Masters Series™ 21AHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067043597), received between Jul 6, 2023 and Oct 20, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 21MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE VALVE WAS INSTALLED AND CHECKED THE VALVE FUNCTION USING VALVE TESTERS. IT WAS NOTED THAT THE VALVE WAS NOT FUNCTIONING COMPLETELY. THE VALVE OPENED VERY SLOWLY AND DID NOT RETRACT. A NEW 21MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS CHOSEN AND IMPLANTED SUCCESSFULLY. AFTER THE PROCEDURE, THE PATIENT WAS HEMODYNAMICALLY STABLE. TWO DAYS AFTER THE PROCEDURE, THE PATIENT WAS REPORTED PASSED AWAY. THE PHYSICIAN MENTIONED THE PATIENT DIED DUE TO HIS HEALTH CONDITION PRIOR TO SURGERY. THE CAUSE OF DEATH WAS HEART FAILURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337294 ↗
• MalfunctionJul 11, 2025Fracture; Fracture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481984 ↗
• MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024, A 21MM MASTERS AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING PROCEDURE, A LEAFLET SUSTAINED DAMAGE; A SMALL FRAGMENT OF THE LEAFLET FRACTURED NEAR THE COSTING EDGE OF THE LEAFLET. NO INSTRUMENTS WERE IN CONTACT WITH THE VALVE AT THE TIME THE FRACTURE WAS OBSERVED. NO RESISTANCE WAS FELT WHEN ROTATING. IT WAS EXCHANGED FOR A NEW 19MM MASTERS AORTIC MECHANICAL HEART VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. OF NOTE, THE PATIENT UNDERWENT A DOUBLE VALVE REPLACEMENT AND AN UNKNOWN SIZED VALVE WAS IMPLANTED INTO THE MITRAL SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096013 ↗
• MalfunctionOct 25, 2023Physical Resistance/Sticking; Device Stenosis; Physical Resistance/Sticking; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS CHOSEN FOR IMPLANT. AFTER THE VALVE WAS SUTURED IN, NORMAL LEAFLET FUNCTION WAS CONFIRMED MANUALLY WITH THE OFFICIAL LEAFLET TESTER. AFTER PROCEDURE, THE PATIENT PASSED A SMOOTH POST-OPERATIVE COURSE. THREE DAYS POST-PROCEDURE, IT WAS OBSERVED DURING PRE-DISCHARGE TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) THE VALVE LEAFLET WAS STUCK IN OPEN POSITION. THIS WAS CONFIRMED THE NEXT DAY ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). IT WAS NOTED THAT THE PRESSURE GRADIENT WAS HIGH, WHICH WAS BELIEVED TO BE DUE TO THE IMPLANTED VALVE. A DECISION WAS MADE TO EXPLANT THE VALVE ON (B)(6) 2023 AND REPLACED WITH ANOTHER 21MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE. THE EXPLANTED VALVE WAS TESTED AGAIN FOR LEAFLET FUNCTION AND FOUND TO MOVE NORMALLY WITH THE LEAFLET TESTER BUT AFTER A FEW MINUTES THE LEAFLET WAS STUCK AGAIN AND NEEDED THE LEAFLET TESTER TO PUSH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS DISCHARGED. 10 DAYS POST-PROCEDURE, THE PATIENT PRESENTED WITH INFECTIVE ENDOCARDITIS ON THE SECOND 21MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE. T

  Patient problems: Aortic Valve Stenosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007722 ↗
• MalfunctionJul 6, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023 A 21MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR AN IMPLANT. POST PROCEDURE, STILL IN PROCEDURE ROOM, IT WAS OBSERVED THAT ONE LEAFLET DID NOT OPEN CONSISTENTLY. DEVICE WAS REPLACED WITH A NEW 21MM SJM MASTERS SERIES MECHANICAL HEART VALVE THAT WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17269338 ↗