Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft

• Date Initiated by Firm: February 11, 2020
• Create Date: March 20, 2020
• Recall Status: Terminated on March 04, 2022
• Recall Number: Z-1533-2020
• Recall Event ID: 85092
• PMA Number: P990046
• Product Classification: Heart-valve, mechanical - Product Code LWQ
• Product: Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
• Code Information: UDI 00643169297913, Serial Numbers: 935603, 935732
• Recalling Firm/ Manufacturer: MEDTRONIC ATS MEDICAL, INC.; 3800 Annapolis Ln N; Plymouth MN 55447-5439
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Labeling mix-ups
• Action: On 11-Feb-2020, a Medtronic field representative notified the 1 (one) consignee who had received affected product via telephone. The consignee was asked to quarantine and return the affected product.
• Quantity in Commerce: 2 devices
• Distribution: China
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LWQ