SJM™ Masters Series 21ATJ-503Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734028578), received between Jun 16, 2023 and Jun 16, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2023Incomplete Coaptation; Patient-Device Incompatibility; Device Stenosis; Incomplete Coaptation; Patient-Device Incompatibility; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2002, A 21MM MASTERS SERIES HEART VALVE WITH TEFLON CUFF WAS SUCCESSFULLY IMPLANTED IN A PATIENT'S AORTIC VALVE. IN (B)(6) 2023, THE PATIENT HAD A MEDICAL EXAMINATION AND THE PATIENT DISPLAYED SYMPTOMS OF AORTIC STENOSIS: SHORTNESS OF BREATH/DYSPNEA ON EXERTION. AN ECHOCARDIOGRAM (ECHO) WAS PERFORMED, AND MILD-MODERATE AORTIC STENOSIS WAS CONFIRMED. IN MAY, THE AORTIC STENOSIS PROGRESSED, AND IT WAS DECIDED THAT VALVE REPLACEMENT WAS NECESSARY. ON (B)(6) 2023, THE DEVICE WAS EXPLANTED AND A 19MM EPIC VALVE WAS IMPLANTED. PANNUS WAS SEEN CIRCUMFERENTIALLY ON THE INFLOW SIDE OF THE MASTERS VALVE, WHICH INDICATED THAT THE VALVE WAS NOT COMPLETELY OPENING. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 17144562 ↗