Medtronic recalls Open Pivot Aortic Valve Graft (REF 502AG25, size 25mm) due to label mislabeling as aortic when it's actually mitral. This could cause incorrect medical use.
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.
Medtronic is recalling a specific heart valve graft model because it was mislabeled as an aortic valve when it's actually a mitral valve. This could lead to incorrect medical procedures if used without proper identification.
The valve was labeled as aortic on the box but is actually a mitral valve. This mislabeling could cause incorrect medical procedures if the valve is used without proper identification.
Patients who received this specific heart valve graft model (REF 502AG25, size 25mm) during surgery are likely affected. Medical teams using this model for procedures are at risk of misidentification.
Check for the product name 'Open Pivot Aortic Valve Graft', reference number 502AG25, and size 25 mm. The unique device identifier (UDI) is 00643169297913 with serial numbers 935603 or 935732.
Verify the valve's actual type by checking the label on the box and the valve itself, which should correctly state it's a mitral valve.
The valve itself is safe but mislabeled as aortic when it's actually mitral. This could lead to incorrect medical procedures if not identified properly.
Look for the product name 'Open Pivot Aortic Valve Graft', reference number 502AG25, size 25 mm, UDI 00643169297913, and serial numbers 935603 or 935732.
No action is required for the valve itself, but medical teams should verify the valve's type to avoid incorrect procedures.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1533-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1533-2020 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
