Medtronic recalls specific implantable defibrillators due to rare risk of device malfunction. Affected units have serial numbers RSN600251S and RSN600656S. No immediate action required per recall.
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 implantable defibrillator that has a rare risk of malfunction. This could potentially cause the device to stop working, but it's not expected to happen often.
The device has a rare failure mechanism that could cause it to stop working. This might happen under uncommon conditions but is not expected to occur frequently.
People with the specific Medtronic Cobalt DR MRI SureScan DDPB3D1 defibrillator model (serial numbers RSN600251S and RSN600656S) are affected. Those with this device are most at risk.
Check if your defibrillator has the model name 'Medtronic Cobalt DR MRI SureScan DDPB3D1' and serial numbers RSN600251S or RSN600656S. This model includes Bluetooth wireless telemetry.
Look for the serial numbers RSN600251S or RSN600656S on your device.
No immediate action is required per the recall notice.
The device has a rare risk of malfunction that could cause it to stop working, but this is not expected to happen frequently.
Check if your device has the model name 'Medtronic Cobalt DR MRI SureScan DDPB3D1' and serial numbers RSN600251S or RSN600656S.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0928-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0928-2021 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.