Medtronic's ICD-DR DDMD3D1 PRIMO MRI devices with specific serial numbers may have reduced or no energy output during high voltage therapy, potentially causing cardiac issues. Affected devices include those with serial numbers listed in the recall.
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 certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may have reduced or no energy output during high voltage therapy. This rare issue could lead to cardiac problems if the device fails to deliver necessary shocks.
The device may have a glassed feedthrough that causes reduced or no energy output during high voltage therapy (typically 0-12J). This could lead to the device failing to deliver necessary shocks during cardiac emergencies, potentially causing serious cardiac issues.
People with Medtronic ICD-DR DDMD3D1 PRIMO MRI devices manufactured with a specific glassed feedthrough. Most users are likely to have no risk, but those with the recalled model numbers should check their device.
Check if your device has the model number DDMD3D1 and the specific serial numbers listed in the recall (e.g., CWM603134S, CWM600439S, etc.). The recall covers devices with these serial numbers.
Look for the serial number on your device's label, which should match one of the listed serial numbers in the recall.
If your device is affected, contact Medtronic directly for further instructions or to confirm if your device needs replacement.
This recall addresses a rare potential for reduced or no energy output during high voltage therapy, which could lead to cardiac issues if the device fails to deliver necessary shocks. However, the risk is low and not all devices are affected.
Check your device's serial number against the list of affected serial numbers provided in the recall. Affected devices have specific serial numbers like CWM603134S, CWM600439S, etc.
The recall does not specify a replacement; it recommends checking with Medtronic for further instructions if your device is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1717-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1717-2023 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.
