, RTW6006
00763000178291, 00763000178314
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.