Medtronic recalls certain implantable cardioverter defibrillators (ICDs) manufactured with a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. Affected models include ICD-VR DVMB2D1 EVERA MRI XT OUS DF1 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 specific glassed feedthrough. These devices may not deliver proper energy during high voltage therapy, which could affect heart rhythm management. This is a rare but potential issue that requires attention.
The device uses a glassed feedthrough that can sometimes fail to deliver adequate energy during high voltage therapy (0-12J). This rare issue may lead to reduced or no energy output, potentially affecting the device's ability to manage heart rhythm.
People with Medtronic ICD-VR DVMB2D1 EVERA MRI XT OUS DF1 implantable cardioverter defibrillators. Those with the specific serial numbers listed in the recall are most at risk.
Check if your device is an ICD-VR DVMB2D1 EVERA MRI XT OUS DF1 model with the specific serial numbers listed in the recall. The GTIN is 00643169837768 or 00763000206178.
Identify your device model and serial number to see if it matches the recalled items.
Reach out to Medtronic for guidance on next steps if your device is affected.
This is a rare potential issue that may cause reduced or no energy output during high voltage therapy. It is not expected to cause serious injury but requires monitoring.
Check if your device is an ICD-VR DVMB2D1 EVERA MRI XT OUS DF1 model with the specific serial numbers listed in the recall.
Contact Medtronic for guidance on next steps. They will provide instructions for monitoring or potential replacement.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1810-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1810-2023 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.
