MEDTRONIC ATS MEDICAL, INC. Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Brand
MEDTRONIC ATS MEDICAL, INC.
Lot Codes / Batch Numbers
UDI 00643169297913, Serial Numbers: 935603, 935732
Products Sold
UDI 00643169297913, Serial Numbers: 935603, 935732
MEDTRONIC ATS MEDICAL, INC. is recalling Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm due to 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. . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026