Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model number DDMC3D1 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 lead to the device failing to treat heart conditions properly. The recall affects devices with model number DDMC3D1 and specific serial numbers.
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 needed to treat heart conditions, but it's a rare occurrence.
People with Medtronic ICDs or CRT-Ds with model number DDMC3D1 and specific serial numbers listed in the recall are affected. Most users are not at risk as this is a rare issue.
Check if your device has model number DDMC3D1 and serial numbers listed in the recall (e.g., CWC602314S, CWC602130S, etc.). The recall includes specific serial numbers and lot numbers.
Look for the model number DDMC3D1 on your device's label or documentation.
Compare your device's serial number to the list of affected serial numbers provided in the recall.
This is a rare issue that could cause reduced or no energy output during high voltage therapy, but it's not a common problem. Most devices function normally.
No action is needed if your device's serial number is not listed in the recall.
Check the model number on your device and compare the serial number to the list of affected serial numbers provided in the recall.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1715-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1715-2023 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.
