Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. This rare issue could affect device function but does not pose an immediate risk to patients.
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) with a specific glassed feedthrough. This rare issue could cause reduced or no energy output during high voltage therapy, potentially affecting device function. However, the risk is low and does not involve immediate injury.
The device may experience reduced or no energy output during high voltage therapy (typically 0-12J) due to a specific glassed feedthrough. This is a rare issue that could affect device function but does not involve immediate injury or risk to patients.
Patients with Medtronic ICD-DR DDMD3D4 PRIMO MRI devices manufactured with a specific glassed feedthrough. The recall affects a limited number of units with unique serial numbers.
Check if your device has the model number DDMD3D4 and the specific serial numbers listed in the recall (e.g., CWN606940S, CWN606941S, etc.).
Verify your device model number is DDMD3D4 and check if your serial number matches the list provided in the recall.
If your device is affected, contact Medtronic directly for further instructions.
This recall involves a rare potential for reduced or no energy output during high voltage therapy, but it does not pose an immediate risk to patients.
Check if your device has the model number DDMD3D4 and if your serial number matches the list of affected units provided in the recall.
No action is required if your device is not affected by this recall.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1718-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1718-2023 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.
