RegentRecalls & reported problems across all models
St. Jude Medical, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 111
- Deaths reported
- 5
- Injuries reported
- 24
- Recalls
- 0
We found 6 models of Regent by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 111 adverse event reports in the FDA's MAUDE database, received between May 10, 2024 and Sep 25, 2026 — classified as 5 deaths, 24 injuries, 82 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (48 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
Reports received per month, all models
Most reported Regent problems
Device problems
- Physical Resistance/Sticking48
- Incomplete Coaptation21
- Detachment of Device or Device Component18
- Fracture12
- Patient Device Interaction Problem7
- Material Split, Cut or Torn6
- Perivalvular Leak5
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions93
- Insufficient Information8
- Aortic Valve Insufficiency/ Regurgitation5
- Aortic Valve Stenosis3
- Angina1
- Arrhythmia1
- Coronary obstruction/occlusion1
- Dyspnea1
Regent models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Regent™ 21AGFN-756HEART-VALVE, MECHANICAL3 deaths35 reports
- Regent™ 23AGFN-756HEART-VALVE, MECHANICAL2 deaths33 reports
- Regent™ 19AGFN-756HEART-VALVE, MECHANICAL31 reports
- Regent™ 21AGN-751HEART-VALVE, MECHANICAL8 reports
- Regent™ 23AGN-751HEART-VALVE, MECHANICAL3 reports
- Regent™ 25AGN-751HEART-VALVE, MECHANICAL1 report
Recent Regent adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Detachment of Device or Device Component
It was reported that on (b)(6) 2026, a 21mm SJM Regent Heart Valve was chosen for a procedure. During procedure, the leaflet got broken into one piece and the dislodged piece was recovered from the patient. A new replacement device was implanted. There was no delay in the procedure. The patient was reported recovering.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898059 ↗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 ↗MalfunctionSep 18, 2026Incomplete Coaptation
It was reported that on (b)(6) 2026, a 19mm SJM Regent Heart Valve w/Flex Cuff was chosen for a procedure. During the operation, it was noted that the valve leaflets were stuck. The valve got removed and an Unknown size Mechanical Heart Valve 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 50817176 ↗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 ↗MalfunctionAug 7, 2026Material Split, Cut or Torn
It was reported that on(b)(6) 2026, a 25mm SJM Regent Heart Valve was chosen for a procedure. After implantation, an increased pressure gradient was noted. A tear in the valve ring was confirmed by visual observation. The valve got explanted and a 23mm SJM Regent Heart Valve was implanted. The patient was reported stable.
Patient problems: Aortic Valve Stenosis
MAUDE report 50176642 ↗MalfunctionJul 8, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT ON (B)(6) 2026, A 21MM SJM REGENT HEART VALVE WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. AFTER IMPLANTATION SURGEON FOUND THAT VALVE IS NOT ROTATING. THE VALVE GOT EXPLANTED AND IMPLANTED A NEW 19MM SJM REGENT HEART VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25753555 ↗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 ↗MalfunctionJun 25, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING IMPLANT, THE PHYSICIAN ROTATED THE VALVE WITH THE VALVE ROTATOR; NO RESISTANCE WAS FELT WHEN ROTATING. THEN, A LEAFLET DISLODGED IN ONE PIECE AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO INSTRUMENT WAS IN CONTACT WITH THE VALVE AT TIME OF DISLODGEMENT. THE PHYSICIAN DID NOT ATTEMPT TO REINSERT THE DISLODGED LEAFLET. THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE AND THE VALVE WAS IN A CLOSED POSITION WHEN IT WAS ROTATED. THE DEVICE WAS NOT IMPLANTED AND EXCHANGED FOR A NEW 19MM REGENT AORTIC MECHANICAL HEART VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN NORMAL CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627035 ↗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 15, 2026Incomplete Coaptation
IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS CHOSEN FOR A AORTIC VALVE MECHANICAL VALVE REPLACEMENT SURGERY. THE LEAFLET FUNCTION WAS TESTED USING A SILICONE PRODUCTS, DURING THE SURGERY, AFTER THE IMPLANTED MECHANICAL VALVE ENABLED THE HEART TO RESUME BEATING AGAIN ON ESOPHAGEAL ULTRASOUND EXAMINATION, IT WAS FOUND THAT THE TRANS-VALVE PRESSURE DIFFERENCE WAS TOO HIGH AND THE BLOOD FLOW RATE WAS TOO FAST. LATER, TESTS REVEALED THAT IT WAS DIFFICULT TO OPEN AND CLOSE THE VALVE LEAFLETS. DUE TO INSUFFICIENT STOCK AT THE HOSPITAL, A NEW 17MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS RE-IMPLANTED FOR THE ESOPHAGEAL ULTRASOUND WHILE PATIENT ON BYPASS. AT THIS TIME, THE TRANS-VALVE PRESSURE DIFFERENCE AND FLOW RATE WERE NORMAL. THERE WAS NO DELAY IN THE PROCEDURE AND PATIENT WAS REPORTED DISCHARGED FROM HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25184048 ↗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 ↗MalfunctionMay 11, 2026Fracture; Physical Resistance/Sticking
IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. AFTER IMPLANTATION, NO ROTATION WAS OBSERVED BUT UPON REMOVAL OF THE MAIN BODY, A VALVE LEAFLET WAS FRACTURED INTO MULTIPLE PIECES AND DISLODGED. ALL PIECES WERE COMPLETELY REMOVED FROM THE PATIENT. WHILE ROTATING A RESISTANCE WAS ENCOUNTERED AND IT REPORTEDLY DID NOT MOVE AT ALL. A NEW 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE PATIENT ON BYPASS. THE PATIENT WAS REPORTED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25143377 ↗
Other St. Jude Medical, Inc. products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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