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: 27788 Units Lot/code info: GTIN 00763000178093, Lot Serial Numbers: RTC605498S, RTC605500S, RTC605501S, RTC605502S, RTC607884S, RTC607885S, RTC608196S, RTC608199S, RTC608200S, RTC610884S, RTC610885S, RTC610887S, RTC610889S, RTC610890S, RTC610892S, RTC626989S, RTC626991S, RTC626992S, RTC626996S, RTC604820S, RTC605664S, RTC606411S, RTC606605S, RTC613019S, RTC613629S, RTC614078S, RTC612708S, RTC614277S, RTC611123S, RTC611127S, RTC611128S, RTC613158S, RTC613159S, RTC613160S, RTC613162S, RTC613164S, RTC613165S, RTC613166S, RTC626776S, RTC626778S, RTC626780S, RTC612365S, RTC612540S, RTC612629S, RTC614220S, RTC600235S, RTC600300S, RTC600381S, RTC600573S, RTC602541S, RTC602726S, RTC605274S, RTC605795S, RTC607215S, RTC607469S, RTC608981S, RTC609490S, RTC610107S, RTC610867S, RTC613560S, RTC614081S, RTC600433S, RTC600555S, RTC600556S, RTC600576S, RTC600703S, RTC604519S, RTC605238S, RTC605983S, RTC606093S, RTC606096S, RTC607001S, RTC607069S, RTC607165S, RTC607228S, RTC607497S, RTC609933S, RTC609934S, RTC614263S, RTC616913S, RTC626571S, RTC626741S, RTC626744S, RTC600227S, RTC600446S, RTC600738S, RTC602429S, RTC602521S, RTC602532S, RTC602562S, RTC602581S, RTC602606S, RTC602647S, RTC602760S, RTC603157S, RTC604487S, RTC604489S, RTC604490S, RTC604517S, RTC604868S, RTC604869S, RTC604870S, RTC604873S, RTC604994S, RTC605153S, RTC605262S, RTC605346S, RTC605488S, RTC607041S, RTC607045S, RTC607227S, RTC607784S, RTC608747S, RTC608782S, RTC608850S, RTC608853S, RTC608856S, RTC609927S, RTC609929S, RTC610185S, RTC610675S, RTC6117
00763000178093
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.