SJM Tailor™ TAB-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734055727), received between Sep 27, 2023 and Sep 27, 2023 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4)., PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 35MM TAILOR FLEXIBLE ANNULOPLASTY BAND WAS SUCCESSFULLY IMPLANTED IN A PATIENT. IT WAS NOTED THAT DURING PROCEDURE THERE WAS MILD LEFT AND RIGHT VENTRICULAR DYSFUNCTION, THAT WAS TREATED WITH INOTROPES. THERE WAS NO DIFFICULTY IMPLANTING THE 35MM TAILOR FLEXIBLE ANNULOPLASTY BAND. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. IT WAS ALSO NOTED THAT THE PATIENT HAD AN AORTIC VALVE REPAIR DONE DURING THE SAME SURGERY. ON (B)(6) 2023, IT WAS NOTED THAT THE PATIENT HAD AN EPISODE OF ATRIAL FIBRILLATION WHILE IN THE INTENSIVE CARE UNIT. PREOPERATIVE FINDINGS INDICATE THAT THE PATIENT HAD DEGENERATIVE, FIBROELASTIC DEFICIENCY OF THE NATIVE MITRAL VALVE. THE DECISION WAS MADE TO ADMINISTER INTRAVENOUS CORDARONE. THERE WAS NO IMPLANT OF A PERMANENT PACEMAKER REQUIRED. THE ONSET OF ATRIAL FIBRILLATION IS ATTRIBUTED TO THE IMPLANT PROCEDURE. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Atrial Fibrillation

  MAUDE report 17826640 ↗