SJM Regent™ 23AGN-751Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05414734006101), received between Sep 18, 2020 and Jan 31, 2024 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6)2023, A 23MM REGENT VALVE WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE, BOTH OF THE LEAFLETS WERE DISLODGED AS A SINGLE PIECE AND WAS RECOVERED FROM THE PATIENT. A 23MM REGENT VALVE WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS STABLE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615100 ↗
• MalfunctionAug 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM SJM REGENT HEART VALVE WAS CHOSEN FOR IMPLANT. AFTER THE VALVE WAS IMPLANTED, IT WAS FOUND THE VALVE COULD NOT BE ROTATED. IT WAS REPORTED THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT 90 DEGREE ANGLE AND NO OTHER TOOL WAS USED TO POSITION OR ROTATE THE VALVE. A DECISION WAS MADE TO EXPLANT THE DEVICE AND REPLACE WITH A 21MM SJM REGENT HEART VALVE. THE REPLACEMENT VALVE WAS SUCCESSFULLY IMPLANTED WITH NO ADVERSE PATIENT CONSEQUENCES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574713 ↗
• MalfunctionJun 14, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM SJM REGENT HEART VALVE WAS CHOSEN FOR IMPLANT. AFTER THE VALVE WAS SUTURED IN PLACE, THE VALVE WAS ROTATED USING THE HOLDER HANDLE WHILE INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. THE VALVE WAS IN THE CLOSED POSITION WHEN IT WAS ROTATED. THE PHYSICIAN FELT RESISTANCE WHILE ROTATING THE VALVE, AND THE LEAFLETS FRACTURED INTO MULTIPLE PIECES. IT WAS REPORTED ALL PIECES WERE RECOVERED FROM THE PATIENT. THERE WAS NO REPORT OF ANY INSTRUMENTS THAT ENCOUNTERED THE VALVE AT THE TIME OF FRACTURE, ONLY THE HOLDER HANDLE WAS USED TO ROTATE THE VALVE. A DECISION WAS MADE EXPLANT THE DEVICE AND REPLACE IT WITH A 21MM SJM REGENT HEART VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131817 ↗
• InjurySep 19, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON 17 MAY 2022, A 23MM SJM REGENT HEART VALVE ((B)(4)) WAS IMPLANTED IN THE AORTIC VALVE AND A 31MM SJM MASTERS SERIES VALVE EXPANDED CUFF ((B)(4)) WAS IMPLANTED IN THE MITRAL VALVE DURING A DOUBLE VALVE REPLACEMENT. ON A LATER DATE, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND SYNCOPAL EPISODES. THE AORTIC VALVE AND MITRAL VALVE WERE BOTH EXPERIENCING RESISTANCE OR STICKING. ON (B)(6) 2022, ANOTHER DOUBLE VALVE REPLACEMENT WAS PERFORMED. FOR THE AORTIC VALVE, THE 23MM SJM REGENT HEART VALVE ((B)(4)) WAS EXPLANTED AND REPLACED WITH A 21MM SJM REGENT HEART VALVE ((B)(4)). FOR THE MITRAL VALVE, THE 31MM SJM MASTERS SERIES VALVE EXPANDED CUFF ((B)(4)) WAS EXPLANTED AND REPLACED WITH A 31MM SJM MASTERS SERIES VALVE EXPANDED CUFF ((B)(4)). THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Syncope/Fainting

  MAUDE report 15451409 ↗
• InjuryJul 12, 2022Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 23MM REGENT VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON AN UNKNOWN DAY IN (B)(6) 2021, THE PATIENT RETURNED WITH SYMPTOMS OF RESPIRATORY DISCOMFORT AND A FEVER. IT WAS CONFIRMED VIA ECHOCARDIOGRAM THAT THE PATIENT HAD SIGNS OF BACTERIAL INDUCED PROSTHETIC VALVE ENDOCARDITIS (PVE) AND PARAVALVULAR LEAKAGE (PVL). THE PATIENT UNDERWENT EMERGENCY SURGERY. PREOPERATIVE BLOOD CULTURES CONFIRMED PRESENCE OF STAPHYLOCOCCUS CAPITIS. THE DECISION WAS MADE TO EXPLANT THE 23MM REGENT VALVE. IT WAS NOTED DURING THE EXPLANT PROCEDURE THAT TWO-THIRDS OF THE 23MM REGENT VALVE HAD BECOME DETACHED FROM THE ANNULUS. A COMPOSITE GRAFT WAS MADE FROM A 24MM VALSALVA GRAFT AND A 21MM NON-ABBOTT DEVICE WAS IMPLANTED. THE PATIENT'S LEFT AND RIGHT CORONARY ARTERY WERE BOTH RECONSTRUCTED. NO BLEEDING WAS CONFIRMED POST-SURGERY. THE PATIENT WAS EXTUBATED ON THE 4TH POSTOPERATIVE DAY AND RECEIVED ANTIBIOTICS INTRAVENOUSLY. NO RECURRENCE OF INFECTION WAS OBSERVED DURING POSTOPERATIVE FOLLOW UP. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON 50TH POSTOPERATIVE DAY.

  Patient problems: Endocarditis

  MAUDE report 14992328 ↗
• InjuryApr 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A REGENT AORTIC VALVE ON AN UNKNOWN DATE. THE PATIENT UNDERWENT A VALVE REPLACEMENT SURGERY ON (B)(6) 2022. THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14164524 ↗
• InjuryOct 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A 23MM SJM REGENT HEART VALVE WAS SELECTED FOR AN IMPLANT ON (B)(6) 2021. ONE OF THE LEAFLET DISLODGED (AS ONE PIECE) INTO THE LEFT VENTRICLE (LV) AFTER SUTURING AND TESTING WITH THE RUBBER TESTER. THERE WAS NO RESISTANCE FELT WHEN THE PHYSICIAN ROTATED THE VALVE WITH THE VALVE ROTATOR . DEVICE WAS EXPLANTED AND WHEN THE PHYSICIAN REMOVED THE SUTURING, ANOTHER LEAFLET ALSO DISLODGED/ FALL TO THE GROUND. THERE WAS A SIGNIFICANT CLINICAL DELAYED WHICH COULD HAVE BEEN DANGEROUS TO PATIENTS LIFE. A NON ABBOTT VALVE WAS IMPLANTED AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGH THE SECOND IMPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12659086 ↗
• MalfunctionMar 31, 2021Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2648612-2021-00034. ON (B)(6) 2021, A 23MM REGENT MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. BOTH LEAFLETS OF THE VALVE BECAME DETACHED DURING TYPING OF THE VALVE SUTURES AND FELL INTO THE LEFT VENTRICLE (LV) CAVITY. THE VALVE WAS REMOVED AND BOTH LEAFLETS WERE RETRIEVED FROM THE LV; NEITHER LEAFLETS WERE REPORTED TO BE FRACTURED. A NEW 21MM REGENT MECHANICAL HEART VALVE WAS THEN IMPLANTED. AS THE PHYSICIAN WAS STARTING ANATOMY CLOSURE, ONE LEAFLET DETACHED AND FELL INTO THE LV CAVITY. THE 21MM VALVE WAS ALSO EXPLANTED AND THE LEAFLET WAS RETRIEVED FROM THE LV CAVITY; THIS LEAFLET WAS REPORTED TO HAVE BEEN FRACTURED. A NEW COMPETITOR'S ON-X WAS SUCCESSFULLY IMPLANTED. THE PHYSICIAN ALLEGED AN INCREASED PUMP TIME AND THE PATIENT WAS "CRITICAL" AFTER THE PROCEDURE. POST-OPERATIVELY, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11596135 ↗
• MalfunctionSep 18, 2020Fracture; Fracture

  ON (B)(6) 2020, A 23 MM SJM REGENT HEART VALVE WAS SELECTED FOR IMPLANT IN THE PATIENT'S AORTIC POSITION. DURING THE PROCEDURE, THE PHYSICIAN USED THE VALVE ROTATOR TO ROTATE THE VALVE, BUT ONE OF THE LEAFLETS BROKE DOWN. THE BROKEN LEAFLET AND ALL PIECES OF THE VALVE WERE EXPLANTED FROM THE PATIENT AND A 23 MM LIVANOVA TOP HAT VALVE WAS IMPLANTED INSTEAD. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE, BUT THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS CURRENTLY STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10554184 ↗