SJM Regent™ 21AGN-751Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05414734005982), received between Jun 18, 2018 and Apr 25, 2024 — classified as 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Fracture; Incomplete Coaptation; Material Split, Cut or Torn; Fracture; Incomplete Coaptation; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2024, A 21MM REGENT AORTIC VALVE WAS CHOSEN FOR IMPLANTATION. AT AN UNKNOWN POINT DURING THE PROCEDURE, THE LEAFLETS WERE NOT FUNCTIONING PROPERLY. THERE WERE NO REPORTED PATIENT EFFECTS.

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

  MAUDE report 19182472 ↗
• InjuryFeb 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 21MM SJM REGENT HEART VALVE WAS CHOSEN FOR A PROCEDURE. THE PATIENT'S INR RATIO WAS 2.0~2.5. AT THE TIME OF PREPARATION, THE LEAFLET WAS MOVING NORMALLY AND IT WAS TESTED BY A LEAFLET TESTER. DURING PROCEDURE, IT WAS NOTED THAT ONE OF THE LEAFLET WAS STACKED AND A GAP WAS OBSERVED, SO IT WAS ROTATED AND CHECKED THE LEAFLET WAS COMPLETELY CLOSED AND THE PUMP (ARTIFICIAL HEART-LUNG APPARATUS) WAS TURNED OFF, BUT THE LEAFLET WAS STACKED AGAIN, RESULTING IN SEVERE AORTIC REGURGITATION (AR). THE PUMP WAS TURNED ON AND THE VALVE WAS EXPLANTED INTERPROCEDURALLY. THE LEAFLETS ARE MOVING NORMALLY AFTER THE EXPLANT PROCEDURE. A NEW 23MM EPIC VALVE WAS IMPLANTED AS REPLACEMENT. THERE WAS SOME DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18748407 ↗
• InjuryDec 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A 21MM REGENT VALVE WAS IMPLANTED. ON (B)(6) 2023, A 21MM REGENT VALVE WAS FOUND TO HAVE A THROMBUS ON IT. IT'S UNKNOWN IF A TREATMENT WAS PERFORMANCE. PATIENT STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358260 ↗
• MalfunctionJul 17, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM REGENT VALVE WAS CHOSEN FOR PROCEDURE. THE PATIENT'S AORTIC VALVE WAS SIZED WITH A REGENT 905 SIZER SET AND BOTH 21MM AND 19MM SIZERS WERE ACCEPTABLE WITH THE PHYSICIAN OPTING FOR THE 21MM SIZE. IT WAS ALSO REPORTED THE SIZER SET WAS "TROUBLESOME" TO USE AND "DIFFICULT TO UNDERSTAND". DURING PROCEDURE, AFTER IMPLANTING THE 21MM REGENT VALVE, IT WAS NOTED THE VALVE COULD NOT OPEN OR CLOSE. A DECISION WAS MADE TO REPLACE THE VALVE WITH A 19MM REGENT VALVE. THE REPLACEMENT VALVE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. IT WAS REPORTED THERE WAS A 30MIN 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 17338079 ↗
• MalfunctionMay 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM REGENT HEART VALVE WAS CHOSEN FOR IMPLANT DURING AN AORTIC VALVE REPLACEMENT. SIZING WAS CONDUCTED USING A SJM 905 SIZER. A LARGER 21MM VALVE WAS CHOSEN DUE TO SIZING CONCERN. THE VALVE WAS ATTEMPTED TO BE IMPLANTED, BUT THE VALVE DID NOT PARACHUTE WELL INTO THE ANNULUS USING PLEDGETS. THE PATIENT HAD A HYPERTROPHIED SEPTUM AND HEAVY CALCIFICATION ON THE ANNULUS. THE POSITION OF THE SEWING CUFF WAS SUPRA-ANNULAR. THE PHYSICIAN BELIEVED THAT THE VALVE WAS UNABLE TO PARACHUTE IN WELL DUE TO SUBVALVULAR TISSUE. THE VALVE WAS REMOVED AND REPLACED WITH A 19MM SJM REGENT HEART VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974219 ↗
• MalfunctionDec 8, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM SJM REGENT HEART VALVE WAS CHOSEN FOR IMPLANT. DURING THE PROCEDURE THERE WAS AN ATTEMPT TO ROTATE THE DEVICE BUT THERE WAS RESISTANCE FELT. ROTATION WAS POSSIBLE AFTER SEWING IN THE INTRA-ANNULAR POSITION BUT WAS NOT POSSIBLE AFTER SEWING IN THE SUPRA-ANNULAR POSITION. AFTER SUTURING REGENT IN THE INTRA-ANNULAR POSITION, THE LEAFLET TOUCHED THE SUBVALVULAR TISSUE AND WAS REMOVED DUE TO POOR OPENING. THEREFORE THE LEAFLET WAS SUTURED IN THE SUPRA-ANNULAR POSITION TO PREVENT CONTACT WITH THE SUBVALVULAR TISSUE. SINCE THERE WAS STILL A PART THAT TOUCHED THE SUBVALVULAR TISSUE, THE DEVICE WAS ROTATED, BUT IT DID NOT TURN AT ALL, SO FORCE WAS APPLIED AND ONE LEAFLET CAME OFF AS IT IS. THE LEAFLET FELL OFF AS ONE INTACT PIECE AND WAS RECOVERED FROM THE PATIENT. THERE WAS AN ATTEMPT TO REINSERT THE DISLODGED LEAFLET BUT IT WAS NOT SUCCESSFUL. IT WAS NOTED THAT THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE IN ACCORDANCE WITH THE INFORMATION FOR USE. A NON-ABBOTT (18MM AP360 SERIES) DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT IS STABLE. THERE WAS NO CLINICALLY SIGNIFIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941871 ↗
• MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2022, A 21MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT IN THE AORTIC POSITION IN A PATIENT WITH A CALCIFIED AORTIC VALVE. THERE WERE NO OTHER CONCOMITANT PROCEDURES PERFORMED. THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. AFTER PLACEMENT OF SUTURES AND PARACHUTING THE VALVE, REMOVING THE HOLDER, AND TYING THE SUTURES AND TESTING WITH A SOFT TESTER, IT WAS NOTED THAT ONE LEAFLET WAS MISSING AND WAS FOUND WITHIN THE LEFT VENTRICLE. THE VALVE WAS EXPLANTED, THE MISSING LEAFLET WAS RETRIEVED FROM THE LEFT VENTRICLE, AND A NEW 19MM REGENT AORTIC MECHANICAL HEART VALVE WAS IMPLANTED. A 21MM REGENT VALVE COULD NOT BE IMPLANTED BECAUSE THERE WAS NO INVENTORY AVAILABLE WITH THE 21MM VALVE SIZE. THE PATIENT HAD NO COMPLICATIONS AND WAS EXTUBATED POST-IMPLANT WITH NO NEUROLOGIC ADVERSE EVENT. UPON INSPECTION OF THE 21MM VALVE, THERE WAS NO OBVIOUS DAMAGE TO THE VALVE CARBON HOUSING OR THE INDIVIDUAL LEAFLETS. THE SECOND LEAFLET FELL OUT OF THE VALVE HOUSING SPONTANEOUSLY WITHOUT ANY MANIPULATION AFTER THE VALVE WAS EXPLANTED. ADDITIONALLY, POST-IMPLANT THE SURGEON ATTEMPTED TO GENTLY INSERT AND FIX ONE OF THE LEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736641 ↗
• MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE LEAFLET OF THE 21MM SJM REGENT HEART VALVE HAD DISLODGED WHEN BEING POSITIONED DOWN INTO THE PATIENT'S ANNULUS. IT WAS NOTED THAT THE LEAFLET HAD DISLODGED AS AN ENTIRE PIECE. THE DISLODGED LEAFLET IS CONFIRMED TO HAVE BEEN REMOVED FROM THE PATIENT. THERE WAS NO NOTED DIFFICULTY OR RESISTANCE ROTATING THE VALVE. NO INSTRUMENTS ENCOUNTERED THE VALVE AT THE TIME OF DISLODGMENT AND THERE WAS NO ATTEMPT MADE TO REINSERT THE DISLODGED LEAFLET. THERE WAS NOTHING ELSE OTHER THAN THE HOLDER HANDLE USED TO POSITION OR ROTATE THE VALVE. THE 21MM SJM REGENT HEART VALVE WAS NOTED AS BEING IN THE FULLY CLOSED POSITION WHEN BEING LOWERED INTO THE PATIENT'S ANNULUS. A CORRECTION NEEDS TO BE MADE THAT A 19MM SJM REGENT HEART VALVE WAS IMPLANTED AS A REPLACEMENT DEVICE, NOT A 17MM SJM REGENT HEART VALVE AS PREVIOUSLY MENTIONED. IT WAS NOTED THAT DUE TO THE UNAVAILABILITY OF A ANOTHER 21MM SJM REGENT HEART VALVE, A 19MM SJM REGENT HEART VALVE WAS SELECTED AS A REPLACEMENT DEVICE. THE 19MM SJM REGENT HEART VALVE WAS DEEMED SUITABLE FOR IMPLANT IN THE PRESENCE OF ANOTHER 21MM SJM REGENT HEART VALVE

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

  MAUDE report 15581919 ↗
• InjurySep 14, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022 A 21MM REGENT MECHANICAL HEART VALVE WAS IMPLANTED SUCCESSFULLY. ON (B)(6) 2022, THE VALVE WAS EXPLANTED DUE TO LACK OF MOBILITY OF ONE OF THE VALVE LEAFLETS THAT WAS CONFIRMED ON AORTOGRAPHY. THERE WAS SEVERE AORTIC INSUFFICIENCY WITH CIRCULATORY COLLAPSE. A NON-ABBOTT DEVICE WAS SUCCESSFULLY IMPLANTED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME OF REPORT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15420299 ↗
• InjuryApr 11, 2022Fracture; Incomplete Coaptation; Physical Resistance/Sticking; Fracture; Incomplete Coaptation; Physical Resistance/Sticking

  IT WAS REPORTED ON (B)(6) 2022, A 21MM REGENT MECHANICAL HEART VALVE WAS IMPLANTED IN THE AORTIC POSITION DUE TO ASCENDING AORTA ANEURYSM AND AORTIC VALVE DISEASE. DURING IMPLANT, IT WAS NOTED THAT ONE OF LEAFLET'S MOTION WAS RESTRICTED. THE PHYSICIAN USED THE HOLDER HANDLE TO ATTEMPT TO ROTATE THE VALVE BUT IT WAS NOT POSSIBLE. THE SURROUNDING AREA OF THE VALVE WAS CHECKED FOR ANY INTERFERING TISSUE, BUT INTERFERENCES WERE REPORTED. THE PROCEDURE WAS COMPLETED. AFTER IMPLANTATION, ONE OF THE LEAFLETS WAS WORKING PERFECTLY BUT THE OTHER ONE WAS NOT MOVING FREELY. BECAUSE THERE WAS NO INTERFERENCE NOTED, THE PHYSICIAN THOUGHT THAT THE LEAFLET WOULD ACHIEVE FREE MOVEMENT WITH THE NATURAL HEART MOVEMENT. IMMEDIATELY POST PROCEDURE, A CENTRAL ECHOCARDIOGRAM (ECHO) WAS PERFORMED AND INCREASED GRADIENT WAS NOTED. AN ANGIOGRAPHY WAS PERFORMED, AND IT WAS NOTED THAT ONE LEAFLET WAS NOT MOVING FREELY. IT WAS DECIDED TO EXPLANT THE VALVE. DURING EXPLANT PROCEDURE ON (B)(6) 2022, IT WAS NOTED AGAIN THAT THE LEAFLET WAS STILL NOT MOVING. UPON EXPLANT EXAMINATION THE LEAFLET BROKE. A NEW 23MM MASTERS MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. PATIENT WAS REPORTED TO BE IN STABLE CONDITI

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 14073809 ↗
• MalfunctionMar 31, 2021Fracture; Material Separation; Fracture; Material Separation

  RELATED MANUFACTURER REFERENCE NUMBER: 2648612-2021-00033. 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 11596119 ↗
• InjuryOct 24, 2019Fracture; Fracture

  ON (B)(6) 2019, A 21MM REGENT VALVE WAS SELECTED FOR IMPLANT. THE VALVE LEAFLET DISLOCATED WHEN SUTURING. THE VALVE WAS IMMEDIATELY EXPLANTED AND THE PATIENT WAS IMPLANTED WITH A COMPETITOR'S MEDTRONIC AP360 VALVE. ALL PIECES OF THE DEVICE WAS CONFIRMED TO BE REMOVED. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE USER DOES ALLEGE A CLINICALLY SIGNIFICANT PROLONGED PROCEDURE TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9233141 ↗
• MalfunctionJul 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2019, A 21 MM REGENT HEART VALVE WAS IMPLANTED. POST IMPLANT, THE LEAFLETS WERE OBSERVED TO BE IMMOBILE. THE SITE ATTEMPTED TO RE-POSITION THE VALVE, DURING WHICH ONE OF THE VALVE LEAFLETS DETACHED. THE VALVE WAS REMOVED AND REPLACED WITH A 19 MM MECHANICAL HEART VALVE (MODEL: UNKNOWN). THE SITE ATTEMPTED TO RE-POSITION THE LEAFLETS, BUT WERE UNABLE TO ROTATE THE DEVICE. A POST-SURGERY ECO SHOWED THAT THE VALVE WAS WORKING NORMALLY. THE PATIENT EXPIRED 48 HOURS POST PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Death

  MAUDE report 8828688 ↗
• InjuryApr 29, 2019Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2019, A 21MM REGENT VALVE WAS IMPLANTED. ON (B)(6) 2019, ECHO INDICATED LEAFLET OBSTRUCTION ACCOMPANIED BY MODERATELY HIGH GRADIENT (MEAN = 28MMHG, PEAK = 48MM HG) AND MODERATE REGURGITATION. ACCELERATION TIME WAS 111MS, AND AORTIC REGURGITATION PRESSURE HALF TIME WAS 347MS. ON (B)(6) 2019, THE REGENT VALVE WAS EXPLANTED, AND A REPLACEMENT 21MM REGENT VALVE WAS IMPLANTED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. UPON EXPLANT, NO OBVIOUS THROMBUS OR TISSUE GROWTH ON THE VALVE WAS OBSERVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Aortic Regurgitation

  MAUDE report 8562056 ↗
• InjuryJul 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, A 21MM REGENT HEART VALVE WAS CHOSEN FOR IMPLANT. AFTER THE PHYSICIAN PLACED THE SUTURES ON THE VALVE, THE LEAFLET DISLODGED FROM THE VALVE WITHOUT ANY FORCE. THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER 21MM REGENT HEART VALVE TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE STABLE. ALTHOUGH NO PATIENT CONSEQUENCES WERE REPORTED, THE PROCEDURE TIME WAS EXTENDED BY 30 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7662762 ↗
• InjuryJun 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, A 21MM REGENT VALVE WAS IMPLANTED. DURING IMPLANT, ONE OF THE LEAFLETS DISLODGED INTACT INTO THE LEFT VENTRICLE. THE DEVICE AND ENTIRE DISLODGED LEAFLET WERE REMOVED FROM THE PATIENT, AND ANOTHER 21MM REGENT VALVE ((B)(4)) WAS IMPLANTED. THE PROCEDURE WAS EXTENDED BY 45 MINUTES AND THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7642181 ↗
• InjuryJun 18, 2018Gradient Increase; Obstruction of Flow; Gradient Increase; Obstruction of Flow

  ON (B)(6) 2011, A 21MM REGENT HEART VALVE WAS IMPLANTED. THE PATIENT PRESENTED WITH A HIGH PRESSURE GRADIENT AND ONE OF THE LEAFLETS HAD RESTRICTIVE MOTION AND WAS NOT OPENING. PER REPORT THE PATIENT HAD BEEN ON ANTICOAGULATION AND WAS COMPLIANT. ON (B)(6) 2018, THE VALVE WAS EXPLANTED AND ANOTHER 21MM REGENT HEART VALVE WAS IMPLANTED AS THE REPLACEMENT. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Aortic Insufficiency

  MAUDE report 7611853 ↗