Medtronic recalls specific MRI-safe defibrillators due to rare risk of device malfunction. Owners should check serial numbers RTP601047S and RTP601055S for affected units.
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Medtronic is recalling a specific type of MRI-safe defibrillator that could rarely malfunction. This might cause the device to stop working, which could be serious for people with heart conditions.
The device has a rare failure risk that could cause it to stop working. This might happen under unusual circumstances, but it's not a common issue.
People with implanted defibrillators who own the specific model with serial numbers RTP601047S or RTP601055S are affected. Those with heart conditions requiring this device are most at risk.
Check if your defibrillator has the serial numbers RTP601047S or RTP601055S. This model is designed for MRI scans and has Bluetooth wireless telemetry.
Look for the serial numbers RTP601047S or RTP601055S on your device.
Yes, this device is MR Conditional, meaning it's designed to be safe during MRI scans.
Check your serial number against RTP601047S or RTP601055S to see if you're affected. If you are, contact Medtronic for guidance.
The recall states it could rarely malfunction, but serious injury is not expected under 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-0927-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0927-2021 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.
