SJM Tailor™ TARP-35Recalls & reported problems
St. Jude Medical, Inc. · ANNULOPLASTY RING · Class 2 · Implant
All models of SJM Tailor (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734007726), received between May 13, 2022 and Jun 6, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Arrhythmia1
- Heart Failure/Congestive Heart Failure1
- Post Operative Wound Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2022, A 35MM TAILOR ANNULOPLASTY RING WAS CHOSEN FOR IMPLANT. AT THE END OF THE PROCEDURE, THERE WAS SEVERE LEFT VENTRICULAR (LV) DYSFUNCTION, WHICH REQUIRED HIGH DOSE INOTROPES AND INTRA-AORTIC BALLOON PUMP (IABP). THERE WAS SLOW INOTROPE WEANING AND NEED FOR NONINVASIVE MOTION VENTILATION (NIMV) DUE TO HYPOXIA. ON (B)(6) 2022, IABP WAS REMOVED. IT WAS NOTED THAT THE PATIENT HAD MODERATE DEPRESSION OF LEFT VENTRICULAR FUNCTION AT BASELINE AND THAT IT WAS NOT UNEXPECTED AFTER INTERVENTION. IT WAS NOTED THAT THE DEVICE WAS OPERATING AS EXPECTED. NO OTHER COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED IN GOOD CLINICAL CONDITION ON (B)(6) 2022. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Arrhythmia; Heart Failure/Congestive Heart Failure
MAUDE report 14392331 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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