Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators

Hazard

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.

Details from the source

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: 10197 units Lot/code info: GTIN 00643169837652, Lot Serial Numbers: RPR605458S, RPR606698S, RPR605664S, RPR602262S, RPR601954S, RPR602352S, RPR602691S, RPR602236S, RPR601128S, RPR601184S, RPR601760S, RPR603209S, RPR603275S, RPR603699S, RPR605742S, RPR605761S, RPR605767S, RPR605779S, RPR605784S, RPR605787S, RPR605804S, RPR605808S, RPR605811S, RPR605818S, RPR606116S, RPR606117S, RPR606122S, RPR606123S, RPR606127S, RPR606128S, RPR606138S, RPR606140S, RPR606272S, RPR606276S, RPR606278S, RPR606279S, RPR606285S, RPR606289S, RPR607179S, RPR607180S, RPR607181S, RPR607182S, RPR607183S, RPR607184S, RPR607185S, RPR607187S, RPR607188S, RPR607525S, RPR606331S, RPR607064S, RPR607604S, RPR607373S, RPR604676S, RPR605390S, RPR605391S, RPR607439S, RPR602589S, RPR602608S, RPR602612S, RPR602645S, RPR602882S, RPR602940S, RPR602941S, RPR602944S, RPR602946S, RPR602951S, RPR603067S, RPR603252S, RPR603254S, RPR603744S, RPR603758S, RPR603759S, RPR603891S, RPR603892S, RPR603894S, RPR604007S, RPR604025S, RPR604173S, RPR604233S, RPR604234S, RPR604235S, RPR604236S, RPR604237S, RPR604238S, RPR604302S, RPR604308S, RPR604320S, RPR604326S, RPR604354S, RPR604559S, RPR604560S, RPR604678S, RPR604679S, RPR604681S, RPR605666S, RPR605668S, RPR605899S, RPR605970S, RPR605971S, RPR606043S, RPR606048S, RPR606265S, RPR606308S, RPR606336S, RPR606342S, RPR606345S, RPR606348S, RPR606414S, RPR606497S, RPR606502S, RPR606714S, RPR606722S, RPR606910S, RPR606918S, RPR606960S, RPR607578S, RPR602225S, RPR602222S, RPR602233S, RPR602478S, RPR602191S, RPR6022

UPC codes

00643169837652

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.