Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model number DVMD3D4. A rare potential for reduced or no energy output during high voltage therapy may cause ineffective treatment. This recall includes specific lot and serial numbers listed in the notice.
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) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model number DVMD3D4. These devices have a rare potential for reduced or no energy output during high voltage therapy, which could lead to ineffective treatment. The recall affects specific lot and serial numbers.
The hazard involves a rare potential for reduced or no energy output during high voltage therapy (typically 0-12J) in these devices. This could result in ineffective treatment if the device fails to deliver the necessary energy during critical medical events.
People with Medtronic ICDs or CRT-Ds using the specific model number DVMD3D4 are most at risk. The recall affects a limited number of devices with specific lot and serial numbers.
Check your device's model number and lot/serial numbers. The recalled devices have model number DVMD3D4 and specific lot and serial numbers listed in the recall notice.
Identify your device's model number, which should be DVMD3D4 for the recalled devices.
Compare your device's lot and serial numbers with the list provided in the recall notice to determine if it is affected.
This recall involves a rare potential for reduced or no energy output during high voltage therapy, which could lead to ineffective treatment. However, the risk is low and not expected to cause serious injury in normal use.
Check your device's model number and lot/serial numbers against the list provided in the recall notice. The affected devices have model number DVMD3D4 and specific lot and serial numbers listed in the notice.
If your device's model number and lot/serial numbers are not on the list, no action is required.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1815-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1815-2023 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.