Medtronic recalls specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a glassed feedthrough that may cause reduced or no energy output during high voltage therapy. Affected models include ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL with serial numbers listed.
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 certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may have a glassed feedthrough causing reduced or no energy output during high voltage therapy. This rare issue could affect device function but does not pose an immediate risk to users.
The device uses a glassed feedthrough that may cause reduced or no energy output during high voltage therapy (typically 0-12J). This could lead to the device failing to deliver necessary shocks during critical heart rhythm events, but the risk is rare and not immediate.
People with Medtronic ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough. Most users are not at risk as this is a rare issue.
Check if your device has the model number DDBB2D1 and serial numbers listed in the recall (e.g., BWE613480S, BWE613110S, etc.). The device is an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
Identify if your device is an ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL model with the listed serial numbers.
This recall addresses a rare potential for reduced or no energy output during high voltage therapy, but it does not pose an immediate risk to users. The risk is low and not common.
If your device matches the model and serial numbers listed, you should check with Medtronic for further instructions. Otherwise, no action is needed.
Check if your device has the model number DDBB2D1 and serial numbers from the list provided in the recall (e.g., BWE613480S, BWE613110S, etc.).
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1707-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1707-2023 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.
