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 VISIA MRI AF XT OUS DF4 with model number DVFB2D4.
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 which may cause reduced or no energy output during high voltage therapy. This could potentially lead to the device not functioning properly when needed. The recall affects specific models and serial numbers.
The device has a glassed feedthrough that may cause reduced or no energy output during high voltage therapy (typically 0-12J). This could mean the device doesn't deliver the necessary electrical shocks to treat life-threatening heart rhythms when needed.
People with Medtronic ICD-VR VISIA MRI AF XT OUS DF4 devices with model number DVFB2D4 are affected. The risk is low as the hazard is rare and only occurs under specific high voltage therapy conditions.
Check if your device is labeled as ICD-VR VISIA MRI AF XT OUS DF4 with model number DVFB2D4. The recall includes specific serial numbers and lot numbers listed in the official notice.
Identify your device model and serial number to see if it matches the recalled units.
Reach out to Medtronic directly for assistance with the recall and to determine if your device is affected.
Medtronic is recalling certain ICDs with a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy.
Check your device model and serial number against the list of affected units provided in the recall notice.
The recall does not require replacement; affected devices should be checked with Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1806-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1806-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
