Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model DVBC3D4 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 proper energy during high-voltage therapy. This could potentially lead to device malfunction if the condition occurs.
The hazard involves a rare potential for reduced or no energy output during high voltage therapy (typically 0-12J) in the device's glassed feedthrough. This could cause the device to fail to deliver necessary shocks in emergencies.
People with Medtronic ICDs or CRT-Ds using the specific model DVBC3D4 are affected. Those with the recalled devices are most at risk.
Check your device's model number and serial numbers. The recalled models are ICD-VR DVBC3D4 EVERA S DF4 GLOB with GTIN 00643169720442 or 00643169980273 and specific serial numbers listed in the recall.
Identify your device model and serial numbers to see if they match the recalled items listed in the recall notice.
If your device is affected, contact Medtronic directly for further instructions on device replacement or repair.
The recalled devices have model number DVBC3D4, specifically the ICD-VR EVERA S DF4 GLOB series.
Check your device's model number and serial numbers against the list of affected units provided in the recall notice.
No action is required if your device model and serial numbers 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-1800-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1800-2023 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.
