Masters Series™ 27MJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05415067045034), received between Aug 15, 2024 and Aug 7, 2026 — classified as 1 death, 1 injury, 11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Fracture; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176848 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 30, 2025Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR A MITRAL VALVE REPAIR (MVR) PROCEDURE. DURING IMPLANTATION AFTER SIZING THE VALVE, THERE WAS SOME RESISTANCE FELT WHEN ROTATING. AFTER IMPLANT, THE SURGEON FOUND THAT VALVE LEAFLET WAS DISLODGED INTO ONE PIECE. THE DISLODGED PIECE WAS RECOVERED FROM PATIENT. THE VALVE WAS EXPLANTED AND A NEW 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926621 ↗
• MalfunctionAug 8, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749572 ↗
• MalfunctionJul 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR A PROCEDURE. AFTER SUTURE TYING, THE VALVE WAS BROKEN FROM ITS HINGE WHILE DOING LAST MANIPULATION WITH HOLDER FOR SITTING THE VALVE. THE VALVE BROKEN FROM ITS HINGE WAS RECOVERED FROM THE PATIENT. A NEW 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22485002 ↗
• MalfunctionApr 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM MASTERS VALVE WAS SELECTED FOR IMPLANT. THERE WERE NO ISSUES NOTED DURING PREP. ONCE THE VALVE WAS IMPLANTED, IT WAS NOTED THAT THERE WAS POOR OPENING AND CLOSING OF THE VALVE LEAFLETS. THE DEVICE WAS REMOVED AND REPLACED WITH A NON-ABBOTT VALVE TO RESOLVE THE EVENT. THE PATIENT WAS NEVER TAKEN OFF OF BYPASS. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858467 ↗
• MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON 24 FEBRUARY 2025, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE CHIEF SURGEON USED STANDARDIZED VALVE MEASUREMENT METHODS TO MEASURE THE SIZE OF THE VALVE ANNULUS DURING LAPAROSCOPIC MITRAL VALVE REPLACEMENT SURGERY. THE SURGEON EXPERIENCED LEAFLET DETACHMENT WHILE ROTATING THE VALVE LEAFLETS TO CHECK THEIR OPENING AND CLOSING STATUS AFTER SUTURING THE VALVE. THE LEAFLET WAS DISLODGED INTO ONE PIECE AND THEY CONFIRMED THE INTACT LEAFLET WAS RECOVERED FROM THE PATIENT. IN THE END, THE CHIEF SURGEON REPLACED THE VALVE WITH A NEW 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE. THERE WAS NO LEAFLET DETACHMENT OCCURRED WHEN ROTATING THE VALVE LEAFLETS, AND THE SURGERY WAS VERY SUCCESSFUL. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21703037 ↗
• MalfunctionFeb 11, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM MASTERS MITRAL MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING PROCEDURE, ECHOCARDIOGRAM SHOWED THAT ONE OF THE LEAFLETS COULD NOT OPEN; THERE WAS NO DIFFICULTY WITH THE LEAFLET CLOSING. NO ABNORMALITIES OR ANOMALIES WERE OBSERVED PRIOR TO IMPLANT. A NON-ABBOTT VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360550 ↗
• MalfunctionSep 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT PROCEDURE. THE PATIENT WAS TAKING WARFARIN AND LATEST INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.0. DURING DEVICE PREPARATION, FLAP HOLDER USED TO TEST LEAFLET FUNCTION AND THEY CONFIRMED THE LEAFLETS MOVED NORMALLY WHEN TESTED. AFTER THE PROCEDURE, THEY DISCOVERED ABNORMALITIES IN THE OPENING AND CLOSING OF THE VALVE LEAFLETS BEFORE THE HEARTBEAT COULD BE RESTORED. THE VALVE WAS REPLACED WITH A ANOTHER 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE. THE LEAFLET WAS TESTED AFTER THE VALVE WAS NO LONGER IN THE ANNULUS, WHICH WERE NORMAL. THE OPERATION TIME WAS EXTENDED BY 20 MINUTES AND INCREASES THE CARDIOPULMONARY BYPASS TIME BUT THERE WAS NO REPORTED POTENTIAL RISK TO THE PATIENT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311258 ↗
• MalfunctionAug 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM MASTERS VALVE WAS SELECTED FOR IMPLANT. DURING PREP, THE VALVE LEAFLETS WERE MOVING NORMALLY. DURING THE HEART REPLACEMENT PROCEDURE, THE PHYSICIAN DISCOVERED THAT THE VALVES LEAFLETS OPENED AND CLOSED ABNORMALLY. THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER 27MM MASTERS VALVE TO RESOLVE THE EVENT WITHOUT REMOVING THE PATIENT FROM BYPASS. THE EXPLANTED VALVE WAS TESTED AND LEAFLETS WERE MOVING NORMALLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992176 ↗