Medtronic recalls specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model DDBB1D1 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) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model number DDBB1D1. The recall is due to a rare potential for reduced or no energy output during high voltage therapy, which could impact device function but is not immediately dangerous.
The device uses a specific glassed feedthrough that can occasionally fail during high voltage therapy (typically 0-12J), leading to reduced or no energy output. This may cause the device to not function properly during critical heart rhythm events, but the risk is rare and not immediately life-threatening.
People with Medtronic ICD-DR DDBB1D1 EVERA XT IS1/DF1 implants, particularly those with heart conditions requiring these devices. Most users are not at risk as the issue is rare and not immediately dangerous.
Check if your device has model number DDBB1D1 and lot/serial numbers listed in the recall (e.g., BWC242988H, BWC241999H, etc.). The device is an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
Verify your device model number is DDBB1D1 and lot/serial numbers match the list provided in the recall.
Reach out to Medtronic directly for guidance on next steps if your device is affected.
The recall is for a rare potential issue with reduced or no energy output during high voltage therapy, but it is not immediately dangerous. The risk is low and not life-threatening.
Check if your device has model number DDBB1D1 and lot/serial numbers listed in the recall (e.g., BWC242988H, BWC241999H, etc.).
The recall does not require device replacement; contact Medtronic for guidance on next steps if affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1704-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1704-2023 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.
