Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. Affected models include DTMC2D4 with specific serial numbers.
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 glassed feedthrough. This could lead to reduced or no energy output during high voltage therapy, potentially affecting device function. The recall involves specific model numbers and serial numbers.
The device uses a glassed feedthrough that can sometimes fail to deliver the full energy needed during high voltage therapy. This is a rare occurrence and typically does not cause serious injury, but may lead to reduced effectiveness of the device in certain situations.
People with Medtronic ICDs or CRT-Ds that have the DTMC2D4 model number and specific serial numbers listed in the recall. Most users are likely to be at low risk as the hazard is rare and the device is designed to function normally.
Check if your device has the model number DTMC2D4 and the specific serial numbers listed in the recall (e.g., RPH603922S, RPH608147S, etc.).
Look for the model number DTMC2D4 on your device's label.
Compare your device's serial number with the list of affected serial numbers provided in the recall.
The devices may have reduced or no energy output during high voltage therapy due to a glassed feedthrough, which is a rare occurrence.
If your device's model and serial number are not listed, you do not need to take any action.
This is a rare occurrence and does not typically cause serious injury.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1772-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1772-2023 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.
