Masters SeriesRecalls & reported problems across all models
St. Jude Medical, Inc. · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 71
- Deaths reported
- 5
- Injuries reported
- 21
- Recalls
- 0
We found 28 models of Masters Series by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Jul 6, 2023 and Sep 21, 2026 — classified as 5 deaths, 21 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (23 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 Masters Series problems
Device problems
- Physical Resistance/Sticking23
- Fracture15
- Incomplete Coaptation14
- Detachment of Device or Device Component9
- Contamination /Decontamination Problem5
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information4
- Patient Device Interaction Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- Insufficient Information7
- Heart Failure/Congestive Heart Failure5
- Aortic Valve Stenosis3
- Myocardial Infarction3
- Shock3
- Thrombosis/Thrombus3
- Unspecified Infection3
Masters Series models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Masters Series™ 27MJ-501HEART-VALVE, MECHANICAL1 death13 reports
- Masters Series™ 29MJ-501HEART-VALVE, MECHANICAL2 deaths9 reports
- Masters Series™ 31MJ-501HEART-VALVE, MECHANICAL6 reports
- Masters Series™ 21AHPJ-505HEART-VALVE, MECHANICAL5 reports
- Masters Series™ 25AJ-501HEART-VALVE, MECHANICAL3 reports
- Masters Series™ 23CAVGJ-514 00HEART-VALVE, MECHANICAL3 reports
- Masters Series™ 25CAVGJ-514 00HEART-VALVE, MECHANICAL3 reports
- Masters Series™ 27MECJ-502HEART-VALVE, MECHANICAL3 reports
- Masters Series™ 33MECJ-502HEART-VALVE, MECHANICAL3 reports
- Masters Series™ 23AJ-501HEART-VALVE, MECHANICAL2 reports
- Masters Series™ 27AJ-501HEART-VALVE, MECHANICAL2 reports
- Masters Series™ 19AHPJ-505HEART-VALVE, MECHANICAL1 death2 reports
- Masters Series™ 25MJ-501HEART-VALVE, MECHANICAL2 reports
- Masters Series™ 15AHPJ-505HEART-VALVE, MECHANICAL1 report
- Masters Series™ 21AJ-501HEART-VALVE, MECHANICAL1 report
- Masters Series™ 31AJ-501HEART-VALVE, MECHANICAL1 report
- Masters Series™ 25AHPJ-505HEART-VALVE, MECHANICAL1 report
- Masters Series™ 27AHPJ-505HEART-VALVE, MECHANICAL1 report
- Masters Series™ 17MHPJ-505HEART-VALVE, MECHANICAL1 report
- Masters Series™ 33CAVGJ-514 00HEART-VALVE, MECHANICAL1 report
- Masters Series™ 19MHPJ-505HEART-VALVE, MECHANICAL1 report
- Masters Series™ 21MHPJ-505HEART-VALVE, MECHANICAL1 report
- Masters Series™ 25MHPJ-505HEART-VALVE, MECHANICAL1 report
- Masters Series™ 27MHPJ-505HEART-VALVE, MECHANICAL1 report
- Masters Series™ 19CAVGJ-514 00HEART-VALVE, MECHANICAL1 death1 report
- Masters Series™ 21CAVGJ-514 00HEART-VALVE, MECHANICAL1 report
- Masters Series™ 27CAVGJ-514 00HEART-VALVE, MECHANICAL1 report
- Masters Series™ 29MECJ-502HEART-VALVE, MECHANICAL1 report
Recent Masters Series adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Incomplete Coaptation
It was reported that on (b)(6) 2026, a 25mm SJM Masters Series Hemodynamic Plus Valve was chosen for a procedure. During procedure, an inability of the valve to open was noted after weaning from cardiopulmonary bypass, during intraoperative transesophageal echocardiogram (TEE) assessment. The patient was placed back on cardiopulmonary bypass for explanation of the valve and implantation of the biological valve. The patient need for repeat cardiopulmonary bypass and valve replacement resulted in prolonged cardiopulmonary bypass and myocardial ischemic times. The patient was reported stable.
Patient problems: Myocardial Infarction
MAUDE report 50845798 ↗MalfunctionAug 7, 2026Fracture; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50176848 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
It was reported that on (b)(6) 2021, a 15mm Masters Series Hemodynamic Plus Aortic Valve was chosen for implant. It was then reported on (b)(6) 2026, patient was hospitalized and underwent an unknown procedure. It was not confirmed if the 15mm Masters aortic valve was explanted or replaced.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50018802 ↗MalfunctionJul 17, 2026Fracture; Physical Resistance/Sticking
It was reported that on (b)(6) 2026, a 27mm SJM Masters Series Valve Expanded Cuff was chosen for a procedure. While rotating the valve a moderate resistance was felt. During the procedure, after the valve implant when they rotated the valve both leaflets popped out. They confirmed both leaflets were recovered. They explanted it and replaced with a new 27mm SJM Masters Series Valve Expanded Cuff. There was some delay occurred from excising first valve and placing second valve. The patient was reported in post operative recovery course.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25855383 ↗InjuryJul 13, 2026Insufficient Device Problem Information; Patient Device Interaction Problem
IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2026, A DIZZINESS WAS OBSERVED IN THE PATIENT PRIOR TO RESECTION. A MASS-LIKE ATTACHMENT WAS FOUND ON THE VALVE. THE VALVE GOT EXPLANTED AND A NEW 27MM EPIC PLUS MITRAL VALVE WAS IMPLANTED. THE EXPLANTED VALVE HAD A SLIGHT PANNUS-LIKE STRUCTURE WAS ATTACHED TO THE COMMISSURAL AREA. THERE WAS NO TEAR WAS OBSERVED IN THE LEAFLETS AND SUTURE CUFF. THE PATIENT WAS REPORTED STABLE AND HOSPITALIZED.
Patient problems: Insufficient Information; Movement Disorder; Thrombosis/Thrombus
MAUDE report 25802999 ↗DeathJun 5, 2026Fracture; Improper or Incorrect Procedure or Method; Incomplete Coaptation; Physical Resistance/Sticking
IT WAS REPORTED ON (B)(6) 2026 A 29MM MASTERS MITRAL VALVE WAS SELECTED FOR IMPLANT FOR MITRAL VALVE REPLACEMENT. THE PATIENT'S POSTERIOR WALL WAS NOTED TO BE SEVERELY CALCIFIED, WHICH FIRST REQUIRED A CALCIFICATION RESECTION. THE VALVE WAS IMPLANTED. ON POSTOPERATIVE DAY 2, LEAFLET MOTION RESTRICTION WAS NOTED DURING ECHOCARDIOGRAPHY, AND THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE. THE POSTERIOR WALL WAS DECALCIFIED SEVERAL TIMES. THE DEVICE REMAINED STABLE. A SECOND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) LEAFLET MOTION RESTRICTION WAS OBSERVED AGAIN, AND THE DEVICE WAS NOT ROTATED. THE DECISION WAS MADE TO EXPLANT THE DEVICE. WHILST REMOVING THE DEVICE, THE DEVICE WAS DAMAGED. A NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS STABLE WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) IN THE INTENSIVE CARE UNIT (ICU). FIVE DAYS LATER THE PATIENT PASSED AWAY. THE PHYSICIAN BELIEVED THE ISSUE WAS RELATED WITH THE HEAVY CALCIFICATION ON THE MITRAL VALVE AND POSTERIOR WALL.
Patient problems: Insufficient Information; Shock
MAUDE report 25415266 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT CARDIAC SURGERY ON (B)(6) 2025, INCLUDING SEPTAL MYOMECTOMY AND AN ATTEMPTED MITRAL VALVE REPAIR WITH AN ANNULOPLASTY RING. DUE TO INTRAOPERATIVE FAILURE OF THE REPAIR, THE PROCEDURE WAS CONVERTED TO MITRAL VALVE REPLACEMENT WITH IMPLANTATION OF A MASTER SERIES MECHANICAL HEART VALVE (ABBOTT / (B)(6) . THE SURGICAL COURSE WAS CHARACTERIZED BY PROLONGED AND CUMULATIVE AORTIC CROSS-CLAMP TIME OF APPROXIMATELY 206 MINUTES, RESULTING FROM AN EXTENDED INITIAL REPAIR ATTEMPT FOLLOWED BY RE-CLAMPING FOR VALVE REPLACEMENT. POSTOPERATIVELY, THE PATIENT DEVELOPED SEVERE HEMODYNAMIC INSTABILITY AND CARDIOGENIC SHOCK, WITH BIOLOGICAL MARKERS DEMONSTRATING EXTENSIVE MYOCARDIAL INJURY (MARKEDLY ELEVATED TROPONIN, CK/CK-MB, AND BNP VALUES), CONSISTENT WITH A MAJOR PERIOPERATIVE MYOCARDIAL INFARCTION. THE CLINICAL EVOLUTION WAS FURTHER COMPLICATED BY ACUTE HEART FAILURE REQUIRING PROLONGED HIGH-DOSE INOTROPIC AND VASOPRESSOR SUPPORT, RESPIRATORY FAILURE, SEPTIC SHOCK, AND MULTIORGAN DYSFUNCTION. THE PATIENT REQUIRED MULTIPLE SURGICAL REINTERVENTIONS, RENAL REPLACEMENT THERAPY, PROLONGED MECHANICAL VENTILATION WITH TRACHEOSTOMY, GASTROSTOMY, AND EXTENDED INTENSIVE CARE AND HOS
Patient problems: Heart Failure/Congestive Heart Failure; Ischemia; Low Blood Pressure/ Hypotension; Myocardial Infarction; Obstruction/Occlusion; Renal Failure; Respiratory Insufficiency; Sepsis; Shock; Unspecified Infection
MAUDE report 25237019 ↗DeathMay 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON 07 APR 2026, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOE A DOUBLE VALVE REPLACEMENT (DVR) PROCEDURE. THE VALVE WAS IMPLANTED AT MITRAL POSITION. AFTER SURGERY PATIENT GOT COLLAPSED AND THE REASON WAS UNKNOWN.
Patient problems: Cardiac Arrest; Insufficient Information
MAUDE report 25056575 ↗MalfunctionApr 29, 2026Incomplete Coaptation
IT WAS REPORTED THAT ON (B)(6) 2026, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR A MITRAL VALVE REPLACEMENT (MVR) PROCEDURE. THE LEAFLET FUNCTION WAS TESTED USING A LEAFLET TESTER. DURING PROCEDURE, THE PHYSICIAN FOUND THAT ONE LEAFLET WAS NOT OPENING PROPERLY. ULTIMATELY, THEY HAD TO EXPLANT THE VALVE AND IMPLANTED COMPETITION VALVE OF SAME SIZE WHILE PATIENT ON BYPASS. THE PATIENT WAS REPORTED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035429 ↗MalfunctionApr 17, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT ON (B)(6) 2026, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, AFTER SIZING WITH 27 SIZE REPLICA END WITH MHV 905 SIZER IT WAS GOING WELL BUT AFTER SUTURE, WHILE PARACHUTING THE VALVE WAS NOT FITTING WELL. A NEW 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912663 ↗MalfunctionApr 10, 2026Incomplete Coaptation
IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT SURGERY. THE LEAFLET FUNCTION WAS TESTED USING A MECHANICAL HEART VALVE LEAFLET TESTER (LT100). 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 VALVE WAS REMOVED AND REPLACED BY ANOTHER 25MM SJM MASTERS SERIES MECHANICAL HEART VALVE WHILE PATIENT ON BYPASS. THE OPERATION WAS FINALLY COMPLETED, AND THE PATIENT WAS IN STABLE CONDITION. THERE WAS PROLONGED THE DURATION OF CARDIOPULMONARY BYPASS OCCLUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845660 ↗MalfunctionApr 10, 2026Fracture
IT WAS REPORTED THAT ON (B)(6) 2026, A 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN TO ADDRESS MITRAL VALVULOPLASTY. DURING PROCEDURE, ONCE THE PROSTHETIC DEVICE HAD BEEN IMPLANTED, AN ATTEMPT WAS MADE TO ROTATE THE VALVE TO FACILITATE THE OPENING OF BOTH LEAFLETS; HOWEVER, ONE OF THE LEAFLETS FRACTURED. CONSEQUENTLY, THE DECISION WAS MADE TO EXPLANT THE DEVICE AND IMPLANT A NEW 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839604 ↗InjuryMar 30, 2026Fracture; Incomplete Coaptation
IT WAS REPORTED THAT ON (b)(6 )2026, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR A PROCEDURE. AFTER THE VALVE SUTURE WAS COMPLETED, INTRAOPERATIVE COLOR DOPPLER ULTRASOUND REVEALED POOR LEAFLET MOBILITY. WHEN THE CHEST WAS REOPENED, IT WAS FOUND THAT THERE WERE LEAFLET FRAGMENTS THAT HAD FALLEN OFF AND WERE FLOATING IN THE ARTERIAL VESSELS. THE SURGEON KEPT SEARCHING FOR THEM, WHICH LED TO A DELAY OF MORE THAN 10 HOURS IN THE OPERATION TIME AND ALSO ADDED MANY COMPLEX STEPS TO THE SURGICAL PROCEDURE. A NEW 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT IS CURRENTLY IN THE INTENSIVE CARE UNIT AND REPORTED RECOVERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24717963 ↗MalfunctionMar 30, 2026Fracture
IT WAS REPORTED THAT ON (B)(6) 2026, A 27MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE VALVE FELL APART BEFORE BEING IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24717953 ↗MalfunctionFeb 20, 2026Incomplete Coaptation
IT WAS REPORTED THAT ON 27 JAN 2026, A 21MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR A PROCEDURE. THE LEAFLET FUNCTION WAS TESTED WITH A PLASTIC HOSE. DURING THE OPERATION, THE VALVE LEAFLETS WERE STUCK. AN UNKNOWN SIZE MECHANICAL HEART VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE 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 24401860 ↗
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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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