Medtronic Evera XT ICDs with model number DDBB2D4 and specific serial numbers may have reduced or no energy output during high voltage therapy. This rare issue could affect device function but does not cause injury. Affected devices must be checked by a doctor.
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 Evera XT ICDs with model number DDBB2D4 and specific serial numbers may have reduced or no energy output during high voltage therapy. This rare issue could affect device function but does not cause injury. Affected devices must be checked by a doctor.
The device uses a specific type of glassed feedthrough that can cause reduced or no energy output during high voltage therapy (typically 0-12J). This is a rare issue that may affect device function but does not cause injury.
People with Medtronic Evera XT ICDs (implantable cardioverter defibrillators) that have the model number DDBB2D4 and specific serial numbers listed in the recall are affected. Those with the device are most at risk.
Check if your device has the model number DDBB2D4 and one of the listed serial numbers or GTINs. The product is an implantable cardioverter defibrillator (ICD) used for heart conditions.
Your doctor will check if your device is affected and provide instructions on next steps.
No, this issue is rare and does not cause injury. It may affect device function but does not pose a risk of serious injury.
Contact your doctor to check if your device is affected and follow their instructions.
Check if your device has the model number DDBB2D4 and one of the specific serial numbers listed in the recall.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1708-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1708-2023 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.