Medtronic recalls certain implantable cardioverter defibrillators due to rare risk of reduced or no energy output during high voltage therapy. Affected models include ICD-VR VISIA AF XT OUS DF4 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 may have reduced or no energy output during high voltage therapy. This could potentially affect the device's ability to treat heart conditions if the problem occurs during critical medical events.
The device uses a glassed feedthrough that may cause reduced or no energy output during high voltage therapy. This could affect the device's ability to deliver life-saving shocks if needed during critical heart events.
People with implantable cardioverter defibrillators (ICDs) who own the specific model numbers and serial numbers listed in the recall. Those with heart conditions requiring ICDs are most at risk.
Check for the model number DDVAB2D4 on your ICD-VR VISIA AF XT OUS DF4 device. Look for serial numbers starting with BWT600023S through BWT600040S as listed in the recall.
Verify your device model number is DDVAB2D4 and your serial number starts with BWT600023S through BWT600040S.
The recall does not require immediate stop use; the hazard is rare and the device may still function safely.
Contact Medtronic directly to confirm your device's status and follow their instructions for potential repair or replacement.
This hazard is rare and only affects specific models; most users will not experience issues.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1792-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1792-2023 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.
