Z-1533-2020Class II

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

Name: Z-1533-2020 Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Creator: Medtronic Ats Medical, Inc.
Published: 2020-02-11
License: https://open.fda.gov/license/

Medtronic, Inc. (Minneapolis, MN 55447) / initiated 2020-02-11 / Terminated / root cause: labeling and UDI

FDA source

MEDTRONIC ATS MEDICAL, INC. began a recall of Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm on 2020-02-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1533-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-11
Posted: 2020-03-20
Terminated: 2022-03-04
Recalling firm: Medtronic, Inc. (Minneapolis, MN 55447)
Product: Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Product code: LWQ Heart-Valve, Mechanical
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.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: UDI 00643169297913, Serial Numbers: 935603, 935732

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1533-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1533-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20

Product code LWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)