Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; 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: 462 units Lot/code info: GTIN 00763000178307, Lot Serial numbers: RTX600076S, RTX600084S, RTX600139S, RTX600148S, RTX600114S, RTX600308S, RTX600386S, RTX600327S, RTX600334S, RTX600372S, RTX600046S, RTX600048S, RTX600066S, RTX600108S, RTX600261S, RTX600345S, RTX600586S, RTX600382S, RTX600388S, RTX600064S, RTX600069S, RTX600096S, RTX600377S, RTX600360S, RTX600581S, RTX600158S, RTX600306S, RTX600713S, RTX600100S, RTX600319S, RTX600594S, RTX600720S, RTX600727S, RTX600045S, RTX600153S, RTX600157S, RTX600326S, RTX600081S, RTX600146S, RTX600055S, RTX600058S, RTX600143S, RTX600314S, RTX600323S, RTX600332S, RTX600344S, RTX600693S, RTX600307S, RTX600310S, RTX600317S, RTX600588S, RTX600705S, RTX600072S, RTX600095S, RTX600147S, RTX600695S, RTX600698S, RTX600309S, RTX600792S, RTX600167S, RTX600807S, RTX600387S, RTX600086S, RTX600322S, RTX600343S, RTX600365S, RTX600091S, RTX600124S, RTX600597S, RTX600688S, RTX600689S, RTX600799S, RTX600800S, RTX600085S, RTX600087S, RTX600312S, RTX600019S, RTX600120S, RTX600137S, RTX600260S, RTX600370S, RTX600391S, RTX600724S, RTX600149S, RTX600596S, RTX600159S, RTX600700S, RTX600692S, RTX600170S, RTX600697S, RTX600587S, RTX600330S, RTX600256S, RTX600369S, RTX600394S, RTX600398S, RTX600591S, RTX600592S, RTX600690S, RTX600350S, RTX600363S, RTX600589S, RTX600257S, RTX600276S, RTX600277S, RTX600321S, RTX600346S, RTX600354S, RTX600356S, RTX600402S, RTX600481S, RTX600065S, RTX600205S, RTX600210S, RTX600264S, RTX600348S, RTX600351S, RTX600732S, RTX600735S, RTX600743S, RTX600746S, RTX6007

UPC codes

00763000178307, 00763000178321

Source

Official record: FDA (Device enforcement) ↗

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