Masters Series™ 25AHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067043634), received between Sep 21, 2026 and Sep 21, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Incomplete Coaptation” (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.

• InjurySep 21, 2026Incomplete Coaptation

  It was reported that on (b)(6) 2026, a 25mm SJM Masters Series Hemodynamic Plus Valve was chosen for a procedure. During procedure, an inability of the valve to open was noted after weaning from cardiopulmonary bypass, during intraoperative transesophageal echocardiogram (TEE) assessment. The patient was placed back on cardiopulmonary bypass for explanation of the valve and implantation of the biological valve. The patient need for repeat cardiopulmonary bypass and valve replacement resulted in prolonged cardiopulmonary bypass and myocardial ischemic times. The patient was reported stable.

  Patient problems: Myocardial Infarction

  MAUDE report 50845798 ↗