SJM™ Masters Series 19AECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734053877), received between Jul 3, 2018 and May 19, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023 A 19MM SJM MASTERS SERIES VALVE W/ EXPANDED CUFF WAS CHOSEN FOR IMPLANT. THE PATIENT'S AORTIC ANNULUS WAS SIZED 19MM VIA A MECHANICAL SIZER SET. AFTER THE DEVICE WAS IMPLANTED, THE OPERATOR ATTEMPTED TO ROTATE THE VALVE IN SITU, FELT RESISTANCE, AND WAS UNABLE TO ROTATE WHEN ONE OF THE LEAFLETS HAD FRACTURED INTO THREE PIECES. IT WAS REPORTED NO OTHER INSTRUMENTS ENCOUNTERED THE VALVE AT THE TIME OF FRACTURE AND ALL OF THE LEAFLET FRACTURED PIECES WERE REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED ONLY THE HOLDER HANDLE WAS USED TO ROTATE THE VALVE, THE HOLDER HANDER WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE, AND THE VALVE WAS IN A CLOSED POSITION WHEN ROTATED. A DECISION WAS MADE TO EXPLANT THE VALVE AND A NEW 19MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED IN THE PATIENT WITH NO ADVERSE PATIENT CONSEQUENCES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THEIR STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16969670 ↗
• MalfunctionMay 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6)2023, A 19MM MASTERS SERIES VALVE EXPANDED CUFF WAS SELECTED FOR AN IMPLANT. THE SURGEON SIZED THE AORTIC ANNULUS WITH THE HELP OF 905 SIZER SET, WHILE ROTATING THE VALVE ONE OF THE LEAFLET FOUND BROKEN INTO TWO PIECES AND WAS RECOVERED FROM THE PATIENT. DEVICE WAS EXPLANTED, AND A NEW 19MM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943711 ↗
• InjuryAug 27, 2021Material Separation; Material Separation

  SUBSEQUENTLY TO THE INITIALLY FILED INFORMATION, THE FOLLOWING INFORMATION WAS CONFIRMED. "THE DEVICE WAS REMOVED AND ALL LEAFLETS WERE RETRIEVED."

  Patient problems: Aortic Valve Stenosis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12376988 ↗
• InjuryJan 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2019, A 19MM MASTERS SERIES VALVE WAS SELECTED FOR IMPLANT. DURING PLACEMENT OF THE VALVE HOLDER WAS REMOVED AND ONE OF THE LEAFLETS BROKE AND FELL DOWN INTO THE LEFT VENTRICLE CAVITY. THE VALVE WAS REMOVED AND EXCHANGED FOR A 17MM MASTERS SERIES VALVE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT WAS REPORTED TO BE INSTABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547306 ↗
• InjuryFeb 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2016, A 19MM MASTERS VALVE WAS IMPLANTED. ON (B)(6) 2019, THE 19MM MASTERS VALVE WAS EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT MADE AVAILABLE BY THE HOSPITAL OR PHYSICIAN.

  Patient problems: No Information

  MAUDE report 8346302 ↗
• InjuryJul 3, 2018Fracture; Fracture

  A 19MM MASTERS SERIES VALVE WAS CHOSEN FOR IMPLANT IN THE AORTIC ANNULUS. AFTER THE VALVE WAS IMPLANTED, TWO ATTEMPTS WERE MADE TO ATTACH THE HOLDER HANDLER TO ROTATE THE VALVE; HOWEVER, DUE TO THE ADMINISTRATION OF CARDIOPLEGIA A VIEW OF THE SURGICAL FIELD WAS LOST. ATTEMPTS TO ROTATE THE VALVE WERE ABANDONED AND CLOSURE OF THE AORTOTOMY BEGAN. WHEN THE SURGICAL FIELD WAS CLEAR OF BLOOD, ONE OF THE VALVE LEAFLETS WAS OBSERVED TO BE SPLIT IN HALF. THE TWO PIECES WERE REMOVED FROM THE LEFT CORONARY SINUS, THE VALVE EXPLANTED, AND A SECOND 19MM MASTERS SERIES VALVE WAS IMPLANTED. ALTHOUGH NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED, THE PROCEDURE TIME WAS EXTENDED BEYOND 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7660654 ↗