Medtronic recalls CRT-D VIVA XT DTBA1D1 models with specific glassed feedthroughs. These devices may have reduced or no energy output during high voltage therapy, potentially causing ineffective heart rhythm treatment. Affected units include specific lot/serial numbers listed in the recall.
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 VIVA XT CRT-D defibrillators that use a specific glassed feedthrough. These devices may not deliver proper energy during high voltage therapy, which could lead to ineffective heart rhythm treatment. This is a rare potential issue.
The device uses a glassed feedthrough that may cause reduced or no energy output during high voltage therapy (typically 0-12J). This could lead to ineffective heart rhythm treatment if the device fails to deliver the required energy during critical medical events.
People with Medtronic CRT-D VIVA XT DTBA1D1 defibrillators manufactured with the specific glassed feedthrough. Most users are likely unaffected as this is a rare potential issue.
Check if your device has the model number DTBA1D1 and the specific lot/serial numbers listed in the recall (e.g., BLF258142H, BLF257918H, etc.). The GTIN is 00643169720312.
Verify your device has model number DTBA1D1 and the specific lot/serial numbers listed in the recall.
Reach out to Medtronic for guidance on next steps if your device is affected.
This is a rare potential issue that may cause reduced or no energy output during high voltage therapy, but it does not cause immediate harm or injury.
Check if your device has model number DTBA1D1 and the specific lot/serial numbers listed in the recall (e.g., BLF258142H, BLF257918H, etc.).
Contact Medtronic for guidance on next steps, which may include device replacement or repair.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1729-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1729-2023 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.