Medtronic recalls specific implantable heart devices (ICDs) due to possible failure to prevent high and low voltage therapy. Affected models include Evera MRI XT DR ICD DF1 and others with listed product numbers and serials.
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Medtronic is recalling certain implantable heart devices (ICDs) that may not properly prevent high or low voltage therapy. This could lead to ineffective treatment of heart rhythm issues. Affected devices include specific Evera MRI models with listed product numbers and serials.
The devices may fail to prevent high and low voltage therapy, which could lead to ineffective treatment of dangerous heart rhythms. This risk is specific to the recalled models and does not affect all Medtronic ICDs.
People with the recalled Evera MRI ICD models who have the listed product numbers and serials are most at risk. These devices are implanted in the heart to treat life-threatening arrhythmias.
Check if your device is labeled as Evera MRI XT DR ICD DF1, DF4, VR ICD DF4, or S DR ICD DF1. Look for the product numbers (DDMB1D1, DDMB1D4, DVMB1D4, DDMC3D1) and serial numbers listed in the recall notice.
Look for the product number and serial number on your device's label to confirm if it is affected.
Reach out to Medtronic directly to confirm if your device is affected and get instructions for next steps.
The recall affects Evera MRI ICD models with product numbers DDMB1D1, DDMB1D4, DVMB1D4, DDMC3D1, and DDMC3D4, each with specific serial numbers listed in the notice.
No, the recall does not require immediate discontinuation. Affected users should check their device label and contact Medtronic for guidance.
Check your device's label for the product number and serial number, then compare with the list provided in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0585-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0585-2018 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.
