Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with model number DVMD3D1 due to a 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 use a glassed feedthrough. This rare issue could cause the device to not deliver enough energy during high voltage therapy, potentially affecting heart rhythm management. If you have one of these devices, you should contact Medtronic for guidance.
The device uses a glassed feedthrough that can occasionally cause reduced or no energy output during high voltage therapy (typically 0-12J). This is a rare occurrence but could affect the device's ability to deliver necessary electrical shocks for heart rhythm management.
People with Medtronic ICD-VR DVMD3D1 PRIMO MRI devices (model number DVMD3D1) that were manufactured with a specific glassed feedthrough. This includes certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
Check your device's model number (DVMD3D1) and lot/serial numbers listed in the recall notice. The recall includes specific serial numbers starting with CWK60... (e.g., CWK604305S, CWK601554S, etc.) and was sold with GTIN 00763000001520.
Verify your device's model number is DVMD3D1 and check the serial number against the list of affected units provided in the recall notice.
Reach out to Medtronic directly for guidance on next steps, as they may provide instructions for device evaluation or replacement.
This is a rare potential issue that could cause reduced or no energy output during high voltage therapy, but it does not pose an immediate risk to most users. Medtronic has not reported serious injuries from this issue.
Check your device's model number (DVMD3D1) and serial number against the list of affected units provided in the recall notice, which includes specific serial numbers starting with CWK60...
Medtronic will contact you if your device is affected; they may provide instructions for evaluation or replacement, but the recall does not require immediate replacement.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1814-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1814-2023 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.
