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SJM™ Masters Series 25AECJ-502Recalls & reported problems

St. Jude Medical, Inc. · Aortic Expanded Rotatable Mechanical Heart Valve · Class 3 · Implant

All models of SJM Masters Series (27)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734053907), received between Sep 16, 2019 and Sep 16, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 16, 2019Fracture; Fracture

    ON (B)(6) 2019, A 25MM MASTERS VALVE WAS IMPLANTED. AFTER THE PHYSICIAN CUT THE RETAINING SUTURES AND TRIED TO ROTATE THE VALVE WITH THE HOLDER, IT WAS FOUND THAT ONE OF THE LEAFLET HAD FRACTURED INTO MULTIPLE PIECES. ALL OF THE BROKEN LEAFLETS ARE RECOVERED. THE VALVE WAS REMOVED AND A 21MM MASTERS VALVE (B)(4) WAS IMPLANTED INSTEAD. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED TO BE STABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9074084 ↗

Other HEART-VALVE, MECHANICAL devices

All HEART-VALVE, MECHANICAL devices →

Sources and updates

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