Medtronic recalls certain CRT-D devices (model DTBB1QQ) that may have reduced or no energy output during high voltage therapy, potentially affecting heart rhythm treatment.
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 specific models of implantable cardioverter defibrillators (CRT-Ds) that may not deliver proper energy during high voltage therapy. This could lead to ineffective heart rhythm treatment in patients using these devices.
The recalled devices use a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy (typically 0-12J). This could result in the device failing to treat heart rhythm issues as intended.
Patients with Medtronic CRT-D devices (model DTBB1QQ) who have been implanted with the recalled devices are affected. Those with the specific lot/serial numbers listed in the recall are at risk of reduced therapy effectiveness.
Check your device's model number (DTBB1QQ) and lot/serial numbers against the list provided in the recall. The devices are labeled as 'VIVA QUAD S IS4/DF4 US' and have specific serial numbers starting with BLK205...
Identify your device's model number and lot/serial numbers to see if they match the recalled list.
Reach out to Medtronic directly for guidance on next steps if your device is affected.
The recalled devices have model number DTBB1QQ (VIVA QUAD S IS4/DF4 US).
Compare your device's lot/serial numbers with the list of BLK205... numbers provided in the recall.
Contact Medtronic directly for guidance on next steps, as the recall does not specify a replacement or repair process.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1744-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1744-2023 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.