Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model DVPB3D4 and specific serial numbers due to rare potential for reduced or no energy output during high voltage therapy, which could affect device function.
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 specific models of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have a rare risk of not delivering enough energy during high voltage therapy. This could cause the device to fail when needed. The recall affects devices with model number DVPB3D4 and specific serial numbers listed in the record.
The device uses a glassed feedthrough that can sometimes cause reduced or no energy output during high voltage therapy (typically 0-12J). This means the device might not function properly when it needs to deliver a shock to treat a life-threatening heart rhythm.
People with Medtronic ICDs or CRT-Ds manufactured with the specific glassed feedthrough mentioned in the recall are most at risk. The recall applies to devices with model number DVPB3D4 and the listed serial numbers.
Check if your device has model number DVPB3D4 and one of the serial numbers listed in the recall record. The recall includes specific serial numbers starting with RSF600012S through RSF608092S.
Identify your device's model number, which should be DVPB3D4 for the recalled devices.
Check if your device's serial number matches any of the listed serial numbers in the recall record.
No, this recall specifically applies to ICDs and CRT-Ds with model number DVPB3D4 and the listed serial numbers.
Check your device's model number (should be DVPB3D4) and serial number against the list of affected serial numbers provided in the recall record.
No action is needed if your device's model number and serial number do not match the recalled items.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1821-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1821-2023 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.