Medtronic recalls certain AMPLIA MRI defibrillators (model DTMB1D4) due to rare risk of reduced or no energy output during high voltage therapy. Affected units have specific serial numbers and GTIN. No immediate action needed but monitor for potential issues.
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 AMPLIA MRI defibrillators (model DTMB1D4) that may have a rare risk of reduced or no energy output during high voltage therapy. This could potentially affect the device's ability to deliver necessary shocks. The recall includes specific serial numbers and GTIN.
The device uses a specific type of glassed feedthrough that can occasionally cause reduced or no energy output during high voltage therapy (typically 0-12J). This may prevent the device from delivering necessary shocks in emergencies, but the risk is rare and not expected to cause serious injury.
Patients with Medtronic AMPLIA MRI defibrillators (model DTMB1D4) who have the listed serial numbers or GTIN are affected. The risk is rare and not expected to cause serious injury in normal use.
Check your device's serial numbers against the list provided in the recall (e.g., RPJ204877H, RPJ205009H, etc.) or GTIN 00643169720718. The model number is DTMB1D4 for AMPLIA MRI defibrillators.
Compare your device's serial number to the list of affected serial numbers provided in the recall (e.g., RPJ204877H, RPJ205009H, etc.).
If your device is affected, monitor for any unusual symptoms or failure to deliver shocks during high voltage therapy.
The recall indicates a rare risk of reduced or no energy output during high voltage therapy, but it is not expected to cause serious injury in normal use.
Check your device's serial number against the list of affected serial numbers (e.g., RPJ204877H, RPJ205009H, etc.) or GTIN 00643169720718.
No immediate action is required, but you should monitor your device for any unusual symptoms and check if your serial number is on the list.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1762-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1762-2023 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.
