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 of injury.
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 have a specific glassed feedthrough. This design flaw may cause reduced or no energy output during high voltage therapy, potentially affecting device function. The recall does not indicate an immediate risk of injury or harm to users.
The device uses a glassed feedthrough that may cause reduced or no energy output during high voltage therapy (typically 0-12J). This is a rare issue that could affect device function but does not pose an immediate risk of injury or harm.
Patients with Medtronic ICDs or CRT-Ds manufactured with the specific glassed feedthrough (model DVME3D4) are affected. This recall does not pose an immediate risk of injury or harm to users.
Check your device model number: DVME3D4. Look for the specific lot/serial numbers listed in the recall (e.g., CWR601226S, CWR601747S, etc.).
Verify your device model number is DVME3D4. Check the lot/serial numbers against the list provided in the recall.
Reach out to Medtronic directly for guidance on next steps if your device is affected.
No, this recall does not pose an immediate risk of injury or harm. The issue is rare and may affect device function but does not cause immediate injury.
Check your device model number (DVME3D4) and compare the lot/serial numbers with the list provided in the recall.
If your device is affected, contact Medtronic for guidance. The recall does not require immediate action beyond verification.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1817-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1817-2023 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.
