Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model DVFB1D4 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 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model number DVFB1D4. This recall is due to a rare potential for reduced or no energy output during high-voltage therapy, which could affect the device's ability to properly treat heart conditions.
The device uses a specific glassed feedthrough that could cause reduced or no energy output during high-voltage therapy (typically 0-12J). This means the device might not deliver the necessary electrical shocks to treat heart arrhythmias in some situations.
People with Medtronic ICDs or CRT-Ds with model number DVFB1D4 are affected. Most users are likely to have no issues, as this is a rare potential issue.
Check your device's model number, which is DVFB1D4. This recall includes specific lot and serial numbers listed in the official record. The product is an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
Look for the model number DVFB1D4 on your device's label or documentation.
If your device is affected, contact Medtronic directly for further instructions.
This recall addresses a rare potential for reduced or no energy output during high-voltage therapy, which could affect device function. However, it is not expected to cause serious injury in normal use.
Check your device's model number. If it is DVFB1D4, and your lot or serial number matches the list provided in the recall, your device is affected.
No action is needed if your device model is not DVFB1D4 or your lot/serial number is not in the list provided in the recall.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1804-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1804-2023 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.
