Medtronic recalls CRT-D DTBA2QQ VIVA QUAD XT devices with specific serial numbers due to rare risk of reduced or no energy output during high voltage therapy, which could affect heart rhythm management.
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) with model number DTBA2QQ. These devices have a rare risk of not delivering proper energy during high-voltage therapy, which could lead to ineffective heart rhythm treatment. This is a potential safety issue for patients with these devices.
The device uses a specific glassed feedthrough that can occasionally fail to deliver adequate energy during high-voltage therapy (0-12J). This may result in reduced or no energy output, potentially compromising the device's ability to treat heart rhythm issues.
Patients with Medtronic CRT-D DTBA2QQ VIVA QUAD XT implantable cardioverter defibrillators. Most users are likely to be patients with heart conditions requiring this device.
Check if your device has model number DTBA2QQ and serial numbers listed in the recall (e.g., BLG624311S, BLG625177S, etc.). The device is identified by the GTIN 00643169720169.
Identify your device model as DTBA2QQ VIVA QUAD XT IS4/DF4 INTL.
Confirm your device's serial number matches the list provided in the recall (e.g., BLG624311S, BLG625177S).
This recall involves a rare potential for reduced or no energy output during high-voltage therapy, which could affect heart rhythm management. However, the risk is low and not expected to cause serious injury in normal use.
Check if your device has model number DTBA2QQ and serial numbers listed in the recall (e.g., BLG624311S, BLG625177S). The device is identified by GTIN 00643169720169.
The recall does not require immediate action. Patients with affected devices should check their serial numbers against the list provided and contact Medtronic if they are unsure.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1739-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1739-2023 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.
