Medtronic's ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1 models have a rare risk of reduced or no energy output during high voltage therapy. Affected units include specific serial numbers listed in the recall.
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's certain implantable cardioverter defibrillators (ICDs) have a rare risk of reduced or no energy output during high voltage therapy. This could potentially cause the device to fail to treat life-threatening heart rhythms. Affected models include specific serial numbers listed in the recall.
The device uses a specific glassed feedthrough that can occasionally cause reduced or no energy output during high voltage therapy (typically 0-12J). This is a rare issue that may lead to the device failing to treat life-threatening heart rhythms.
People with Medtronic ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1 implantable cardioverter defibrillators. Most users are patients with heart conditions who have received these devices.
Check your device's model number and serial number. Affected units are labeled as ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1 with specific serial numbers listed in the recall.
Identify your device model and serial number to see if it matches the affected units listed in the recall.
If your device is affected, contact Medtronic directly for further instructions.
This is a rare issue that could potentially cause the device to fail to treat life-threatening heart rhythms, but it does not pose an immediate risk to most users.
Check your device's model number and serial number against the list of affected units provided in the recall.
Contact Medtronic directly for further instructions on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1807-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1807-2023 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.
