Medtronic recalls Open Pivot Aortic Valve Graft (REF 502AG25, size 25mm) due to label mislabeling as aortic when it's actually mitral. This could cause incorrect medical use.
Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.
“Medtr: Open Pivot Aortic Valve Graft Recall - Label Mislabeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65858-medtr-open-pivot-aortic-valve-graft-recall-label-mislabeling-risk. Based on FDA recall #Z-1533-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1533-2020%22&limit=1).
The FDA announced on Feb. 11, 2020, that Medtronic ATS Medical recalled two Open Pivot Aortic Valve Grafts distributed in China due to labeling errors. The hazard involves a box labeled as Aortic containing a Mitral valve.
How to tell if you have it
Brand: Medtronic
Product: Medtronic Open Pivot Aortic Valve Graft
REF: 502AG25
Size: 25 mm
UDI: 00643169297913
Serial Numbers: 935603, 935732
Distribution: China
The hazard
Medtronic received a complaint from China that the box for an Open Pivot Heart Valve was labeled as Aortic, but the product inside was Mitral. The valve itself was correctly labeled as Mitral.
Context
GovInfoNow's records show Medtronic ATS Medical has one other recall on record since Oct. 12, 2020, involving defective sterile pouch seals in Cardioblate CryoFlex Probes. Other recent recalls of similar products include the On-X Mitral Heart Valve Recall (Feb. 1, 2026) and the LeMait Artegraft Vascular Graft Recall Due to Labeling Mix-Up (Feb. 10, 2026). Additional recent recalls include the W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall regarding incorrect labeling risk on May 22, 2026.
How to tell if you have this one
Check for the product name 'Open Pivot Aortic Valve Graft', reference number 502AG25, and size 25 mm. The unique device identifier (UDI) is 00643169297913 with serial numbers 935603 or 935732.
Brand
Medtronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Label Accuracy
Verify the valve's actual type by checking the label on the box and the valve itself, which should correctly state it's a mitral valve.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1533-2020 (February 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1533-2020 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.