Medtronic's ICD-DR DDMB2D1 EVERA MRI XT OUS DF1 models may have reduced or no energy output during high voltage therapy, potentially causing treatment failure. Affected units include specific serial numbers listed in the recall.
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's ICD-DR DDMB2D1 EVERA MRI XT OUS DF1 implantable cardioverter defibrillators may not deliver proper energy during high voltage therapy, risking treatment failure. This rare issue affects specific models with certain serial numbers.
The device uses a glassed feedthrough that can cause reduced or no energy output during high voltage therapy (typically 0-12J). This may lead to treatment failure in some cases, but the risk is rare and not immediate.
Patients with Medtronic ICD-DR DDMB2D1 EVERA MRI XT OUS DF1 implantable cardioverter defibrillators manufactured with a specific glassed feedthrough are affected. The risk is rare and not immediate.
Check if your device has the model number DDMB2D1 and the serial numbers listed in the recall (e.g., CWB609778S, CWB609784S).
Identify your device model and serial number to confirm if it is affected.
Reach out to Medtronic for specific guidance on next steps if your device is affected.
Check if your device has the model number DDMB2D1 and a serial number listed in the recall (e.g., CWB609778S, CWB609784S).
No action is needed if your device is not listed in the recall.
This is a rare risk that may cause treatment failure in some cases, but it is not immediate and does not pose a high risk of injury.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1713-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1713-2023 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.
