SJM Tailor™ TARP-29 (UDI 05414734007696)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734007696), received between Apr 12, 2021 and Aug 7, 2024 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionAug 7, 2024Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2024, A 29MM TAILOR ANNULOPLASTY RING WAS SELECTED FOR IMPLANT TO REPAIR A MITRAL VALVE. NO ASSOCIATED PATIENT SYMPTOMS WERE REPORTED. AFTER IMPLANT, MILD-MODERATE MITRAL REGURGITATION WAS STILL PRESENT VIA FOLLOW UP IMAGING, THEREFORE THE RING WAS EXPLANTED AND THE VALVE WAS REPLACED WITH A NON-ABBOTT DEVICE. THE PATIENT WAS NOT CLOSED PRIOR TO EXPLANTING THE RING. THE PATIENT STATUS WAS REPORTED AS STABLE. NO PATIENT CONSEQUENCES WERE REPORTED. THERE ARE NO ALLEGATIONS OF MALFUNCTION WITH THE RING AND THERE ARE NO ALLEGATIONS TO THE SIZING OF THE RING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929131 ↗
• InjuryApr 12, 2021Off-Label Use; Off-Label Use

  ON (B)(6) 2017, A 29MM TAILOR FLEXIBLE ANNULOPLASTY RING WAS IMPLANTED IN THE AORTIC VALVE POSITION DURING A BICUSPID AORTIC VALVE REPAIR AND ASCENDING AORTA REPLACEMENT PROCEDURE IN A (B)(6) YEAR-OLD WOMAN. DURING THE PROCEDURE, THE DEVICE WAS PLACED BENEATH THE CORONARY OSTIA. THE PATIENT'S LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS INJURED, WITH THE RESULT OF A MASSIVE LEFT VENTRICULAR ISCHEMIC INJURY(POST-OPERATIVE EJECTION FRACTION OF 10-15%), THE NEED FOR PROLONGED VASOPRESSOR, VENTRICULAR ASSIST DEVICE AND CARDIORESPIRATORY SUPPORT(TRACHEOSTOMY), A LITANY OF RELATED MULTISYSTEM INJURIES INCLUDING FOREFOOT AMPUTATIONS AND RENAL FAILURE, AND THE IMPLANTATION OF A LEFT VENTRICULAR ASSIST DEVICE(LVAD) AS A BRIDGE TO AN EVENTUAL HEART TRANSPLANTATION PERFORMED ON (B)(6) 2017 AT THE HOSPITAL (B)(6).

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Ischemia; Renal Failure

  MAUDE report 11654031 ↗