SJM RegentRecalls & reported problems across all models

We found 9 models of SJM Regent by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 253 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2018 and Apr 7, 2026 — classified as 16 deaths, 120 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (76 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SJM Regent problems

SJM Regent models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SJM Regent™ AGFN-756

  HEART-VALVE, MECHANICAL
  3 deaths70 reports
• SJM Regent™ AGFN-756

  HEART-VALVE, MECHANICAL
  5 deaths66 reports
• SJM Regent™ 23AGFN-756

  HEART-VALVE, MECHANICAL
  3 deaths44 reports
• SJM Regent™ 25AGFN-756

  HEART-VALVE, MECHANICAL
  2 deaths23 reports
• SJM Regent™ 19AGN-751

  HEART-VALVE, MECHANICAL
  3 deaths22 reports
• SJM Regent™ 21AGN-751

  HEART-VALVE, MECHANICAL
  17 reports
• SJM Regent™ 23AGN-751

  HEART-VALVE, MECHANICAL
  9 reports
• SJM Regent™ 25AGN-751

  HEART-VALVE, MECHANICAL
  1 report
• SJM Regent™ 27AGN-751

  HEART-VALVE, MECHANICAL
  1 report

Recent SJM Regent adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM SJM REGENT HEART VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE LEAFLET CAME OUT AND WENT LEFT VENTRICLE. THEY CONFIRMED THE INTACT LEAFLET WAS RECOVERED FROM THE PATIENT. THE VALVE GOT REMOVED AND REPLACED WITH ANOTHER VALVE WHILE PATIENT ON BYPASS. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808722 ↗
• 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 ↗
• MalfunctionFeb 9, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, 19MM SJM REGENT HEART VALVE WAS CHOSEN TO REPLACE A DEGENERATED NATIVE AORTIC VALVE. DURING THE PROCEDURE, IT WAS NOTED THAT ONE OF THE LEAFLETS OF THE MECHANICAL REGENT VALVE PROLAPSED. THIS OCCURRED IMMEDIATELY AFTER THE VALVE IMPLANTATION BEGAN, WITHOUT PRIOR ATTEMPTS TO ROTATE THE VALVE OR MECHANICALLY POSITION IT. A NEW 19MM VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE AND PATIENT WAS REPORTED DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298416 ↗
• 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 ↗
• MalfunctionSep 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073881 ↗
• MalfunctionJul 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM REGENT HEART VALVE WAS SELECTED FOR IMPLANT IN A PATIENT. IT WAS NOTED DURING PROCEDURE THAT THE SUTURE CUFF OF THE VALVE WAS TORN WHEN THE NEEDLE AND THREAD WERE APPLIED AND WAS THEREFORE NOT IMPLANTED. THE VALVE WAS REMOVED AND NOT HANDLED WITH ANY UNPROTECTED FORCEPS OR SHARP INSTRUMENTS. THE VALVE HOLDER WAS NOT REMOVED AND WAS USED TO PARACHUTE THE VALVE INTO THE ANNULUS. A COR-KNOT DEVICE WAS NOT USED DURING THE PROCEDURE. THE DECISION WAS MADE TO REPLACE 19MM REGENT HEART VALVE WITH A 17MM REGENT HEART VALVE TO COMPLETE THE PROCEDURE. THE PATIENT HAD NO CLINICAL SIGNS OR SYMPTOMS ASSOCIATED WITH THIS EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONALLY, THE PATIENT WAS NOT TAKEN OFF BYPASS AND PLACED BACK ON BYPASS AT ANY POINT DUE TO THIS EVENT. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639361 ↗
• MalfunctionJul 14, 2025Fracture; Fracture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501503 ↗
• MalfunctionJul 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. THE NATIVE AORTIC VALVE WAS SIZED WITH A 19MM REGENT AGN SIZER. DURING DEVICE PREPARATION, THE LEAFLETS WERE TESTED AND MOVING NORMALLY WHEN TESTED WITH A LEAFLET TESTER. THE REGENT AORTIC VALVE WAS THEN IMPLANTED. HOWEVER, POST-IMPLANT, IT WAS OBSERVED THAT THE LEAFLET DID NOT OPEN. SUBSEQUENTLY, THE VALVE WAS REMOVED. OUTSIDE OF THE PATIENT, THE LEAFLETS WERE TESTED AGAIN AND OPENED WITH NO ISSUE. A NEW 17MM REGENT AORTIC MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. OF NOTE, PRIOR TO THE REGENT PROCEDURE, A 25MM MASTERS MITRAL MECHANICAL HEART VALVE WAS IMPLANTED TO TREAT SEVERE MITRAL REGURGITATION; NO IMPLANT COMPLICATIONS WERE REPORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387119 ↗
• DeathJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. AFTER THE VALVE WAS PARACHUTED DOWN, THE HANDLE WAS REMOVED AND THE SUTURES WERE TIED. THE VALVE WAS NOT ATTEMPTED TO BE ROTATED. PRIOR TO PATIENT CLOSURE, THE VALVE LEAFLETS WERE INTENDED TO BE TESTED FOR MOBILITY. HOWEVER, IT WAS DISCOVERED THAT ONE OF THE LEAFLETS WAS MISSING. THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT 90 DEGREES. THE LEAFLET HAD DISLODGED IN ONE PIECE AND WAS RECOVERED FROM THE PATIENT. THE VALVE WAS EXPLANTED AND A NEW 21MM REGENT AORTIC MECHANICAL HEART VALVE WAS IMPLANTED AS THE SAME SIZE WAS NOT AVAILABLE. POST-OPERATIVELY, THE PATIENT REMAINED ON VENTILATOR SUPPORT. ON (B)(6) 2024, THE PATIENT STOPPED MAKING URINE AND WAS NOT HOLDING BLOOD PRESSURE. THEREFORE, INTRA-AORTIC BALLOON WAS INSERTED TO AUGMENT THE BLOOD PRESSURE. ON (B)(6) 2024, THE PATIENT WAS REPORTED TO HAVE PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS UNKNOWN. THE 21MM REGENT VALVE REMAINS IMPLANTED IN THE PATIENT. HOWEVER, THE PATIENT ALLEGED THAT THE 19MM VALVE CONTRIBUTED TO THE PATIENT PASSING AND THAT THE 21MM REGENT VALVE DID NOT CONTRIBUTE TO THE PATIENT PASSING.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 21093909 ↗
• 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 ↗
• InjurySep 16, 2024Incomplete Coaptation; Incomplete Coaptation

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224212 ↗
• 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 ↗

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