Medtronic recalls CRT-D DTBA2D1 VIVA XT devices with specific serial numbers due to rare risk of reduced or no energy output during high voltage therapy. This may affect device function but is not common.
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 certain implantable cardioverter defibrillators (CRT-Ds) that may have a rare issue causing reduced or no energy output during high voltage therapy. This could potentially lead to device malfunction but is uncommon.
The device uses a glassed feedthrough that can sometimes cause reduced or no energy output during high voltage therapy (typically 0-12J). This is a rare occurrence and does not typically cause harm.
People with Medtronic CRT-D DTBA2D1 VIVA XT devices manufactured with a specific glassed feedthrough. Most users are not at risk as this is a rare issue.
Check your device's model number (DTBA2D1), and serial numbers listed in the recall (e.g., BLJ622286S, BLJ622571S). The GTIN is 00643169217959 or 00643169720343.
Look for the serial numbers listed in the recall (e.g., BLJ622286S, BLJ622571S) on your device's label.
If your device is affected, contact Medtronic directly for further instructions.
This is a rare issue that may cause reduced or no energy output during high voltage therapy. It is not common and does not typically cause harm.
Check your device's model number (DTBA2D1) and serial number against the list of affected serial numbers provided in the recall.
No action is needed if your device is not on the list of affected serial numbers.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1735-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1735-2023 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.
