Medtronic's ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1 models have a rare risk of reduced or no energy output during high voltage therapy. Affected devices include specific serial numbers listed in the recall. Contact Medtronic for replacement.
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 ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1 implantable cardioverter defibrillators have a rare risk of reduced or no energy output during high voltage therapy. This could potentially cause the device to fail when needed in emergencies. The recall includes specific serial numbers.
The device uses a glassed feedthrough that can cause reduced or no energy output during high voltage therapy (typically 0-12J). This is a rare issue that could potentially cause the device to fail when needed in emergencies.
Patients with Medtronic ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1 devices. Those with the specific serial numbers listed in the recall are most at risk.
Check your device's model number (DVFB2D1) and serial number (CWH604762S, CWH602704S, etc.) against the list provided in the recall. The recall includes specific serial numbers.
Identify your device's model number (DVFB2D1) and serial number to see if it's listed in the recall.
Reach out to Medtronic for instructions on replacement or repair if your device is affected.
The devices have a rare risk of reduced or no energy output during high voltage therapy (0-12J), which could potentially cause the device to fail when needed in emergencies.
Check your device's model number (DVFB2D1) and serial number against the list of affected serial numbers provided in the recall.
No, the risk is rare and the device can still function safely. Contact Medtronic for replacement or repair instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1805-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1805-2023 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.
