SJM TailorRecalls & reported problems across all models

We found 12 models of SJM Tailor by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2019 and Jul 21, 2026 — classified as 12 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Lack of Effect” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SJM Tailor problems

SJM Tailor models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SJM Tailor™ TARP-31

  RING, ANNULOPLASTY
  4 reports
• SJM Tailor™ TARP-29

  RING, ANNULOPLASTY
  3 reports
• SJM Tailor™ TARP-29

  RING, ANNULOPLASTY
  2 reports
• SJM Tailor™ TARP-31

  RING, ANNULOPLASTY
  2 reports
• SJM Tailor™ TARP-33

  RING, ANNULOPLASTY
  2 reports
• SJM Tailor™ TARP-35

  RING, ANNULOPLASTY
  2 reports
• SJM Tailor™ TAB-29

  RING, ANNULOPLASTY
  2 reports
• SJM Tailor™ TARP-25

  RING, ANNULOPLASTY
  2 reports
• SJM Tailor™ TARP-27

  RING, ANNULOPLASTY
  1 report
• SJM Tailor™ TAB-31

  RING, ANNULOPLASTY
  1 report
• SJM Tailor™ TAB-35

  RING, ANNULOPLASTY
  1 report
• SJM Tailor™ TAB-29

  RING, ANNULOPLASTY
  1 report

Recent SJM Tailor adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2026Lack of Effect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25896715 ↗
• MalfunctionJun 26, 2026Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2026, A 29MM TAILOR ANNULOPLASTY RING WAS CHOSEN FOR A TRICUSPID REPAIR. POST OPERATIVE ECHOCARDIOGRAM SHOWED DISTORTED ANNULUS WITH MODERATE REGURGITATION. HENCE RING WAS EXPLANTED & AGAIN REPAIRED WITH A 27MM TAILOR ANNULOPLASTY RING WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25634531 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (b)(6) 2026, A 27MM TAILOR FLEXIBLE ANNULOPLASTY RING WAS IMPLANTED IN THE PATIENT. POSTOPERATIVELY, THE PATIENT HAD PERSISTENT HEMATURIA AND HEMOGLOBIN (HB) REMAINED LOW AFTER BLOOD TRANSFUSION. AN UNEXPLAINED HEMOLYSIS OCCURRED. A REOPERATION WAS PERFORMED ON (b)(6) 2026, THE RING GOT EXPLANTED AND A NEW 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND IS CURRENTLY STABLE.

  Patient problems: Anemia; Hemolysis

  MAUDE report 24912670 ↗
• 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 21, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM TAILOR FLEXIBLE ANNULOPLASTY RING WAS CHOSEN FOR A PROCEDURE. AFTER IMPLANTING, THE LEAD SURGEON FOUND THAT THE MITRAL VALVE LEAFLETS WERE NOT WELL COAPTED AND THE RESHAPING EFFECT WAS UNSATISFACTORY. THE VALVE WAS REPLACED WITH A NEW 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE AND THE PROCEDURE COMPLETED SUCCESSFULLY WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617820 ↗
• MalfunctionNov 11, 2025Lack of Effect; Lack of Effect

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526041 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 35MM TAILOR ANNULOPLASTY RING WAS IMPLANTED. POST-PROCEDURALLY, IT WAS REPORTED ON (B)(6) 2024, THE PATIENT HAD A 2MM STERNAL DISJUNCTION THAT WAS WELL TOLERATED. THE PATIENT WAS INDICATED FOR STERNAL RESYNTHESIS IN VIEW OF PERSISTENT STERNAL PSEUDO-OSTEOARTHRITIS. IT WAS REPORTED MEDICAL THERAPY WAS PROVIDED. THE PATIENT STATUS WAS REPORTED STABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22159474 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 12, 2024Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON 18 JUNE 2024, A 29MM TAILOR ANNULOPLASTY RING WAS SELECTED FOR IMPLANT. THE DIMENSIONS OF THE NATIVE VALVE ARE NOT AVAILABLE. THE MITRAL VALVE WAS SIZED WITH A TARP SIZER SET. AFTER THE RING WAS IMPLANTED, DURING SALINE TEST, IT WAS DETERMINED THAT THERE WAS SIGNIFICANT REGURGITATION; FURTHER DESCRIBED AS MODERATE. THE 29MM RING WAS EXPLANTED AND REPLACED WITH A NEW 30MM RIGID SADDLE RING, WHICH WAS SUCCESSFULLY IMPLANTED. THERE ARE NO ALLEGATIONS OF MALFUNCTION WITH THE FIRST RING. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19727554 ↗
• InjuryMay 3, 2024Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2024, A 29MM TAILOR FLEXIBLE ANNULOPLASTY BAND WAS CHOSEN FOR A MITRAL VALVE PLASTY (MVP) PROCEDURE. THE DEVICE WAS IMPLANTED. WHEN REMOVING CARDIOPULMONARY BYPASS, SYSTOLIC ANTERIOR MOVEMENT (SAM) WAS OBSERVED IN ECHOCARDIOGRAPHY. THE BAND WAS EXPLANTED, AND A 36MM NON-ABBOTT DEVICE WAS IMPLANTED BEFORE CLOSING PATIENT'S CHEST. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19241501 ↗
• 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 ↗
• InjuryJun 12, 2023Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM TAILOR FLEXIBLE ANNULOPLASTY BAND WAS CHOSEN FOR IMPLANT. PRIOR TO IMPLANT, BLOOD FLOW WAS INTERRUPTED TO PLACE THE BAND. AFTER THE BAND WAS IMPLANTED, BLOOD FLOW WAS RELEASED, AND MITRAL VALVE SYSTOLIC ANTERIOR MOVEMENT (SAM) WAS CONFIRMED VIA ECHOCARDIOGRAM. THE TAILOR VALVE WAS REMOVED AND A 36MM NON-ABBOTT VALVE WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17110118 ↗
• InjuryMay 17, 2023Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM SJM TAILOR¿ ANNULOPLASTY RING WAS SELECTED FOR IMPLANT TO REPAIR THE MITRAL VALVE. AFTER IMPLANTATION OF THE TAILOR RING, THE PHYSICIAN FOUND THAT THERE WAS STILL A MODERATE REGURGITATION. THE PHYSICIAN ALLEGED THAT THE MATERIAL OF THE TAILOR RING WAS TOO SOFT TO RESHAPE THE ANNULAR. BECAUSE OF THIS, THE ANTERIOR LEAFLET AND THE POSTERIOR LEAFLET COULDN¿T ALIGN WELL. THE PHYSICIAN EXPLANTED THE MITRAL RING AND IT WAS REPLACED WITH A 27MM MASTERS MECHANICAL HEART VALVE INSTEAD. THE PROCEDURE TIME WAS EXTENDED ABOUT 25 MINUTES. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND IS CURRENTLY SAFE AND STABLE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16948681 ↗

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