Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model DVMB2D4 and specific serial numbers due to rare potential for reduced or no energy output during high voltage therapy, which could affect treatment effectiveness.
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 lead to ineffective treatment of heart conditions. The recall affects devices with model number DVMB2D4 and specific serial numbers listed in the notice.
The hazard involves a rare potential for reduced or no energy output during high voltage therapy (typically 0-12J) in the device's specific glassed feedthrough. This could lead to ineffective treatment of heart conditions if the device fails to deliver the required energy during critical therapy sessions.
People with Medtronic ICDs or CRT-Ds using the recalled model number DVMB2D4 are most at risk. The recall affects individuals who have these devices implanted and are using the specific serial numbers listed.
Check if your device has model number DVMB2D4 and serial numbers listed in the recall notice (e.g., PLZ611718S, PLZ613233S, etc.). The recall includes specific serial numbers and GTIN 00643169720565.
Identify your device's model number (DVMB2D4) and serial number from the list provided in the recall notice.
The recalled devices have model number DVMB2D4.
Check if your device has model number DVMB2D4 and a serial number listed in the recall notice (e.g., PLZ611718S, PLZ613233S, etc.).
The recall notice states that the remedy is null, meaning no specific action is required beyond checking if your device is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1811-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1811-2023 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.
