Medtronic recalls certain implantable cardioverter defibrillators (CRTDs) due to rare potential for reduced or no energy output during high voltage therapy. Affected models include VIVA XT IS1 DF1 OUS GOLD with specific serial numbers.
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.
Medtronic is recalling specific models of implantable cardioverter defibrillators (CRTDs) that have a rare risk of not delivering enough energy during high-voltage therapy. This could potentially lead to ineffective treatment in some cases.
The recalled CRTDs have a specific type of glassed feedthrough that can cause reduced or no energy output during high voltage therapy. This means the device might not work properly when needed to treat heart conditions.
People with implanted cardioverter defibrillators (CRTDs) using the recalled models are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check if your device is labeled as VIVA XT IS1 DF1 OUS GOLD with model number DTBA2D1G. Look for serial numbers starting with BLJ622585S, BLJ622586S, BLJ622587S, BLJ622075S, BLJ622076S, BLJ623836S, BLJ623837S, or BLJ623838S.
Look for the model number DTBA2D1G and serial numbers starting with BLJ622585S through BLJ623838S on your device.
The recall describes a rare potential for reduced or no energy output during high voltage therapy, but it is not a common hazard. The risk is low.
Check for the model number DTBA2D1G and serial numbers starting with BLJ622585S through BLJ623838S on your device label.
The recall does not specify a remedy, so you should contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1736-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1736-2023 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.