Medtronic recalls certain implantable cardioverter defibrillators (ICDs) due to rare risk of reduced or no energy output during high voltage therapy. Affected models include ICD-VR VISIA AF S US/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 a rare issue causing reduced or no energy output during high voltage therapy. This could potentially lead to inadequate treatment of heart conditions if the device fails to deliver necessary shocks.
The device uses a specific type of glassed feedthrough that can occasionally fail to deliver sufficient energy during high voltage therapy. This may result in the device not properly treating heart arrhythmias when needed, though this is a rare occurrence.
People with implantable cardioverter defibrillators (ICDs) who own the specific model numbers and serial numbers listed in the recall. Those with heart conditions requiring an ICD are most at risk.
Check your ICD model number and serial numbers against the list provided in the recall. The affected devices are labeled as ICD-VR VISIA AF S US/OUS DF4 with specific serial numbers starting with BWV600051S through BWV600318S.
Review your device's model number and serial numbers to see if they match the listed affected units.
The recall describes a rare potential for reduced or no energy output during high voltage therapy, but it does not indicate a risk of serious injury or death in normal use.
Compare your device's model number and serial numbers with the list of affected units provided in the recall.
The recall does not specify a remedy, so you should contact Medtronic directly 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-1794-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1794-2023 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.
