Medtronic recalls specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model DDBC3D4 and certain serial numbers due to rare risk of reduced or no energy output during high voltage therapy, which could affect device function.
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) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model number DDBC3D4. The recall is due to a rare potential for reduced or no energy output during high voltage therapy, which could cause the device to fail when needed. This is a serious but uncommon issue.
The device uses a specific type of glassed feedthrough that can occasionally cause reduced or no energy output during high voltage therapy (typically 0-12J). This means the device might not deliver the necessary shock to treat life-threatening heart rhythms when needed, though this is a rare occurrence.
People with Medtronic ICDs or CRT-Ds that match the specific model number and serial numbers listed in the recall. Most users are not at risk as this is a rare issue affecting only a small number of devices.
Check if your device has the model number DDBC3D4 and the specific serial numbers listed in the recall (e.g., BWF206541H, BWF206448H, etc.). The recall includes devices with GTIN 00643169720381 and 00643169980235.
Look for the model number DDBC3D4 on your device's label or documentation.
Compare your device's serial number to the list of affected serial numbers provided in the recall.
This is a rare potential issue that could cause reduced or no energy output during high voltage therapy, but it does not cause immediate harm. Most devices function safely.
No action is needed if your device's model number and serial number do not match the recalled items.
Check your device's model number against DDBC3D4 and compare your serial number to the list of affected serial numbers provided 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-1710-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1710-2023 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.
