Medtronic recalls CRT-D DTBA1D4 VIVA XT IS1/DF4 US models with specific glassed feedthroughs due to rare risk of reduced or no energy output during high voltage therapy.
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 XT defibrillators that may have a rare issue causing reduced or no energy output during high voltage therapy. This could potentially affect the device's ability to treat heart conditions.
The device uses a specific type of glassed feedthrough that can occasionally fail to deliver proper energy during high voltage therapy (typically 0-12 joules). This rare issue may cause the device to not function correctly when needed for heart treatment.
People with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) that were implanted with the recalled model. Those who have the specific model number DTBA1D4 and lot/serial numbers listed in the recall are most at risk.
Check if your device is a Medtronic CRT-D VIVA XT model with serial numbers starting with BLE221... or BLE221... (the full list of serial numbers is provided in the recall).
Look for the model number DTBA1D4 on your device's label or documentation.
Reach out to Medtronic directly to confirm if your device is affected and get instructions for next steps.
This is a rare issue that may cause reduced or no energy output during high voltage therapy, but it does not typically cause serious injury or death.
Check if your device has the model number DTBA1D4 and one of the specific serial numbers listed in the recall.
Contact Medtronic directly to confirm your device's status and get instructions for next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1731-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1731-2023 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.
