Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1533-2020 — Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

U.S. FDA — Device Enforcement · United States · 2020-02-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1533-2020
Date of alert
2020-02-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
MEDTRONIC ATS MEDICAL, INC.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00643169297913
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.