Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; 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: 8 units Lot/code info: GTIN 00763000071431, Lot Serial Numbers: BLJ622587S, BLJ622075S, BLJ622585S, BLJ623836S, BLJ622076S, BLJ623838S, BLJ622586S, BLJ623837S

UPC codes

00763000071431

Source

Official record: FDA (Device enforcement) ↗

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