Regent™ 23AGN-751Recalls & reported problems
St. Jude Medical, Inc. · Mechanical Heart Valve · Class 3 · Implant
All models of Regent (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067044310), received between Jul 26, 2024 and Jan 5, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Intravalvular regurgitation1
- Physical Resistance/Sticking1
Patient problems
- Angina1
- Aortic Valve Insufficiency/ Regurgitation1
- No Clinical Signs, Symptoms or Conditions1
- Pleural Effusion1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2026Detachment of Device or Device Component; Intravalvular regurgitation
It was reported that on (B)(6) 2025, a 23mm Regent Heart Valve was chosen for a procedure. During procedure, the valve detached and stuck in the patients groin. The patient had severe aortic insufficiency due to the missing leaflet and consequently required an impella. The patient was reported critical. On (B)(6) 2026, the patient was reported passed away.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 23966812 ↗MalfunctionDec 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, AFTER SEWING WITH CORENOT ROTATING OF THE VALVE WAS NOT POSSIBLE, AND WAS EXPLANTED. A NEW 23 SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809824 ↗InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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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