medical Class I Updated 2023-06-28

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1

Recalled Product

CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN 00763000071431, Lot Serial Numbers: BLJ622587S, BLJ622075S, BLJ622585S, BLJ623836S, BLJ622076S, BLJ623838S, BLJ622586S, BLJ623837S
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →