Medtronic recalls specific Claria MRI CRT-D models due to possible prevention of critical heart therapy. Affected devices may not treat life-threatening arrhythmias properly.
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 Claria MRI CRT-D defibrillators that could prevent critical heart therapy. This risk means the device might not treat dangerous heart rhythms as intended, potentially putting users at risk of serious health issues.
These devices automatically detect and treat dangerous heart rhythms. The recall indicates a risk that the device might prevent therapy for high and low voltage heart conditions, which could lead to untreated life-threatening arrhythmias.
People with implanted Claria MRI CRT-D defibrillators from the listed product numbers are affected. Those with heart conditions requiring these devices are most at risk.
Check your device's product number (DTMA1D1, DTMA1QQ, DTMA1D4, or DTMA1Q1) and serial number against the listed UDI and serial numbers in the recall notice. The devices are labeled as Claria MRI CRT-D.
Identify your device's product number and serial number to confirm if it's affected by the recall.
Reach out to Medtronic for guidance on next steps if your device is affected.
The affected models are Claria MRI CRT-D DF1 (Product No. DTMA1D1), Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ), Claria MRI CRT-D DF4 (Product No. DTMA1D4), and Claria MRI Quad CRT-D DF1 (Product No. DTMA1Q1).
Check your device's product number and serial number against the listed UDI and serial numbers in the recall notice. The devices are labeled as Claria MRI CRT-D.
Contact Medtronic for guidance on next steps if your device is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0586-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0586-2018 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.
