SJM Tailor™ TARP-31 (UDI 05414734007702)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734007702), received between Aug 28, 2019 and Dec 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Lack of Effect” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2022Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2022, A 31MM TAILOR FLEXIBLE ANNULOPLASTY RING WAS SUCCESSFULLY IMPLANTED IN A PATIENT. AFTER IMPLANT, A SALINE TEST WAS PERFORMED AND IT WAS DEEMED THAT THE REPAIR USING THE RING WAS INCOMPETENT. THE DECISION WAS MADE TO EXPLANT THE 31MM TAILOR FLEXIBLE ANNULOPLASTY RING AND USE A DEBEGA TECHNIQUE TO FURTHER REPAIR THE PATIENT'S TRICUSPID VALVE. NO MALFUNCTION OF THE RING WAS REPORTED. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15981977 ↗
• MalfunctionAug 28, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019, A 31MM TAILOR FLEXIBLE ANNULOPLASTY RING WAS IMPLANTED FOLLOWING THE EXPIRATION DATE. NO PATIENT CONSEQUENCES WERE REPORTED. THE PRODUCT WAS REPORTED TO HAVE EXPIRED ON 01 JULY 2019. PER THE SITE, THE VEKTÖR AGENT DID NOT RETRIEVE THE EXPIRED STOCK FROM THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8942186 ↗