Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; 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: 9 units Lot/code info: GTIN 00763000501020, Lot Serial Numbers: RTC614024S, RTC617998S, RTC614026S, RTC617999S, RTC618002S, RTC618007S, RTC621332S, RTC614023S, RTC611661S

UPC codes

00763000501020

Source

Official record: FDA (Device enforcement) ↗

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