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Terminated

Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

FDA Recall Z-1533-2020 · Posted None

Recalling FirmMEDTRONIC ATS MEDICAL, INC.
Recall StatusTerminated
Product CodeLWQ
Date Initiated2020-02-11
Date Terminated2022-03-04
Product Quantity2 devices

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

China

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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