SJM Regent™ 25AGFN-756Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05414734006262), received between May 1, 2019 and Apr 2, 2026 — classified as 2 deaths, 12 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 reports).

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

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25 MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. THE TEST LEAFLET FUNCTION WAS TESTED USING A VALVE GAGE. DURING PROCEDURE, A DIFFICULTY IN VALVE LEAFLET OPENING AND CLOSING WAS NOTED. THE VALVE WAS REMOVED AND REPLACED WITH A 25 MM NON-ABBOTT VALVE WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769082 ↗
• MalfunctionJan 30, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT SURGERY DUE TO SEVERE AORTIC STENOSIS. THE LEAFLET FUNCTION WAS TESTED USING LEAFLET TESTER. DURING PROCEDURE, WHEN THE VALVE WAS SUCCESSFULLY IMPLANTED, THE PHYSICIAN FOUND THAT THE VALVE LEAFLETS WERE NOT OPENING PROPERLY DUE TO THE OBSTRUCTION OF TISSUE STRUCTURE UNDER THE VALVE. THE REGENT VALVE WAS REMOVED AND REPLACED BY A NON-ABBOTT MECHANICAL VALVE WHILE PATIENT ON BYPASS. THE OPERATION WAS FINALLY COMPLETED, AND THE PATIENT WAS IN STABLE CONDITION. THE CARDIOPULMONARY BYPASS TIME WAS PROLONGED, YET IT DID NOT CAUSE ANY SIGNIFICANT ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222098 ↗
• MalfunctionJan 15, 2026Incomplete Coaptation

  It was reported that on (b)(6) 2025, a 25mm SJM Regent Heart Valve w/ Flex Cuff was chosen for a Aortic valve replacement surgery due to severe aortic stenosis. The leaflet function was tested using a leaflet tester and confirmed it was moving normally. During the operation, when the valve was successfully implanted, the physician found that the valve leaflets were not opening properly due to the obstruction of tissue structure under the valve. So the Regent valve was removed and replaced by another 25mm SJM Regent Heart Valve w/ Flex Cuff while patient on bypass. The operation was finally completed. The cardiopulmonary bypass time was prolonged, yet it did not cause any significant adverse effects. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085804 ↗
• MalfunctionDec 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. DURING PROCEDURE, THE VALVE WAS SIZED USING A DEDICATED SIZER, BUT THERE WAS RESISTANCE, AND THE IMPLANTATION COULD NOT BE PERFORMED. THE SIZE WAS REDUCED, AND A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS CHOSEN AND INSERTED. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES, AND THE PATIENT REMAINED STABLE POSTOPERATIVELY. THE PROCEDURE TIME WAS EXTENDED, BUT THERE WAS NO HEALTH DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716306 ↗
• MalfunctionJul 14, 2025Fracture; Fracture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501503 ↗
• MalfunctionDec 23, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION, THE LEAFLETS WERE MOVING NORMALLY. THE LEAFLETS WERE TESTED MANUALLY BY THE PHYSICIAN. DURING PROCEDURE, THE VALVE WAS UNABLE TO ADJUST DIRECTION AFTER IMPLANT; THE OPENING AND CLOSING WERE NOT SATISFACTORY. THE VALVE WAS REMOVED FROM THE PATIENT. UPON REMOVAL FROM THE PATIENT, THE LEAFLETS WERE TESTED AGAIN AND THEY HAD SLIGHTLY LIMITED LEAFLET MOVEMENT. THEREFORE, THE VALVE WAS EXCHANGED FOR A NEW 25MM UNKNOWN MANUFACTURER VALVE THAT WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO HAVE RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21000627 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, A 25MM REGENT HEART VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2023, AN AORTIC VALVE ENDOCARDITIS WAS REPORTED. THEN ON (B)(6) 2024, AN AORTIC VALVE REPLACEMENT WAS PERFORMED. AFTER THE PROCEDURE, THE PATIENT REMAINED IN THE OPERATING ROOM. THEN, ON (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Endocarditis

  MAUDE report 20487410 ↗
• DeathAug 2, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2008, A 25MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT PASSED AWAY; HOWEVER, THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE VALVE. IN ADDITION, THERE IS NO INDICATION THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE VALVE. IN ADDITION, THERE IS NO INDICATION THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19897756 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2013, A REGENT AORTIC MECHANICAL HEART VALVE (SERIAL: (B)(6)) WAS IMPLANTED. ON AN UNKNOWN DATE THE PATIENT SUFFERED TWO STROKES.

  Patient problems: Stroke/CVA

  MAUDE report 19784297 ↗
• InjuryMar 16, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6)2024, A 25MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. THE VALVE WAS IMPLANTED. IMMEDIATELY AFTER THE IMPLANT, IT WAS NOTED THAT THERE WAS OPENING FAILURE OF THE LEAFLET AND THE VALVE WAS EXPLANTED. A NEW 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918965 ↗
• MalfunctionOct 16, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED. IT WAS REPORTED THE VALVE HAD STUCK LEAFLETS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940963 ↗
• InjuryOct 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  USER FACILITY MEDWATCH REPORT MW5145136 RECEIVED THAT STATES THAT " AORTIC VALVE WAS IMPLANTED IN A PATIENT AND DID NOT FUNCTION PROPERLY. REQUIRED EXPLANTATION BY SURGEON. VALVE WAS RETURNED TO MANUFACTURER FOR FURTHER INVESTIGATION. IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM REGENT AORTIC MECHANICAL VALVE WAS CHOSEN FOR IMPLANT. AFTER THE DEVICE WAS IMPLANTED, IT WAS NOTED THAT THE DEVICE DID NOT FUNCTION PROPERLY. THE DEVICE WAS EXPLANTED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895002 ↗
• InjurySep 5, 2023Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS CHOSEN FOR IMPLANT FOR AN AORTIC VALVE REPLACEMENT. AT THE TIME OF DEVICE PREPARATION, THE LEAFLETS WERE MOVING NORMALLY WHEN TESTED USING A BLUE LEAFLET TESTER. AFTER THE DEVICE WAS IMPLANTED AND THE PATIENT WAS REMOVED FROM BYPASS, IT WAS NOTED THAT THE AORTIC VALVULAR GRADIENT WAS 40MMHG. ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), BOTH LEAFLETS APPEARED TO BE FUNCTIONING. THE PATIENT WAS PLACED ON BYPASS AGAIN, AND THE VALVE WAS EXPLANTED AND REPLACED WITH A 23MM NON-ABBOTT VALVE. AFTER THE VALVE WAS EXPLANTED, THE LEAFLET FUNCTION WAS TESTED AGAIN. IT WAS NOTED THAT ONE OF THE LEAFLETS HAD RESISTANCE WITH MOVEMENT. FOLLOWING THE PROCEDURE, THE PATIENT HAD MILD RIGHT VENTRICULAR DYSFUNCTION AND PNEUMONIA, AND THE HOSPITALIZATION WAS EXTENDED. THE PATIENT STATUS WAS STABLE.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure; Pneumonia

  MAUDE report 17685988 ↗
• MalfunctionJan 12, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS CHOSEN FOR IMPLANT. THE PATIENT WAS PLACED ON EXTRACORPOREAL CIRCULATION FOR THE DURATION OF THE PROCEDURE. DURING DEVICE PREPARATION THE VALVE WAS TESTED, AND THE LEAFLETS WERE MOVING NORMALLY. AFTER THE VALVE WAS IMPLANTED, IT WAS OBSERVED THAT THE VALVE LEAFLETS HAD DIFFICULTY OPENING. THE DEVICE WAS REPLACED WITH A 25MM NON-ABBOTT BIOLOGICAL VALVE TO RESOLVE THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, AND NO PATIENT CONSEQUENCES WERE REPORTED. THE PATIENT WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16152903 ↗
• InjuryDec 12, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM SJM REGENT HEART VALVE W/FLEX CUFF WAS SELECTED FOR IMPLANTATION. DURING IMPLANTATION, IT WAS ATTEMPTED TO ROTATE THE VALVE, AND IT WOULD NOT ROTATE. THE LEAFLETS WERE TESTED WITH THE LEAFLET TESTER AND THEY WORKED AS INTENDED. THE PATIENT WAS TAKEN OFF BYPASS, AND THE LEAFLETS WERE CHECKED AGAIN. THE LEAFLETS WERE NO LONGER WORKING AS INTENDED. THE PATIENT WAS PUT BACK ONTO BYPASS AND THE DEVICE WAS EXPLANTED. A NEW 25MM SJM REGENT HEART VALVE W/FLEX CUFF WAS IMPLANTED SUCCESSFULLY. THE PATIENT IS REPORTED TO BE RECOVERING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959221 ↗
• DeathOct 25, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2008, A 25MM REGENT AORTIC MHV, FLEX C UFF WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022 IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO THE HEART VALVE. THE CAUSE OF THE DEATH IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15669464 ↗
• InjuryJun 28, 2022Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2021 A 25MM REGENT AORTIC MECHANICAL HEART VALVE (MHV) WAS CHOSEN FOR IMPLANT. THE PATIENT HAD DEVELOPED SYMPTOMS OF CHEST TIGHTNESS, PALPITATIONS, SHORTNESS OF BREATH AND CHEST PAIN. SOMETIME IN (B)(6) OF 2022, A PERIVALVULAR LEAK (4MM) WAS DISCOVERED. ON (B)(6) 2022 THE VALVE WAS EXPLANTED AND BICUSPID AORTIC VALVE MALFORMATION WAS REPORTED. THE PATIENT'S AORTIC VALVE HAS ONLY TWO LOBES, THE OPEN VALVE ORIFICE AREA HAD DECREASED, THE BLOOD FLOW FROM THE LEFT VENTRICLE TO THE AORTA WAS BLOCKED. A NEW, 23MM REGENT AORTIC MHV WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO HAVE BEEN STABLE.

  Patient problems: Angina; Arrhythmia; Dyspnea

  MAUDE report 14846562 ↗
• InjuryMay 18, 2022Perivalvular Leak; Physical Resistance/Sticking; Perivalvular Leak; Physical Resistance/Sticking

  IT WAS REPORTED A 25MM REGENT AORTIC MECHANICAL HEART VALVE WAS CHOSEN FOR PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE AFTER THE PATIENT CAME OFF CARDIOPULMONARY BYPASS (CPB) A TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) WAS PERFORMED WHICH REVEALED A SIGNIFICANT A LEAK. IT APPEARED THE INSIDE SEWING RING AND ONE OF THE LEAFLETS WAS STUCK AND WAS NOT MOVING NORMALLY. THE PATIENT WAS RE-OPENED AND THE VALVE WAS INSPECTED. THE PROBLEM WITH THE VALVE WAS NOT CLEARLY IDENTIFIED. THE PHYSICIAN ROTATED THE VALVE AND CLOSED THE PATIENT WAS CLOSED AGAIN. THE TOE WAS REPEATED WHICH REVEALED A SEVERE LEAK WAS STILL PRESENT. THE DECISION WAS MADE TO EXPLANT THE VALVE AND A NEW UNKNOWN SIZE REGENT AORTIC MECHANICAL HEART VALVE WAS IMPLANTED. ANOTHER TOE WAS PERFORMED REVEALING THE VALVE WAS SEATED AND FUNCTIONING AS INTENDED WITH NO LEAKS. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL AT THE TIME OF REPORT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 14430882 ↗
• InjuryMar 17, 2021Obstruction of Flow; Biocompatibility; Obstruction of Flow; Biocompatibility

  ON (B)(6) 2021, A PATIENT HAD UNDERGONE AN IMPLANT PROCEDURE OF A 25MM REGENT. ON (B)(6) 2021, THE PATIENT WAS BROUGHT BACK FOR AN EMERGENT REDO AVR PROCEDURE. ONE OF THE LEAFLETS OF THE REGENT VALVE WAS NOT PIVOTING PROPERLY, THIS CAUSED A LARGE JET TO COME THROUGH, AND ONE LEAFET APPEARED TO NOT OPEN. THE LEAFLET APPEARED TO HAVE THROMBOSIS ON IT. DR. (B)(6) REPLACED THIS VALVE WITH AN EDWARDS MAGNA EASE.

  Patient problems: Thrombosis/Thrombus; Valvular Insufficiency/ Regurgitation

  MAUDE report 11507903 ↗
• InjuryAug 3, 2020Backflow; Incomplete Coaptation; Backflow; Incomplete Coaptation

  ON (B)(6) 2020 . A PATIENT HAD AN ECHOCARDIOGRAM PERFORMED FOR AN UNRELATED REASON AND IT REVEALED THE PATIENT HAD SIGNIFICANT REGURGITATION AND A GRADIENT OF 25MMHG. THE PATIENT WAS GIVEN VITAMIN K FOR THE CONCERN OF CLOT FORMATION. UPON EXPLANT THERE WAS NO TISSUE IMPINGING ON THE VALVE OR ANY CLOTS OBSERVED. UPON REVIEW, IT LOOKED AS THOUGH THEY LEAFLETS WERE OPENING/CLOSING IN AN ASYMMETRICAL MANNER AND HENCE THE DECISION TO REMOVE AND PUT IN A MASTERS HP VALVE.

  Patient problems: Aortic Regurgitation; Thrombus

  MAUDE report 10358557 ↗
• MalfunctionAug 9, 2019Difficult to Insert; Difficult to Insert

  ON (B)(6) 2019, A 25 MM REGENT HEART VALVE WAS SELECTED FOR IMPLANT. DURING IMPLANT, THE PHYSICIAN WAS UNABLE TO GET THE VALVE TO ROTATE AND EXCHANGED THE VALVE FOR ANOTHER UNKNOWN VALVE. DUE TO THE VALVE UNABLE TO ROTATE, THERE WAS A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8878866 ↗
• InjuryJul 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, AN AORTIC VALVE REPLACEMENT PROCEDURE WAS PERFORMED AND A 25MM REGENT VALVE WAS IMPLANTED. DURING TESTING OF THE VALVE, A LEAFLET OF THE VALVE DISLODGED AND FELL INTO THE LEFT VENTRICLE. DISSECTION OF THE LEFT ATRIUM WAS PERFORMED TO REMOVE THE LEAFLET. THE LEAFLET WAS OBSERVED TO BE IN THE LEFT PULMONARY VEIN AND WAS REMOVED USING A FORCEPS. THE PHYSICIAN CONFIRMED THAT NO LEAFLET PIECES REMAINED IN THE PATIENT FOLLOWING REMOVAL. THE DEVICE WAS EXPLANTED AND EXCHANGED FOR A 25MM CARBOMEDICS ORBIS VALVE AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. PER THE SITE, THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE; HOWEVER, THE PROCEDURE TIME WAS SIGNIFICANTLY EXTENDED DUE TO THE VALVE REPLACEMENT. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8773997 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AN UNKNOWN DATE, A 25MM REGENT VALVE WAS IMPLANTED. ON (B)(6) 2019, THE VALVE WAS EXPLANTED DUE TO IMPROPER LEAFLET FUNCTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8569289 ↗