SJM™ Masters Series 33MJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734006682), received between Jan 2, 2019 and Aug 18, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 33MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANT. AFTER THE VALVE WAS IMPLANTED, IT WAS FOUND THE VALVE COULD NOT BE ROTATED. IT WAS REPORTED THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT 90 DEGREE ANGLE AND NO OTHER TOOL WAS USED TO POSITION OR ROTATE THE VALVE. A DECISION WAS MADE TO EXPLANT THE DEVICE AND REPLACE WITH A 33MM NON-ABBOTT VALVE. THE REPLACEMENT VALVE WAS SUCCESSFULLY IMPLANTED WITH NO ADVERSE PATIENT CONSEQUENCES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574582 ↗
• InjuryJun 2, 2021Material Separation; Material Separation

  IT WAS REPORTED ON (B)(6) 2021, A 33MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED. AN INTRA OPERATIVE ECHOCARDIOGRAM DEMONSTRATED TWO FUNCTIONING LEAFLETS WITH GOOD VISIBILITY. THE PATIENT WAS NEVER EXTUBATED IN THE INTENSIVE CARE UNIT (ICU) POST THE IMPLANT SURGERY. ON (B)(6) 2021, THE PATIENT WAS EXTUBATED AND REQUIRED SOME CONTINUOUS POSITIVE AIRWAY PRESSURE/BILEVEL POSITIVE AIRWAY PRESSURE (CRAP/BIBAP/VENTILATION SUPPORT). ON (B)(6) 2021, PATIENT WAS BEING PREPPED TO BE TRANSFERRED TO THE TO THE WARD FROM THE ICU. THE PATIENT BEGAN TO DETERIORATE OVER THE COURSE OF 6 HOURS. THE PATIENT INITIALLY REQUIRED NON INVASIVE VENTILATION BUT WORSENING RESPIRATORY DISTRESS REQUIRED REINTUBATION DURING THE EVENT OF THE (B)(6) AND CARDIOGENIC SHOCK WAS NOTED. ON (B)(6) 2021, IT WAS NOTED THAT THE VALVE'S LEAFLET WAS MISSING DURING A TRANSESOPHAGEAL ECHO (TOE) AND THE PATIENT WAS CLINICALLY DETERIORATED. THE PATIENT WAS REPORTED AS CLINICALLY UNSTABLE. ON (B)(6) 2021, THE VALVE WAS EXPLANTED AND REPLACED WITH A NEW 31MM SJM MASTERS SERIES MECHANICAL HEART VALVE. DURING REPLACEMENT SURGERY THE MISSING LEAFLET WAS NOT LOCATED AND REMAINED IN THE PATIENT. THE PATIENT WENT INTO CAR

  Patient problems: Cardiogenic Shock

  MAUDE report 11924947 ↗
• InjuryJan 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, A 33MM MASTERS VALVE WAS SELECTED FOR IMPLANT IN THE MITRAL POSITION. THE VALVE WAS ROTATED INITIALLY WITH THE VALVE ROTATOR FOLLOWED BY FORCEPS. DURING THIS ROTATION, BOTH LEAFLETS DISLODGED AND ONE FRACTURED INTO MULTIPLE PIECES. THE VALVE WAS EXPLANTED AND THE LEAFLET AND FRACTURED PIECES WERE SUCCESSFULLY RETRIEVED, EXTENDING THE PROCEDURE TIME BY ONE HOUR. THE DEVICE WAS EXCHANGED FOR A 33 MASTERS VALVE AND WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8210516 ↗