SJM Regent™ 27AGN-751Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734006392), received between Mar 9, 2023 and Mar 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 16, 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.

• MalfunctionMar 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2023 A 27MM REGENT AORTIC MHV, WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, AS THE IMPLANTING PHYSICIAN PUT 2 SUTURES INTO THE CUFF OF THE VALVE, THE SEWING CUFF FABRIC LOOSENED FROM THE CUFF AND THE DEVICE WAS NEVER PARACHUTED DOWN IN THE ANNULUS. THE DEVICE WAS NEVER IMPLANTED IN THE PATIENT. THE QA SEAL ON THE PRODUCT BOX WAS INTACT AND THE PRODUCT BOX CONTAINING THE DEVICE DID NOT APPEARED DAMAGED IN ANY WAY OR WAS DAMAGED DUE TO HANDLING DURING PREPARATION. DEVICE WAS REPLACED WITH A 27MM REGENT AORTIC MHV DEVICE THAT WAS SUCCESSFULLY IMPLANTED. THE REST OF THE SURGERY WENT WELL WITHOUT ANY ADVERSE EVENTS. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518631 ↗