SJM™ Masters Series 25ATJ-503Recalls & reported problems
St. Jude Medical, Inc. · Aortic PTFE 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 05414734022217), received between Nov 1, 2019 and Nov 1, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2019, A BENTALL PROCEDURE WAS PERFORMED AND A 25MM SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF WAS IMPLANTED AND A J GRAFT SHIELD NEO VALSALVA (JNVT-2809, SERIAL# (B)(4)) WAS CONCOMITANTLY IMPLANTED. AFTER CLOSING THE PATIENT'S CHEST, THE LEAFLETS STUCK IN THE CLOSED STATE. THE PHYSICIAN RE-OPENED THE PATIENT'S CHEST AND THE VALVE WAS ROTATED APPROXIMATELY 30 DEGREES. BY SHAKING THE HEART, THE LEAFLET STARTED OPERATING AGAIN. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE VALVE. IT WAS NOTED THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) AFTER THE PROCEDURE, BUT THE USER DOES NOT ASSOCIATE THAT WITH THE VALVE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9265607 ↗
Other HEART-VALVE, MECHANICAL devices
- On-X Mitral Heart Valve with Conform-X Sewing Ring ONXMC-25/33On-X Life Technologies, Inc. · Heart-Valve, Mechanical1 recall1 death34 reports
- SJM Regent™ AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths70 reports
- SJM Regent™ AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL5 deaths66 reports
- SJM Regent™ 23AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths44 reports
- CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-021Corcym Srl · HEART-VALVE, MECHANICAL7 deaths37 reports
- Regent™ 21AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths35 reports
- Regent™ 23AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL2 deaths33 reports
- Regent™ 19AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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