Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Reported: April 1, 2020 Initiated: February 11, 2020 #Z-1533-2020
Product Description
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
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.
Details
- Recalling Firm
- MEDTRONIC ATS MEDICAL, INC.
- Units Affected
- 2 devices
- Distribution
- China
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm. Recalled by MEDTRONIC ATS MEDICAL, INC.. Units affected: 2 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2020. Severity: Moderate. Recall number: Z-1533-2020.
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