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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft

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  Class 2 Device Recall Medtronic Open Pivot Aortic Valve Graft see related information
Date Initiated by Firm February 11, 2020
Create Date March 20, 2020
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = MEDTRONIC ATS MEDICAL, INC.
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