SJM™ Masters Series 21AECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05414734053884), received between Oct 16, 2018 and Mar 29, 2023 — classified as 1 death, 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2023Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM AORTIC EXPD CUFF MASTERS WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH SEVERE AORTIC REGURGITATION. IT IS UNKNOWN IF AN INTERVENTION WAS PERFORMED. PATIENT STATUS IS UNKNOWN, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16640524 ↗
• InjuryFeb 23, 2022Material Separation; Material Separation

  IT WAS REPORTED, A 21MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS CHOSEN FOR PROCEDURE. DURING THE PROCEDURE WHILE THE USER WAS POSITIONING THE DEVICE AND ROTATED THE VALVE, IT WAS REPORTED THAT THE USER APPLIED INCREASED TENSION TO THE VALVE AS THE IT WAS NOT ROTATING PROPERLY AND THE LEAFLET BROKE. THE DEVICE WAS REMOVED AND EXCHANGED WITH A NEW 21MM SJM MASTERS SERIES VALVE EXPANDED CUFF. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE EVENT DID CAUSE A REPORTED EXTRA 45 MINUTES ON CARDIOPULMONARY BYPASS AND WAS STABLE THROUGHOUT THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587924 ↗
• MalfunctionFeb 17, 2021Material Separation; Device Dislodged or Dislocated

  ON (B)(6) 2021, A 21 MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS SELECTED FOR IMPLANT. WHILE PLACING THE VALVE ONE OF THE LEAFLETS DISLODGED. THE VALVE WAS SUCCESSFULLY REMOVED AND REPLACED WITH A 19 MM SJM MASTERS SERIES VALVE EXPANDED CUFF. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337251 ↗
• InjuryJan 2, 2020Fracture; Fracture

  ON AN UNKNOWN DATE, A 21MM MASTERS MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING IMPLANT, THE VALVE BROKE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9540565 ↗
• InjuryNov 4, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  ON (B)(6) 2019, A 21 MM MASTERS VALVE WAS SELECTED FOR IMPLANT. WHILE ROTATING THE VALVE, THE LEAFLET FRACTURED. THE DEVICE WAS EXPLANTED AND REPLACED WITH A 19 MM MASTERS VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE BUT THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9271281 ↗
• InjurySep 17, 2019Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2018, A 21MM MASTERS VALVE WAS IMPLANTED. ON (B)(6) 2019, THE PATIENT PRESENTED WITH LEAFLET OBSTRUCTION AND THE PHYSICIAN ELECTED TO EXCHANGE THE VALVE FOR A 21MM MASTERS VALVE. THE PHYSICIAN NOTED THERE WAS THROMBUS PRESENT ON THE EXPLANTED VALVE. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: Thrombus

  MAUDE report 9076241 ↗
• InjuryJun 11, 2019Fracture; Fracture

  ON (B)(6) 2019, A 21MM MASTERS VALVE WAS SELECTED FOR IMPLANT IN THE AORTIC POSITION. DURING ROTATION, A LEAFLET OF THE VALVE FRACTURED. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT, AND THERE WAS NO EXTENT TO PROCEDURE TIME NOR ADVERSE CONSEQUENCES TO THE PATIENT. ANOTHER 21MM MASTERS VALVE (SN: (B)(4)) WAS IMPLANTED. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8688146 ↗
• DeathApr 29, 2019Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2019, A 21MM MASTERS SERIES VALVE WAS IMPLANTED IN A (B)(6) FEMALE. ON (B)(6) 2019, THE PATIENT COLLAPSED IN THE ICU. AN ECHO PERFORMED REVEALED ONE OF THE LEAFLETS WAS NOT MOVING AND THE OTHER WAS PARTIALLY COAPTING, RESULTING IN A HIGH GRADIENT AND HYPOTENSION. THE PATIENT'S NATIVE ANNULUS WAS REPORTED TO BE SEVERELY CALCIFIED. A RE-DO PROCEDURE WAS PERFORMED AND THE PATIENT WAS UNABLE TO SUSTAIN THE OPERATION AND EXPIRED ON (B)(6) 2019, DUE TO PERSISTENT HYPOTENSION AND RENAL FAILURE.

  Patient problems: Death; Low Blood Pressure/ Hypotension

  MAUDE report 8562210 ↗
• InjuryOct 16, 2018Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  ON (B)(6) 2018, A 21MM MASTERS VALVE WAS SELECTED. WHEN THE VALVE WAS IMPLANTED AND ROTATED WITH THE RECOMMENDED VALVE ROTATOR, THE LEAFLET FRACTURED INTO TWO PIECES DURING THE ROTATION OF THE VALVE. THE VALVE AND PIECES WERE REMOVED AND A SECOND 21MM MASTERS VALVE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS EXTENDED BY HALF AN HOUR, BUT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES AND IS STABLE AND DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970642 ↗