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: 2282 units Lot/code info: GTIN 00643169217911, Lot Serial Numbers: BWE613480S, BWE613110S, BWE613432S, BWE613202S, BWE613100S, BWE613096S, BWE613185S, BWE613258S, BWE613431S, BWE612802S, BWE612865S, BWE613214S, BWE613235S, BWE612884S, BWE612956S, BWE613098S, BWE613122S, BWE613143S, BWE613171S, BWE613212S, BWE613216S, BWE613251S, BWE613470S, BWE613162S, BWE613238S, BWE613459S, BWE613430S, BWE613153S, BWE613484S, BWE613168S, BWE612948S, BWE612950S, BWE612970S, BWE613487S, BWE613090S, BWE613224S, BWE613180S, BWE613077S, BWE612815S, BWE612940S, BWE613086S, BWE612721S, BWE613194S, BWE612880S, BWE613125S, BWE613221S, BWE612822S, BWE612985S, BWE612928S, BWE613446S, BWE612939S, BWE612837S, BWE613097S, BWE613095S, BWE613104S, BWE613211S, BWE613463S, BWE613460S, BWE612679S, BWE612960S, BWE613149S, BWE613150S, BWE613247S, BWE612981S, BWE612987S, BWE613145S, BWE613147S, BWE613485S, BWE612986S, BWE613443S, BWE612844S, BWE612686S, BWE612824S, BWE612853S, BWE612923S, BWE612976S, BWE612935S, BWE612982S, BWE612993S, BWE613155S, BWE613124S, BWE612930S, BWE612949S, BWE612833S, BWE613115S, BWE613182S, BWE613121S, BWE612922S, BWE612990S, BWE613197S, BWE612801S, BWE612988S, BWE613111S, BWE613116S, BWE613146S, BWE613183S, BWE613352S, BWE613141S, BWE613466S, BWE612675S, BWE612785S, BWE612796S, BWE612961S, BWE613089S, BWE613101S, BWE613250S, BWE613253S, BWE613448S, BWE613467S, BWE612978S, BWE612685S, BWE612974S, BWE612876S, BWE612917S, BWE612977S, BWE613082S, BWE613102S, BWE613156S, BWE613441S, BWE613444S, BWE613473S, BWE6131
00643169217911, 00643169969568, 00643169980204
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.