Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; 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: 3 units Lot/code info: GTIN 00763000446048, lot serial Numbers: RTH601150S, RTH601151S; GTIN 00763000718732, Lot Serial Numbers: RTH603584S

UPC codes

00763000446048, 00763000718732

Source

Official record: FDA (Device enforcement) ↗

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