Medtronic recalls certain implantable cardioverter defibrillators (ICDs) due to rare risk of reduced energy output during high voltage therapy. Affected models include ICD CROME DR MRI IS1 DF1 with model number DDPC3D1.
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 implantable cardioverter defibrillators (ICDs) that may have reduced or no energy output during high voltage therapy. This rare issue could affect the device's ability to properly treat heart conditions.
The device uses a specific type of glassed feedthrough that may cause reduced or no energy output during high voltage therapy (typically 0-12J). This could potentially affect the device's ability to treat heart conditions.
People with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) that match the specific model numbers and serial numbers listed in the recall. Those with these devices are most at risk.
Check if your device is labeled as ICD CROME DR MRI IS1 DF1 with model number DDPC3D1. Look for the GTIN 00763000178413 or 00763000178420 and the listed serial numbers in the recall.
Verify your device model number and serial numbers against the list provided in the recall.
Reach out to Medtronic directly to confirm if your device is affected and get guidance on next steps.
This recall affects specific Medtronic ICDs and CRT-Ds with model number DDPC3D1 and the listed serial numbers. Check your device details to see if you are affected.
Compare your device's model number and serial numbers with the list of affected units provided in the recall notice.
Contact Medtronic directly to confirm if your device is affected and get guidance on next steps. The recall does not include a specific remedy.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1727-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1727-2023 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.
