Medtronic recalls certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no energy output during high voltage therapy. Affected models include CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1 with specific serial numbers.
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) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have a rare potential for reduced or no energy output during high voltage therapy. This could affect the device's ability to deliver life-saving shocks if needed. The recall includes specific model numbers and serial numbers.
The hazard involves 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 shocks to treat life-threatening heart rhythms during critical situations.
People with Medtronic implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) that match the specific model and serial numbers listed in the recall are affected. Those with these devices are most at risk.
Check if your device is a CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1 model. Look for the specific serial numbers listed in the recall (e.g., RPU202561H, RPU202848H, etc.) or the GTIN 00643169837683 and lot numbers provided.
Identify your device model by checking the label on the device or its packaging. The affected models are CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1.
Compare your device's serial numbers (e.g., RPU202561H, RPU202848H) with the list provided in the recall to determine if it is affected.
Your device is at risk if it is a CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1 model with one of the specific serial numbers listed in the recall (e.g., RPU202561H, RPU202848H).
Contact Medtronic directly to confirm if your device is affected and follow their instructions for next steps. The recall does not specify a remedy.
This is a rare potential for reduced or no energy output during high voltage therapy, which could affect the device's ability to deliver life-saving shocks. However, the risk is low and not expected to cause serious injury in normal use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1763-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1763-2023 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.
