Medtronic recalls CRT-D DTBA2Q1 VIVA QUAD XT models with specific serial numbers due to rare risk of reduced or no energy output during high voltage therapy. No immediate action needed for most users.
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 CRT-D VIVA QUAD XT models (DTBA2Q1) that may have a rare issue causing reduced or no energy output during high voltage therapy. This could affect the device's ability to treat heart conditions, but the risk is very low and not all users are impacted.
The device uses a specific glassed feedthrough that may occasionally fail to deliver proper energy during high voltage therapy (0-12J). This could reduce or stop the device's ability to treat heart conditions, but the risk is very low and only occurs in rare cases.
People with Medtronic CRT-D VIVA QUAD XT implants (model DTBA2Q1) and their healthcare providers. Most users are not at risk as the issue is rare and only affects specific models.
Check if your device has the model number DTBA2Q1 and the specific serial numbers listed in the recall notice. The recall covers certain GTINs and serial numbers provided in the document.
Verify your device's model number is DTBA2Q1 and check if it matches the serial numbers listed in the recall notice.
The recall states there is a rare potential for reduced or no energy output during high voltage therapy, but it is not a common or immediate danger. Most users are not affected.
The recall does not specify a remedy, so no action is needed unless your device matches the model and serial numbers listed.
Check your device's model number (DTBA2Q1) and compare it to the specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1738-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1738-2023 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.
