Medtronic recalls CRT-D VIVA QUAD XT Gold CTD devices (model DTBA2QQG) due to rare risk of reduced defibrillator energy during high voltage therapy. Affected units have specific serial numbers and lot codes.
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 Gold CTD defibrillators because they may not deliver proper energy during high voltage therapy. This could potentially lead to inadequate treatment for heart conditions if the device fails to function correctly.
The recalled devices use a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. This could result in the device failing to deliver necessary shocks for heart rhythm management during critical events.
Patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) using the recalled model are affected. Those with specific serial numbers and lot codes are most at risk.
Check for the model number DTBA2QQG on the device label. Affected units have lot serial numbers starting with BLG626306S and GTIN 00643169518223.
Look for the model number DTBA2QQG and lot serial numbers starting with BLG626306S on the device.
The recalled model number is DTBA2QQG.
The device may not deliver proper energy during high voltage therapy, potentially leading to inadequate treatment for heart conditions.
Check for the model number DTBA2QQG and lot serial numbers starting with BLG626306S on the device label.
We’ve drafted a message you can send Medtr: Cardiac Rhythm to request your refund or repair — edit it as you like.
Subject: Recall Z-1740-2023 — Medtr: Cardiac Rhythm Medtr: Cardiac Rhythm Hello, I own a Medtr: Cardiac Rhythm that is covered by recall Z-1740-2023 from Medtr: Cardiac Rhythm. 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.