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 DVBB2D4 EVERA XT DF4 INTL 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 have a rare potential for reduced or no energy output during high voltage therapy. This could affect the device's ability to treat heart conditions effectively.
The device uses a specific type of glassed feedthrough that can occasionally fail to deliver the required energy during high voltage therapy (0-12J). This rare issue might prevent the device from properly treating heart conditions.
People with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) that match the specific model and serial numbers listed in the recall. Those with these devices are most at risk.
Check if your device is labeled as ICD-VR DVBB2D4 EVERA XT DF4 INTL with the specific model number DVBB2D4. Look for the GTIN numbers and serial numbers listed in the recall notice.
Review your device's model number and serial numbers to see if they match the recalled items listed in the notice.
The recall notice does not specify if devices not listed are affected. Check the full list of serial numbers provided in the recall.
The recall states it is a rare potential issue, but the exact frequency is not specified in the notice.
The recall notice does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1798-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1798-2023 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.
