Medtronic recalls specific models of CRT-D defibrillators (DTBA1Q1) due to rare risk of reduced or no energy output during high voltage therapy. Affected devices may need replacement.
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 defibrillators (model DTBA1Q1) because they have a rare risk of not delivering enough energy during high voltage therapy. This could potentially lead to ineffective treatment of heart conditions.
The recalled devices use a specific glassed feedthrough that can occasionally fail to deliver sufficient energy during high voltage therapy (typically 0-12 joules). This rare issue might not cause serious harm but could lead to ineffective treatment of heart conditions.
People with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) using the recalled model DTBA1Q1 are affected. Those with heart conditions requiring these devices are most at risk.
Check if your device has the model number DTBA1Q1 and the listed serial numbers (e.g., BLD212440H). The product is sold as a CRT-D VIVA QUAD XT IS4/DF1 in the US.
Look for the model number DTBA1Q1 on your device's label or documentation.
Reach out to Medtronic directly to confirm if your device is affected and get instructions for replacement.
The recall describes a rare potential for reduced or no energy output during high voltage therapy, which could lead to ineffective treatment but is not typically life-threatening.
Check for the model number DTBA1Q1 and the specific serial numbers listed in the recall notice.
Contact Medtronic directly to determine if your device is affected and get instructions for replacement.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1732-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1732-2023 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.