Medtronic recalls CRT-D defibrillators that may prevent high and low voltage therapy, risking heart failure. Affected devices have specific product numbers and serials. Stop using immediately.
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 cardiac defibrillators that could prevent necessary heart therapy, potentially leading to serious health risks. This recall affects specific models with unique product and serial numbers.
The recalled devices may prevent high and low voltage therapy, which is critical for treating heart rhythm issues. This could lead to serious complications like heart failure if the device fails to function properly.
People with implanted Medtronic CRT-D defibrillators that match the listed product numbers and serials are affected. Those with heart conditions requiring these devices are most at risk.
Check for product numbers DTMC1D1 or DTMC1QQ with specific serial numbers listed in the recall notice. The devices are labeled as Compia MRI CRT-D.
Immediately stop using the recalled defibrillator as it may prevent critical heart therapy.
Product numbers DTMC1D1 (serial RPW200289H) and DTMC1QQ (serials RPL201034H and others) are affected.
Look for the product numbers DTMC1D1 or DTMC1QQ with the specific serial numbers listed in the recall notice.
The recall does not mention repairs; the remedy is to stop using the device immediately.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0583-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0583-2018 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.