Medtronic recalls certain ICD-DR DDBB1D4 EVERA XT IS1/DF4 implantable defibrillators due to rare potential for reduced or no energy output during high voltage therapy. This may 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 specific models of implantable cardioverter defibrillators (ICDs) that may have a rare issue with energy output during high voltage therapy. This could potentially cause the device to not function properly during emergencies, but the risk is very low and not immediately life-threatening.
The device may have a rare issue with a glassed feedthrough component that can cause reduced or no energy output during high voltage therapy (typically 0-12J). This could potentially lead to the device not functioning properly during emergencies, but the risk is very low and not immediately life-threatening.
People with Medtronic ICD-DR DDBB1D4 EVERA XT IS1/DF4 implantable defibrillators manufactured with a specific glassed feedthrough are affected. Those with the recalled model numbers and serial numbers listed in the recall are most at risk.
Check if your device is labeled as ICD-DR DDBB1D4 EVERA XT IS1/DF4 US with model number DDBB1D4. Look for the specific serial numbers listed in the recall (e.g., BWB231977H, BWB232204H) or GTIN 00643169720374.
Verify your device model and serial number against the list of affected units provided in the recall notice.
Reach out to Medtronic directly to confirm if your device is affected and to get instructions on next steps.
The recall describes a rare potential for reduced or no energy output during high voltage therapy, but it is not immediately dangerous. The risk is very low and not life-threatening.
Check if your device is labeled as ICD-DR DDBB1D4 EVERA XT IS1/DF4 US with model number DDBB1D4 and has one of the specific serial numbers listed in the recall.
Contact Medtronic directly to confirm if your device is affected and to get instructions on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1705-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1705-2023 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.
