Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model DDMB1D4 due to rare potential for reduced or no energy output during high voltage therapy, which could affect device function.
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 (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have a rare risk of not delivering enough energy during high voltage therapy. This could cause the device to fail when needed, potentially leading to serious health issues for patients with heart conditions.
The device uses a glassed feedthrough that can sometimes cause reduced or no energy output during high voltage therapy (typically 0-12J). This means the device might not function properly when it needs to deliver a shock to treat a life-threatening heart rhythm.
Patients with Medtronic ICDs or CRT-Ds with model number DDMB1D4 are affected. Those with the specific lot and serial numbers listed in the recall are most at risk.
Check your device's model number, which is DDMB1D4. Look for the lot and serial numbers listed in the recall (e.g., PFZ236436H, PFZ242339H, etc.).
Identify your device model by checking the label on the device itself or the packaging. The affected models are DDMB1D4.
Compare your device's lot and serial numbers with the list provided in the recall to determine if it is affected.
This recall addresses a rare potential for reduced or no energy output during high voltage therapy, which could affect device function. However, it is not expected to cause serious injury in normal use.
Check your device's model number (DDMB1D4) and compare your lot and serial numbers with the list provided in the recall.
If your device is affected, contact Medtronic for further instructions. They may provide a 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-1712-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1712-2023 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.
