Medtronic recalls certain CRT-D devices (model DTBB2D4) 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 implantable cardioverter defibrillators (CRT-Ds) that may not deliver proper energy during high voltage therapy. This could lead to ineffective heart rhythm treatment for patients with heart failure.
The device uses a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy (0-12J). This could result in ineffective heart rhythm treatment for patients with heart failure.
Patients with implantable cardioverter defibrillators (CRT-Ds) using the recalled model DTBB2D4 are most at risk. The recall affects specific serial numbers and GTINs listed in the notice.
Check if your device has the model number DTBB2D4 and the listed serial numbers or GTINs (00643169720299 or 00643169980112). The device is an implantable cardioverter defibrillator for heart failure treatment.
Identify your device model number and compare it to DTBB2D4.
Reach out to Medtronic for confirmation of your device's serial numbers and GTINs.
The recall indicates a rare potential for reduced or no energy output during high voltage therapy, which could affect heart rhythm treatment. However, the risk is low and not immediate.
Check if your device has the model number DTBB2D4 and the specific serial numbers or GTINs listed in the recall notice.
Contact Medtronic to confirm your device's serial numbers and GTINs. They will provide guidance on 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-1746-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1746-2023 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.
