SJM Regent™ 25AGN-751Recalls & reported problems
St. Jude Medical, Inc. · Aortic Rotatable Mechanical Heart Valve · Class 3 · Implant
All models of SJM Regent (9)
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 05414734006279), received between Oct 30, 2023 and Oct 30, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- Hypoxia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 30, 2023Off-Label Use; Off-Label Use
THE ARTICLE, ¿REDO MITRAL VALVE REPLACEMENT IN AN ADULT ATRIOVENTRICULAR SEPTAL DEFECT HEART WITH SEVERE PULMONARY HYPERTENSION: A CASE STUDY¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 37-YEAR-OLD FEMALE WITH SEVERE PULMONARY HYPERTENSION WITH PRIOR CARDIAC SURGERY TO TREAT ATRIOVENTRICULAR SEPTAL DEFECT, PRIOR MITRAL VALVE REPLACEMENT WITH A 29MM PERIMOUNT VALVE (EDWARDS LIFESCIENCES) FOR MITRAL REGURGITATION, PRIOR TRICUSPID SUTURE ANNULOPLASTY, AND EPICARDIAL PACING LEADS IMPLANT PROCEDURE FOR TRICUSPID REGURGITATION, AND PACEMAKER IMPLANTED FOR ATRIOVENTRICULAR BLOCK. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH DYSPNEA. IT WAS THEN REPORTED THREE YEARS LATER ON AN UNKNOWN DATE, THE PATIENT WAS REFERRED TO A HOSPITAL FOR SEVERE PULMONARY HYPERTENSION, HEART FAILURE, CARDIOMEGALY, ENLARGED PULMONARY ARTERY, SEVERE BIOPROSTHETIC CALCIFICATION, AND LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION. A DECISION WAS MADE TO PERFORM REDO MITRAL VALVE REPLACEMENT WITH A 25MM SJM REGENT MECHANICAL VALVE AND TRICUSPID VALVE ANNULOPLASTY WITH A 27MM SJM TAILOR BAND. IT WAS ALSO REPORTED DURING A CONCOMITANT AORTIC VALVE REPAIR PROCEDURE, A 17MM SJM REGENT MECH
Patient problems: Hypoxia
MAUDE report 18030427 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page