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 DVBB1D4 EVERA XT DF4 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 reduced or no energy output during high voltage therapy. This could potentially lead to inadequate treatment of heart conditions if the device fails to deliver necessary shocks.
The device uses a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. This could result in the device failing to deliver necessary shocks when needed for heart conditions.
People with implantable cardioverter defibrillators (ICDs) that match the specific model and serial numbers listed in the recall. Those with heart conditions requiring regular defibrillator therapy are most at risk.
Check if your ICD model is ICD-VR DVBB1D4 EVERA XT DF4 US with serial numbers BWH224619H, BWH224621H, BWH224620H, or BWH224623H. The device may have a GTIN number 00643169720435.
Verify your device model matches ICD-VR DVBB1D4 EVERA XT DF4 US with the listed serial numbers.
The recall does not require immediate stop use; affected devices may continue to function but should be checked for the specific issue.
Contact Medtronic directly to confirm if your device is affected and follow their instructions for evaluation.
This is a rare potential issue that may not affect all users, but it could lead to inadequate treatment of heart conditions if the device fails to deliver necessary shocks.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1796-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1796-2023 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.
