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 is not immediately dangerous.
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 rare issue could cause reduced or no energy output during high voltage therapy, potentially affecting device function. The recall does not indicate immediate danger but requires monitoring.
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 the device's ability to deliver necessary shocks, but it does not cause immediate harm.
Patients with Medtronic ICDs or CRT-Ds manufactured with the specific glassed feedthrough (model DDME3D1) are affected. This includes individuals who have received the device as part of their medical treatment.
Check if your device has the model number DDME3D1 and the specific glassed feedthrough. The recall includes devices with lot/serial numbers listed in the record (e.g., CWS603181S, CWS601328S, etc.).
Identify your device model number (DDME3D1) and check if it matches the list of affected serial numbers provided in the recall.
If your device is affected, contact Medtronic directly to discuss potential remedies or monitoring options.
The recall indicates a rare potential for reduced or no energy output during high voltage therapy, but it does not cause immediate harm. The risk is low and not immediately dangerous.
Check if your device has the model number DDME3D1 and a lot/serial number listed in the recall (e.g., CWS603181S, CWS601328S, etc.).
Contact Medtronic directly to discuss potential remedies or monitoring options.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1719-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1719-2023 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.
