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 XT OUS IS1/DF1 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 cause the device to fail to deliver necessary shocks during emergencies. The recall affects specific model numbers and serial numbers listed in the notice.
The recalled ICDs use a specific type of glassed feedthrough that may cause reduced or no energy output during high voltage therapy. This could mean the device fails to deliver necessary shocks during critical heart rhythm emergencies.
People with implantable cardioverter defibrillators (ICDs) that match the specific model numbers and serial numbers listed in the recall notice are affected. Those with the recalled devices are most at risk.
Check if your device is labeled as ICD-VR VISIA AF XT OUS IS1/DF1 with model number DVAB2D1. Look for the serial numbers listed in the recall notice, which start with BWR600821S through BWR601104S.
Look for the model number DVAB2D1 and serial numbers starting with BWR600821S through BWR601104S on your device.
Medtronic identified a rare potential for reduced or no energy output during high voltage therapy in these specific ICD models, which could affect emergency shock delivery.
No action is needed if your device does not match the specific model numbers and serial numbers listed in the recall notice.
Check your device label for the model number DVAB2D1 and serial numbers starting with BWR600821S through BWR601104S as listed in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1791-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1791-2023 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.
