Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model number DDMB1D1 due to a 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 proper energy during high voltage therapy. This could lead to the device failing to treat heart conditions effectively. The recall affects devices with model number DDMB1D1 and specific serial numbers.
The device uses a specific type of glassed feedthrough that can occasionally fail to deliver sufficient energy during high voltage therapy. This is a rare occurrence but could result in the device not functioning properly when needed to treat heart rhythm issues.
People with Medtronic ICD-DR DDMB1D1 Evera MRI XT devices (model number DDMB1D1) that were implanted between 2010 and 2023 are affected. Most users are patients with heart conditions who have received these devices.
Check your device's model number (DDMB1D1) and serial number (listed in the recall as CWA218162H through CWA232439H). The devices were sold between 2010 and 2023.
Verify your device's model number is DDMB1D1 and serial number starts with CWA218162H through CWA232439H.
Reach out to Medtronic directly for guidance on next steps, as they may provide a replacement or repair.
Medtronic may offer a replacement or repair, but you should contact them directly to determine the best course of action for your specific device.
This is a rare occurrence, as the hazard is described as a potential risk during high voltage therapy, not a widespread failure.
Yes, the device is safe to keep using under normal conditions, but you should monitor for any signs of malfunction and contact Medtronic if you have concerns.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1711-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1711-2023 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.
