Medtronic's ICD-VR VISIA MRI AF S US/OUS DF4 models (DVFC3D4) with specific lot numbers may have reduced energy output during high voltage therapy. This rare issue could affect defibrillator function. Contact Medtronic for details.
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 cause the device to fail when needed. Affected models include specific lot numbers listed in the recall.
The device uses a specific glassed feedthrough that can sometimes fail during high voltage therapy (0-12J). This may result in reduced or no energy output when the device needs to shock the heart. The issue is rare and not expected to cause serious injury in typical use.
People with Medtronic ICD-VR VISIA MRI AF S US/OUS DF4 models (DVFC3D4) who have the listed lot numbers. The risk is rare and not likely to cause serious injury in normal use.
Check your device's model number (DVFC3D4) and lot numbers (PMX613090S, PMX610759S, etc.) listed in the recall. The device is an implantable cardioverter defibrillator (ICD).
Reach out to Medtronic directly for specific guidance on your device and whether it is affected.
This is a rare potential issue that could affect device function during high voltage therapy, but it is not expected to cause serious injury in normal use.
Check your device's model number (DVFC3D4) and lot number against the list of affected serial numbers provided in the recall.
The recall does not specify a replacement; contact Medtronic for specific instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1808-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1808-2023 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.
