SJM™ Masters Series HP 21AHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734006002), received between Feb 28, 2019 and Mar 10, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Stenosis” (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.

• MalfunctionMar 10, 2023Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2021, A 21MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2023, THE PATIENT HAD A HIGH GRADIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16525536 ↗
• MalfunctionOct 21, 2020Fracture; Fracture

  ON (B)(6) 2020, A 21MM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR IMPLANT IN THE PATIENT. ONE OF THE LEAFLETS BROKE INTO 3 PIECES AFTER SUTURING THE VALVE IN PLACE. ALL PIECES OF THE BROKEN LEAFLET AND THE VALVE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR A 19MM MASTERS SERIES HEMODYNAMIC PLUS VALVE. THE PHYSICIAN DOES NOT ATTRIBUTE THIS EVENT TO OVERSIZING, THERE WAS NO OTHER SET AND VALVE AVAILABLE AND TIME WAS RUNNING OUT. THE 19MM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SUCCESSFULLY IMPLANTED. THERE WAS A 20-30 MINUTE CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, BUT THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND EXPERIENCED NO SERIOUS INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712439 ↗
• InjuryFeb 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED IN ABBOTT PATIENT DEVICE TRACKING THAT ON (B)(6) 2018, A 21MM MASTERS VALVE WAS IMPLANTED. THE PATIENT HAD AN AORTIC AND MITRAL VALVE REPLACEMENT, AS WELL AS A CORONARY ARTERY BYPASS GRAFT PROCEDURE. THE SURGERY WAS COMPLETED WITHOUT SEQUELAE. IT IS REPORTED THAT THE PATIENT WENT INTO CARDIOGENIC FAILURE AFTER THE PROCEDURE DUE TO AN UNKNOWN CAUSE. THE PATIENT FAMILY DID NOT WANT TO ESCALATE CARE AND THE PATIENT DIED. ABBOTT HAS BEEN INFORMED NO ADDITIONAL DETAILS WILL BE PROVIDED.

  Patient problems: Death; Heart Failure

  MAUDE report 8380760 ↗