Regent™ 23AGFN-756Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 05415067044174), received between May 10, 2024 and Sep 25, 2026 — classified as 2 deaths, 9 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Physical Resistance/Sticking

  It was reported that on (b)(6)2026, a 23mm SJM Regent Heart Valve w/Flex Cuff was chosen for a mechanical aortic valve replacement (MVR) procedure. After cardiac recurrence, it was found during esophageal ultrasound that the valve could not open and close normally, and the mechanical valve was removed. Therefore, a new A new 21mm SJM Regent Heart Valve w/Flex Cuff was re-implanted while patient on bypass and esophageal ultrasound was performed, and the implanted valve opened and closed normally. There was no delay in the procedure and the patient was reported discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896681 ↗
• MalfunctionSep 18, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817271 ↗
• MalfunctionMay 22, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS CHOSEN FOR A PROCEDURE. DURING THE OPERATION, THE VALVE LEAFLETS WERE STUCK. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255551 ↗
• MalfunctionMay 18, 2026Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2026, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. DURING IMPLANTATION, THE LEAFLET DETACHED. THE DEVICE WAS REMOVED AND A NEW 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS USED AS AN ALTERNATIVE DEVICE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25208387 ↗
• MalfunctionMay 8, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, A POOR OPENING AND CLOSING OF VALVE LEAFLETS WAS OBSERVED. THE VALVE GOT REMOVED AND A NEW 25MM VALVE GOT IMPLANTED 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 25123843 ↗
• MalfunctionMay 4, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT ON 01 APR 2026, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, A CHIPPING WAS OBSERVED AT THE VALVE CUSP. THE DEVICE WAS REMOVED AND A NEW 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN AND COMPLETED THE PROCEDURE 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 25073253 ↗
• MalfunctionFeb 6, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT (AVR) SURGERY. DURING PROCEDURE, THE CHIEF SURGEON IMPLANTED A MECHANICAL VALVE AND FOUND THAT SOME OF THE VALVE LEAFLETS HAD FALLEN OFF DURING THE EXAMINATION OF THE VALVE LEAFLET OPENING STATUS. THE FALLEN LEAFLET WAS RECOVERED FROM THE PATIENT. THEREFORE, THE MECHANICAL VALVE WAS REMOVED AND A NEW 23MMSJM REGENT HEART VALVE W/ FLEX CUFF VALVE OF THE SAME MODEL WAS IMPLANTED 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 24277436 ↗
• MalfunctionFeb 4, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2026, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE WHILE SUTURING THE VALVE, A SEWING RING TEAR WAS NOTED. THE VALVE REMOVED AND REPLACED INTRA-PROCEDURALLY, WHILE THE PATIENT WAS STILL ON BYPASS. THERE WAS A DELAY IN OVERALL PROCEDURE TIME. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260256 ↗
• MalfunctionDec 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS CHOSEN FOR A PROCEDURE. DURING THE PROCEDURE, THE USE OF VALVE WAS DISCONTINUED DUE TO AN UNUSUAL SENSATION EXPERIENCED DURING THE EMBEDDING PROCESS. A RESISTANCE WAS FELT STRONGER THAN USUAL. THE DECISION WAS BASED ON RELUCTANCE TO IMPLANT A DEVICE THAT CAUSED A LINGERING SENSE OF DISCOMFORT. A NEW 23MM EPIC SUPRA VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE 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 23851425 ↗
• MalfunctionDec 12, 2025Incomplete Coaptation; Incomplete Coaptation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790353 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS CHOSEN FOR A PROCEDURE. DURING THE PROCEDURE IN THE CARDIAC SURGERY SUITE, THE VALVE WAS FITTED. DURING THE ADJUSTMENT, THE TWO WINGS WERE DETACHED. THERE WAS NO EXCESSIVE FORCE WAS OBSERVED AT THE TIME OF THE RUPTURE. THERE WAS NO ISSUES NOTED BEFORE OPENING AND THE PACKAGING WAS INTACT. THEREFORE, THE DEFECTIVE VALVE WAS REMOVED AND REPLACED WITH A SECOND NON-ABBOTT VALVE. WHILE PATIENT ON BYPASS. THERE WAS MINOR SURGICAL DELAY WITH NO MAJOR CONSEQUENCES FOR THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617857 ↗
• MalfunctionNov 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555014 ↗
• MalfunctionOct 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. AFTER THE IMPLANTATION OF VALVE, THE LEAFLET WAS NOTED STICKING IN THE TISSUE AND IT WAS OPENING BUT NOT PROPERLY. THE PHYSICIAN EXPLANTED THE VALVE IMMEDIATELY AND IMPLANTED A NON-ABBOTT VALVE WHILE THE PATIENT WAS STILL ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337262 ↗
• MalfunctionOct 15, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE CHOSEN FOR A Y-INCISION AORTIC VALVE REPLACEMENT PROCEDURE. THE LEAFLET FUNCTION WAS TESTED BY USING A PLASTIC TESTER. AFTER IMPLANTATION OF THE VALVE, THE PHYSICIAN FOUND ONE LEAFLET OF THE VALVE COULDN'T MOVE FLEXIBLY. SO, THE PHYSICIAN HAD TO EXPLANT THE VALVE AND IMPLANTED A NEW 23MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE. THE LEAFLET FUNCTION WAS TESTED BY USING A PLASTIC TESTER. BUT THE LEAFLET OF THE 23MM VALVE COULDN'T MOVE FLEXIBLY AGAIN, THE DOCTOR HAD TO EXPLANT THE 23MM VALVE AGAIN AND A NEW 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED. THE VALVE WAS MOVED NORMALLY. THE PROCEDURE TIME WAS EXTENDED ABOUT 60 MINUTES. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286230 ↗
• InjuryJul 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM REGENT VALVE WAS SUCCESSFULLY IMPLANTED. ROTATION DIFFICULTY WAS NOTED DURING IMPLANT. AFTER CARDIAC RECURRENCE, IT WAS FOUND DURING ESOPHAGEAL ULTRASOUND THAT THE VALVE COULD NOT OPEN AND CLOSE NORMALLY THE MECHANICAL VALVE WAS REMOVED AND REPLACED WITH A 21MM REGENT VALVE TO RESOLVE THE EVENT. ESOPHAGEAL ULTRASOUND WAS PERFORMED AGAIN AND THE IMPLANTED VALVE WAS NOTED TO BE OPENING AND CLOSING NORMALLY. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS IN GOOD CONDITION AND IS IN THE POSTOPERATIVE RECOVERY PERIOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587583 ↗
• MalfunctionJul 22, 2025Incomplete Coaptation; Incomplete Coaptation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565947 ↗
• InjuryJul 7, 2025Perivalvular Leak; Incomplete Coaptation; Perivalvular Leak; Incomplete Coaptation

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 22424043 ↗
• InjuryJun 27, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM REGENT AORTIC MECHANICAL HEART VALVE WAS IMPLANTED. IT WAS REPORTED THAT THE PHYSICIAN "NOTED A DIFFERENCE IN THE PERFORMANCE OF ONE LEAFLET." ON (B)(6) 2025, PARTIAL BLOCKAGE OF ONE HEMIDISC OF THE AORTIC PROSTHESIS WAS OBSERVED. REOPERATION WAS PERFORMED AND THE VALVE WAS REPLACED WITH A 23MM NON-ABBOTT VALVE. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350560 ↗
• MalfunctionMay 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION, THE LEAFLETS WERE TESTED WITH A VALVE TESTER AND THE LEAFLETS WERE MOVING NORMALLY. DURING IMPLANT, THERE WAS POOR OPENING AND CLOSING OF THE LEAFLET OF THE VALVES AND IT WAS NOT IMPLANTED. THE VALVE WAS REMOVED FROM THE PATIENT AND UPON TESTING AGAIN, THE LEAFLETS CONTINUED TO NOT MOVE NORMALLY. A NEW, UNKNOWN SIZED NON-ABBOTT VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073695 ↗
• InjuryMay 20, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM REGENT VALVE WAS SELECTED FOR IMPLANT IN A BENTALL PROCEDURE. TEE ECHO WAS PERFORMED AND REVEALED PVL, SO THE VALVE WAS REPLACED WITH A NEW 23MM REGENT VALVE TO RESOLVE THE EVENT. THE PATIENT WASN'T REMOVED FROM BYPASS FOR THE REPLACEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22055077 ↗
• DeathMay 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A REGENT IMPLANT PROCEDURE OCCURRED. DURING THE PROCEDURE, THE CHIEF SURGEON SUTURED AN ARTIFICIAL BLOOD VESSEL AND ENLARGED THE ROOT OF THE AORTIC VALVE ANNULUS. SUBSEQUENTLY, THE CHIEF SURGEON MEASURED THE SIZE OF THE ANNULUS USING STANDARD METHODS AND DECIDED TO IMPLANT THE 23MM REGENT MECHANICAL VALVE. AFTER SUTURING, IT WAS FOUND THAT THE VALVE LEAFLETS COULD NOT BE FULLY OPENED. THE CHIEF SURGEON REPLACED THE VALVE WITH ANOTHER BRAND OF MECHANICAL VALVE TO COMPLETE THE IMPLANTATION. THERE WERE SOME CORRELATIONS WITH HEMODYNAMIC INSTABILITY AND PROCEDURAL DELAY DUE TO THE LEAFLET ISSUE. AFTER THE SURGERY, ON THE SAME DAY, THE PATIENT DIED DUE TO A RUPTURED HEART. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THEY BELIEVE THE PATIENT'S POSTOPERATIVE DEATH IS RELATED TO THE NON-ABBOTT VALVE, THE PROCEDURE, OR THE PATIENT'S COMORBIDITIES.

  Patient problems: Perforation

  MAUDE report 22002054 ↗
• MalfunctionApr 28, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS CHOSEN FOR A PROCEDURE. THE VALVE WAS IMPLANTED NORMALLY, BUT THE VALVE LEAFLETS HAD PROBLEMS OPENING AND CLOSING AFTER IMPLANTATION. THERE WERE ONLY THREE TYPES OF VALVES, 21, 23, AND 25, AVAILABLE IN THE OPERATING ROOM AT THE TIME, SO A 21MM VALVE WAS CHOSEN. THE VALVE WAS REMOVED AND REPLACED WITH A NEW 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WHILE THE PATIENT WAS STILL ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT RECOVERED TO NORMAL AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920057 ↗
• MalfunctionMar 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION, THE LEAFLETS WERE TESTED WITH A "TEST VALVE DEVICE" AND THEY WERE NOT MOVING NORMALLY. DURING IMPLANT, IT WAS OBSERVED THAT THE VALVE LEAFLETS DID NOT OPEN AND CLOSE FLEXIBLY. THE VALVE WAS REMOVED AND THE LEAFLETS WERE AGAIN TESTED OUTSIDE THE PATIENT WITH NO IMPROVEMENT TO ITS MOBILITY. A NEW 25MM MASTERS SERIES HEART COATED AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED TO BE IN NORMAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635162 ↗
• InjuryFeb 12, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. DURING PREPARATION, THE LEAFLET MOTION WAS TESTED USING A VALVE TESTER. THE VALVE WAS SUCCESSFULLY IMPLANTED. AFTER DEPLOYMENT, THE VALVE WAS TESTED FOR OPENING AND FOUND TO HAVE RESTRICTED MOBILITY OF DISCS. ONE DISC WAS TILTING AND OTHER ONE WAS NOT MOVING. THE VALVE WAS REMOVED AND REPLACED WITH A NEW 23MM SJM REGENT HEART VALVE W/ FLEX CUFF. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21369393 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. THE VALVE WAS IMPLANTED, FOUR MINUTES AFTER THE PROCEDURE, THE PHYSICIAN NOTICED OOZING OF BLOOD FROM SUTURE LINE IN THE CUFF. THE VALVE WAS EXPLANTED AND A NEW 23MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS IMPLANTED. THE PHYSICIAN MENTIONED THE WEAVING CUFF WAS THIN AND POROSITY WAS MORE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801006 ↗