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.
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📍Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/63980-medtronic-crt-d-defibrillators-recall-manufacturing-error-risk.
“Medtronic CRT-D Defibrillators Recall: Manufacturing Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63980-medtronic-crt-d-defibrillators-recall-manufacturing-error-risk. Based on FDA recall #Z-1480-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1480-2022%22&limit=1).
The FDA announced on 2020-11-05 that Medtronic Inc. is recalling Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) due to a manufacturing error that may have resulted in a cathode component being out of specification.
How to tell if you have it
Brand: Medtronic
Product: Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
UPC: 00763000178178
Serial Numbers: RTK601865S, RTK601825S, RTK601828S
The hazard
The recall addresses a manufacturing error that may have resulted in a cathode component being out of specification. The record states that all devices met final functional testing requirements.
Context
GovInfoNow's records show Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 29 other recalls on record since 2017-12-19. Other recent recalls of similar products include Medtronic CRT-D DTBC2D1 Implantable Defibrillators (2023-05-10), Medtronic CRHF Devices (2022-06-22), and Medtronic C304-HIS Device Recall (2022-04-20). Other recent recalls of similar products include Medtronic Sphere-9 Catheter Recall (2026-03-11), Bard PowerMidline Catheter Recall (2026-05-21), and Bard PowerPICC Catheters Recall (2026-05-21).
How to tell if you have this one
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).
Brand
Medtronic
Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Compare your device's serial number to the listed ones: RTK601865S, RTK601825S, or RTK601828S.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of Indiana and CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Indiana.
Recall timeline
FDA published this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1480-2022 (November 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1480-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.