Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; 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: 5 units Lot/code info: GTIN 00763000501044, lot serial Numbers: RTH602452S, RTH602446S, RTH602443S, RTH602454S, RTH602442S

UPC codes

00763000501044

Source

Official record: FDA (Device enforcement) ↗

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