Medtronic recalls certain implantable cardioverter defibrillators (ICDs) due to rare risk of reduced or no energy output during high voltage therapy. Affected models include ICD-VR DVBB1D1 EVERA XT IS1/DF1 US with specific serial numbers.
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) that may have a rare issue causing reduced or no energy output during high voltage therapy. This could potentially affect the device's ability to treat heart conditions properly.
The device uses a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. This could lead to the device not functioning properly when needed to treat heart conditions.
People with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) using the recalled model numbers are affected. Those with these devices are most at risk.
Check for the model number DVBB1D1 on your ICD-VR EVERA XT IS1/DF1 US device. Look for serial numbers starting with BWI218210H through BWI218222H.
Identify your device model and serial number to confirm if it's affected by this recall.
The recall describes a rare potential for reduced or no energy output during high voltage therapy, but it does not indicate a risk of serious injury or death in normal use.
The recall does not specify a remedy, so you should check with Medtronic directly for guidance.
Affected devices have the model number DVBB1D1 and serial numbers starting with BWI218210H through BWI218222H.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1795-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1795-2023 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.