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: 8575 units Lot/code info: GTIN 00643169720725, Lot Serial Numbers: RPK603310S, RPK606030S, RPK607323S, RPK606692S, RPK605552S, RPK604274S, RPK607156S, RPK607510S, RPK606721S, RPK606379S, RPK606753S, RPK603895S, RPK607997S, RPK608001S, RPK608115S, RPK602608S, RPK602842S, RPK602915S, RPK603155S, RPK603438S, RPK603475S, RPK604209S, RPK604230S, RPK604885S, RPK605001S, RPK605994S, RPK606046S, RPK606664S, RPK607134S, RPK608665S, RPK604002S, RPK604373S, RPK605499S, RPK605680S, RPK603963S, RPK607543S, RPK607544S, RPK607943S, RPK608088S, RPK608203S, RPK607149S, RPK607416S, RPK607418S, RPK607615S, RPK608212S, RPK608297S, RPK608298S, RPK609062S, RPK604646S, RPK605555S, RPK605685S, RPK606797S, RPK604171S, RPK605262S, RPK605291S, RPK605292S, RPK606475S, RPK607086S, RPK603372S, RPK603375S, RPK603380S, RPK603962S, RPK604174S, RPK604351S, RPK604536S, RPK604651S, RPK604654S, RPK604869S, RPK604972S, RPK604973S, RPK605109S, RPK605214S, RPK605233S, RPK605272S, RPK606024S, RPK606053S, RPK606141S, RPK606473S, RPK606792S, RPK606817S, RPK606853S, RPK607088S, RPK607422S, RPK607441S, RPK607442S, RPK607443S, RPK607620S, RPK607647S, RPK607857S, RPK607865S, RPK607972S, RPK608102S, RPK608939S, RPK604642S, RPK604644S, RPK604989S, RPK607684S, RPK608101S, RPK608890S, RPK603423S, RPK603908S, RPK604177S, RPK604228S, RPK604660S, RPK604981S, RPK605848S, RPK606143S, RPK606525S, RPK606535S, RPK607423S, RPK607911S, RPK607917S, RPK607918S, RPK604191S, RPK606048S, RPK606472S, RPK606793S, RPK606813S, RPK606816S, RPK607922S, RPK604227S, RPK6043
00643169720725
Official record: FDA (Device enforcement) ↗
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