Regent™ 21AGFN-756Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 05415067042958), received between Jul 12, 2024 and Sep 17, 2026 — classified as 3 deaths, 8 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (17 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Detachment of Device or Device Component

  It was reported on (b)(6) 2026 a 21mm Regent Heart Valve was selected for implant. During the procedure it was noted that the leaflet dislodged intact as one piece. The leaflet was able to be removed from the patient. The device was removed and replaced with a new 21mm Regent Heart Valve. There were no adverse effects to the patient. The patient status was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805590 ↗
• DeathJun 26, 2026Perivalvular Leak; Device Stenosis; Intravalvular regurgitation

  User Facility (b)(4) received:It was reported that in 1991 an unknown 31mm St. Jude mechanical mitral valve was implanted. It was later reported that on (b)(6) 2014 a 21mm SJM Regent Heart Valve w/ Flex Cuff was implanted in the patient. The patient concomitantly received a 32mm non-Abbott annuloplasty ring for tricuspid ring repair. In (b)(6) 2023, patient was admitted to hospital with heart failure with preserved ejection fraction. A transesophageal echocardiogram (TOE) reported a well seated 21mm Regent valve with two trivial paravalvular leaks. The 31mm unknown St. Jude mechanical mitral valve was noted to be well seated with no obvious paravalvular leak or regurgitation. On (b)(6) 2024, an echocardiography report records showed two mild aortic paravalvular leaks with peak velocity 3.74 m/s, mean/max gradient 31/56 mmHg, and Doppler Velocity Index (DVI) 0.37. A cardiology letter dated (b)(6) 2025 reported degenerative prosthetic aortic valve disease with mild to moderate transvalvular leak, moderate mixed tricuspid stenosis/regurgitation, and fluid-retention symptoms. In (b)(6), hospital and coroner-related records showed a posterior fossa hemorrhagic event in the context of an

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure; Stroke/CVA

  MAUDE report 25635680 ↗
• MalfunctionMay 15, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A SURGERY. DURING PROCEDURE, THE DOCTOR FOUND OUT THE LOBE HAS A STUCK PROBLEM. AN UNKNOWN SIZE REGENT WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE PATIENT ON BYPASS. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE, NO ADVERSE CLINICAL IMPACT ON THE PATIENT. THE PATIENT WAS REPORTED STABLE AND RECOVERING SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183687 ↗
• MalfunctionMay 12, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 21 MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. DURING PROCEDURE, THE VALVE WAS IMPLANTED HOWEVER, LEAFLET MOBILITY WAS POOR AND THE VALVE WAS EXPLANTED. A NEW 19 MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS SUBSEQUENTLY IMPLANTED, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUES WHILE PATIENT ON BYPASS. THE SIZING WAS PERFORMED USING A DEDICATED SIZER. THE ANNULAR DIAMETER WAS ALSO EQUIVALENT TO 21 MM. THE POSTOPERATIVE COURSE WAS FAVORABLE. THE PATIENT WAS REPORTED STABLE. THERE WAS NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156167 ↗
• DeathApr 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2026, A 21 MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. INTRA-OPERATIVELY THE LEAFLET GOT ESCAPED AND CANNOT BE FOUND IN PATIENT. AFTER A PROLONGED CARDIOPULMONARY BYPASS TIME USED FOR SEARCHING FOR THE DISLODGED LEAFLET, THE DISLODGED LEAFLET COULD NOT BE LOCATED. A REPLACEMENT VALVE WAS IMPLANTED. POST-IMPLANT, THE PATIENT WENT ON TO DEVELOP SEPSIS AND IMAGING DEMONSTRATED THAT THE DISLODGED LEAFLET WAS LOCATED WITHIN THE ILIAC ARTERY. THERE WERE PLANS TO RETRIEVE THE DISLODGED LEAFLET FROM THE ILIAC ARTERY, BUT UNFORTUNATELY DUE TO THE CRITICAL CONDITION OF THE PATIENT FROM THE SEPSIS THE PATIENT PASSED AWAY BEFORE THIS WAS POSSIBLE. IT IS ESTIMATED THAT THE PATIENT DIED WITHIN SEVERAL WEEKS POST-IMPLANT. THE CAUSE OF DEATH IS UNCERTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Sepsis

  MAUDE report 24839516 ↗
• MalfunctionJan 30, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2026, A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING THE SURGERY, THE SURGEON WAS SUTURING THE MECHANICAL VALVE 21 REGENT. WHILE CHECKING THE OPENING AND CLOSING OF THE VALVE LEAFLETS DURING SUTURING, A SMALL TEAR SUDDENLY APPEARED IN ONE OF THE LEAFLETS. THE SURGERY WAS IMMEDIATELY STOPPED, THE VALVE WAS REMOVED, AND A NON-ABBOTT VALVE WAS USED TO CONTINUE THE OPERATION WHILE PATIENT ON BYPASS. THE PATIENT WAS REPORTED NORMAL AND HAD NO EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221306 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809817 ↗
• MalfunctionDec 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716318 ↗
• MalfunctionDec 4, 2025Fracture; Fracture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716275 ↗
• MalfunctionNov 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A AORTIC VALVE MECHANICAL VALVE REPLACEMENT SURGERY. AFTER THE MECHANICAL VALVE WAS IMPLANTED, ATTEMPTS WERE MADE TO ROTATE THE LEAFLETS TO ADJUST THE DIRECTION, BUT IT FAILED AFTER MULTIPLE TRIES. SO THE SUBSEQUENT SURGICAL PROCEDURES COULD NOT PROCEED NORMALLY. A NEW 21MM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN AND THE REST OF THE SURGERY WENT SMOOTHLY. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480040 ↗
• MalfunctionOct 10, 2025Incomplete Coaptation; Incomplete Coaptation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23265815 ↗
• InjuryOct 3, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2016, A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE, IT WAS NOTED A RENDERED IMMOBILE DUE TO RESTRICTED MOTION OF ONE LEAFLET TIP. THE REMAINING LEAFLET TIP ALSO APPEARED TO BE INCOMPLETELY OPENED. ON (B)(6) 2025, THE VALVE WAS EXPLANTED AND REPLACED WITH A NON-ABBOTT VALVE. THE PATIENT WAS REPORTED UNSTABLE.

  Patient problems: Insufficient Information

  MAUDE report 23209221 ↗
• MalfunctionJul 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION, THE LEAFLETS WERE MOVING NORMALLY. POST-IMPLANT, VALVE FUNCTION WAS TESTED AND IT WAS OBSERVED THAT THE LEAFLET COULD NOT OPEN AND CLOSE COMPLETELY. THE VALVE WAS REMOVED AND WHEN TESTED AGAIN OUTSIDE THE PATIENT, THE LEAFLETS CONTINUED TO HAVING ISSUES OPENING AND CLOSING. A NEW 21MM REGENT AORTIC MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT STATUS WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22533598 ↗
• MalfunctionJul 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION, THE LEAFLETS WERE MOVING NORMALLY. POST-IMPLANT, THE HEART WAS RE-BEAT AND IT WAS OBSERVED THAT THE VALVE LEAFLET GOT STUCK WHEN TESTED WITH A VALVE TESTER. THE VALVE WAS REMOVED AND TESTED AGAIN, IN WHICH THERE WAS NORMAL OPENING AND CLOSING OF THE VALVE LEAFLETS. THE USER ALLEGED ANNULAR EXTRUSION WAS THE CAUSE OF THE LEAFLET'S BEING STUCK WHILE INSIDE THE PATIENT. THE VALVE WAS REPLACED WITH A NEW 21MM REGENT AORTIC MECHANICAL HEART VALVE, WHICH WAS SUCCESSFULLY IMPLANT. THE PATIENT WAS REPORTED TO HAVE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470683 ↗
• InjuryJul 4, 2025Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM REGENT HEART VALVE WITH FLEX CUFF WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE THAT THE LEAFLETS OF THE FAILED TO OPEN OR CLOSE. IT'S NOTED DEVICE PREPARATION THAT THE LEAFLETS WERE NOT MOVING NORMALLY WHEN TESTED USING A CLAMP. THE DECISION WAS MADE TO EXPLANT THE VALVE AND REPLACE IT WITH ANOTHER ONE OF THE SAME SIZE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS NOT TAKEN OFF BYPASS AND PLACED BACK ON BYPASS DUE TO THIS EVENT. AFTER THE VALVE WAS NO LONGER IN THE ANNULUS, THE USER DID NOT TEST THE LEAFLETS. THE PATIENT WAS TAKING WARFARIN AT THE TIME OF PROCEDURE. THE PATIENT DID NOT HAVE ANY CLINICAL SIGNS OR SYMPTOMS DURING OR AFTER THIS EVENT. THERE WAS NO INITIAL OR PROLONGED HOSPITALIZATION DUE TO THIS EVENT. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22405204 ↗
• MalfunctionJul 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. THE PATIENT HAD A PAST MEDICAL HISTORY OF SEVERE AORTIC STENOSIS. THE VALVE WAS SIZED WITH A 907 MECHANICAL HEART VALVE SIZER. DURING DEVICE PREPARATION, LEAFLET FUNCTION WAS NOT TESTED. AFTER THE VALVE HAD BEEN IMPLANTED, IT WAS OBSERVED THAT THE LEAFLETS WERE NOT OPENING PROPERLY WHILE TESTED WITH A LEAFLET TESTER. THE LEAFLETS WERE NOT OPENING PROPERLY DUE TO THE OBSTRUCTION OF TISSUE STRUCTURE UNDER THE VALVE. THEREFORE, THE VALVE WAS REMOVED. UPON REMOVAL, THE LEAFLETS WERE TESTED AGAIN AND WERE "STILL NOT MOVING NORMALLY." A NEW 21MM REGENT AORTIC MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387108 ↗
• MalfunctionJun 25, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING PREPARATION, THE USER TEST THE LEAFLETS' FUNCTION USING RUBBER HOSE AND IT WAS MOVING NORMALLY. IMMEDIATELY AFTER BEING IMPLANTED IN THE HUMAN BODY, IT WAS NOTED THAT THE VALVE DOES NOT CLOSE PROPERLY. THE VALVE WAS REMOVED AND REPLACED WITH A NEW 22MM NON-ABBOTT VALVE WHILE THE PATIENT WAS STILL ON BYPASS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331130 ↗
• MalfunctionJun 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, THE 36-YEAR-OLD PATIENT UNDERWENT AORTIC VALVE REPLACEMENT SURGERY AND MITRAL VALVE REPLACEMENT SURGERY DUE TO MITRAL STENOSIS AND SEVERE AORTIC STENOSIS. A 27MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE AND A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WERE CHOSEN FOR A PROCEDURE. THE PHYSICIAN DID NOT TEST THE LEAFLET AT THE TIME OF DEVICE PREPARATION. DURING PROCEDURE, WHEN THE VALVE WAS SUCCESSFULLY IMPLANTED, THE PHYSICIAN FOUND THAT THE VALVE LEAFLETS OF REGENT WERE NOT OPENING PROPERLY. AFTER THE EXPLANT, THEY FOUND THE LEAFLETS STILL NOT MOVING NORMALLY. THE REGENT VALVE WAS REMOVED AND REPLACED BY NEW 21MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WHILE THE PATIENT WAS STILL ON BYPASS. THE OPERATION WAS FINALLY COMPLETED, AND THE PATIENT WAS IN STABLE CONDITION. THERE OPERATION TIME WAS PROLONGED, NO OTHER ADVERSE EFFECTS WERE CAUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292373 ↗
• MalfunctionJun 19, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM REGENT VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ROTATING THE VALVE. AT SOME POINT, THERE WAS LEAFLET DETACHMENT FROM THE DEVICE. THE LEAFLET WAS REMOVED FROM THE PATIENT AND A NEW 21MM REGENT VALVE WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289835 ↗
• MalfunctionJun 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM REGENT VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHILE INSERTING THE VALVE, THE VALVE LEAFLETS SNAPPED OFF. THE DEVICE WAS REPLACED WITH ANOTHER REGENT VALVE TO RESOLVE THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159183 ↗
• MalfunctionApr 28, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM REGENT AORTIC VALVE WAS SELECTED FOR IMPLANT. THE PATIENT REQUIRED A DOUBLE VALVE REPLACE DUE TO RHEUMATIC HEART DISEASE. THE MITRAL VALVE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE AORTIC PROCEDURE WAS THEN DONE AND THE VALVE WAS IMPLANTED. WHEN THE LEAFLETS WERE TESTED USING THE LEAFLET TESTER, IT WAS FOUND THAT THEY DID NOT OPEN EASILY. IT WAS NOTED THAT THEY WERE TESTED EARLIER AND DIDN'T HAVE ANY ISSUES. THE PHYSICIAN DECIDED TO ROTATE THE VALVE WITH THE VALVE HOLDER AND THE VALVE FELT STUCK AND WOULDN'T ROTATE. DURING THIS PROCESS THE LEAFLET DISLODGED AS ONE PIECE. THE VALVE AND LEAFLET WERE REMOVED AND REPLACED WITH ANOTHER 21MM REGENT AORTIC VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922119 ↗
• InjuryApr 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2008, A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2025, THE VALVE WAS EXPLANTED AND A NON-ABBOTT VALVE WAS IMPLANTED AND PATIENT WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) MACHINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21745852 ↗
• InjuryFeb 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2006, A 31MM SJM MASTERS SERIES MECHANICAL HEART VALVE AND ON AN UNKNOWN DATE A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2024, BOTH THE VALVES WERE EXPLANTED AND A NEW 27MM NON-ABBOTT VALVE AND 31MM EPIC MITRAL VALVE WERE IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 21323017 ↗
• InjuryJan 27, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT SURGERY. THE LEAFLET FUNCTION WAS TESTED WITH A VALVE TESTER LT100. THE LATEST INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.5. 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 VALVE WAS REMOVED AND A NEW NON-ABBOTT VALVE WAS IMPLANTED. THE OPERATION TIME WAS PROLONGED, BUT DID NOT CAUSE SIGNIFICANT ADVERSE EVENTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241452 ↗
• MalfunctionDec 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 21MM REGENT VALVE WAS SELECTED FOR IMPLANT. AFTER THE VALVE WAS IMPLANTED, IT WAS NOTED THAT THE LOBE OF THE VALVE WAS STUCK. THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER 21MM REGENT VALVE TO RESOLVE THE EVENT. THERE WERE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO REPORTED ADVERSE EVENT DUE TO THE ADDITIONAL OPERATING TIME. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20989263 ↗