SJM Tailor™ TARP-31 (UDI 05415067044457)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067044457), received between Mar 17, 2025 and Dec 9, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Lack of Effect” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM TAILOR FLEXIBLE ANNULOPLASTY RING WAS CHOSEN FOR A MINIMALLY INVASIVE CARDIAC SURGERY (MICS). THE RING WAS IMPLANTED. ALTHOUGH APPROPRIATE SIZING WAS PERFORMED, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) CONFIRMED MITRAL REGURGITATION, AND NON-ABBOTT RING DEVICE WAS IMPLANTED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760532 ↗
• MalfunctionDec 4, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM TAILOR FLEXIBLE ANNULOPLASTY RING WAS CHOSEN FOR A PROCEDURE. AFTER IMPLANTATION, A REFLUX OCCURRED. THE RING WAS REPLACED WITH A NEW 31MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE PATIENT WAS STILL ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716321 ↗
• MalfunctionNov 11, 2025Lack of Effect; Lack of Effect

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526041 ↗
• MalfunctionMar 17, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM TAILOR ANNULOPLASTY RING WAS SELECTED FOR IMPLANT. AFTER IMPLANTING THE RING, TESTING REVEALED THAT THERE WAS STILL MODERATE REGURGITATION, WHICH DID NOT ACHIEVE THE EXPECTED EFFECT. AFTER THE RING WAS REMOVED, IT WAS REPLACED WITH A MITRAL VALVULOPLASTY RING OF ANOTHER BRAND TO COMPLETE THE SURGERY. THE PHYSICIAN ALLEGES THAT THE PATIENT ANATOMY WAS THE CAUSE OF THE ISSUE. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE AND HAS BEEN DISCHARGED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21620086 ↗