Medtronic recalls specific Cobalt CRT-D defibrillators due to a potential manufacturing error in cathode components, though all devices passed functional tests.
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Medtronic is recalling certain Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) devices because of a possible manufacturing error in the cathode component. This could pose a risk, but all recalled devices passed final functional testing.
The recall is for a potential manufacturing error in the cathode component that may not meet specifications. However, all devices passed final functional testing, so the risk is low and not expected to cause serious injury.
Patients with Medtronic CRT-D devices who received the specific serial numbers listed in the recall are affected. Those with the recalled models are most at risk.
Check if your device has the serial numbers RTK601865S, RTK601825S, or RTK601828S. The product is a Cobalt Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
Compare your device's serial number to the listed ones: RTK601865S, RTK601825S, or RTK601828S.
Medtronic recalls these specific CRT-D devices due to a potential manufacturing error in the cathode component, though all devices passed final functional testing.
No, the recall does not require stopping use; the devices passed functional testing and the risk is low.
Check your device's serial number against the listed ones: RTK601865S, RTK601825S, or RTK601828S.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1480-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1480-2022 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.
