Medtronic recalls certain implantable cardioverter defibrillators (ICDs) manufactured with a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. Affected models include ICD COBALT VR MRI IS1 DF1 with model number DVPB3D1.
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) that may have reduced or no energy output during high voltage therapy. This rare issue could potentially lead to the device not functioning properly when needed. Affected devices have specific model numbers and serial numbers listed in the recall.
The recall addresses a rare potential for reduced or no energy output during high voltage therapy (typically 0-12J) in devices with a specific glassed feedthrough. This could mean the device might not deliver the necessary electrical shocks during critical medical situations.
People with Medtronic implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) that have the specific model number DVPB3D1 and the listed serial numbers are affected. Those with these devices are most at risk.
Check if your device has the model number DVPB3D1 and the listed serial numbers (RSE600116S through RSE603171S). The devices are identified by the GTIN 00763000178499 and the specific serial numbers provided in the recall.
Verify your device's model number is DVPB3D1 and check the serial number against the list provided in the recall.
If your device is affected, contact Medtronic directly for further instructions on how to proceed with the recall.
The affected devices have the model number DVPB3D1.
Check your device's model number and serial number against the list of affected serial numbers provided in the recall (RSE600116S through RSE603171S).
The recall does not specify a replacement; it advises checking with Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1820-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1820-2023 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.
