Medtronic recalls certain CRTD DTMB2D1 AMPLIA MRI OUS DF1 implantable defibrillators due to rare potential for reduced or no energy output during high voltage therapy, which may affect device function. This recall includes specific lot numbers and serial codes.
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 (CRTDs) with model number DTMB2D1 due to a rare risk of reduced or no energy output during high voltage therapy. This could potentially cause the device to fail to deliver necessary shocks in emergencies. Affected devices have specific serial numbers listed in the recall.
The device uses a glassed feedthrough that can occasionally cause reduced or no energy output during high voltage therapy (typically 0-12J). This means the device might not deliver necessary shocks in emergencies, though this is a rare occurrence.
People with Medtronic CRTD DTMB2D1 implantable defibrillators (model number DTMB2D1) who have the listed serial numbers. Most users are likely safe as the risk is rare and only affects specific devices.
Check if your device has the model number DTMB2D1 and the specific serial numbers listed in the recall (e.g., RPQ605053S, RPQ606292S, etc.). The recall includes a list of serial numbers and lot numbers.
Look for the serial number on your device's label, which should match one of the listed serial numbers in the recall (e.g., RPQ605053S, RPQ606292S, etc.).
If your device is affected, contact Medtronic directly to confirm your device's status and receive instructions for next steps.
This recall involves a rare risk of reduced or no energy output during high voltage therapy, which could affect device function. However, the risk is very low and only affects specific devices with the listed serial numbers.
Check your device's serial number against the list of affected serial numbers provided in the recall (e.g., RPQ605053S, RPQ606292S, etc.).
No action is needed if your device's serial number is not listed in the recall. The recall only applies to specific devices with the listed serial numbers.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1765-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1765-2023 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.
