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 hazard requires replacement.
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 use a specific glassed feedthrough. This design flaw could cause the device to fail to deliver proper energy during high voltage therapy, potentially leading to ineffective treatment. The recall is for specific model numbers and serial numbers.
The device uses a glassed feedthrough that can sometimes fail to deliver sufficient energy during high voltage therapy (typically 0-12J). This may result in reduced or no energy output, which could affect the device's ability to treat heart conditions effectively.
Patients with Medtronic ICDs or CRT-Ds manufactured with the specific glassed feedthrough are affected. Most users are not at immediate risk as this is a rare occurrence.
Check your device's model number (DVME3D1) and serial number (listed in the recall). The recall includes specific serial numbers starting with CWP60... and GTIN 00763000001605.
Verify your device's model number (DVME3D1) and serial number (CWP60... format) to see if it's affected.
Reach out to Medtronic directly to confirm if your device is in the recall and to arrange for replacement.
This is a rare hazard that could cause reduced or no energy output during high voltage therapy, but it does not pose an immediate risk to most users.
Check your device's model number (DVME3D1) and serial number (CWP60... format) against the list of affected serial numbers provided in the recall.
Yes, if your device is affected, Medtronic will provide a replacement device with the corrected design.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1816-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1816-2023 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.
