SJM Tailor™ TARP-33Recalls & 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 05414734007719), received between Jan 18, 2022 and May 2, 2023 — classified as 2 injuries.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Lack of Effect1
Patient problems
- Heart Block1
- Mitral Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2023Lack of Effect; Lack of Effect
IT WAS REPORTED THAT ON (B)(6) 2023, A 33MM TAILOR FLEXIBLE ANNULOPLASTY RING WAS CHOSEN FOR IMPLANT IN A MITRAL VALVE PROLAPSE PROCEDURE. THE ANNULUS WAS MEASURED TO BE 30.3MM AT THE ANTERIOR-POSTERIOR (AP) AND 43.1MM COMMISSURE-COMMISSURE (CC) AXES. AFTER THE RING WAS IMPLANTED, MILD MITRAL REGURGITATION (MR) WAS PRESENT BUT CONTROLLED IN A TEST. SYSTOLIC ANTERIOR MOTION (SAM) WAS OBSERVED, AND THE REGURGITATION PROGRESSED TO MODERATE SEVERITY. THE HEART WAS RE-STOPPED, THE RING WAS REMOVED AND A 35MM TAILOR FLEXIBLE ANNULOPLASTY RING WAS THEN IMPLANTED. AFTER THE REPLACEMENT RING WAS IMPLANT, REGURGITATION WAS NO LONGER PRESENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 16855895 ↗InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(CLINICAL STUDY PATIENT ID: (B)(6)). IT WAS REPORTED THAT ON (B)(6) 2021, A 33 MM TAILOR FLEXIBLE ANNULOPLASTY RING WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2021, THE PATIENT PRESENTED WITH ATRIOVENTRICULAR BLOCK TYPE 3. A PACEMAKER WAS SUCCESSFULLY IMPLANTED TO RESOLVE THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Heart Block
MAUDE report 13281822 ↗
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- CG FUTURE™ 638BL30Medtronic, Inc. · RING, ANNULOPLASTY1 death65 reports
- CG FUTURE™ 638RL32Medtronic, Inc. · RING, ANNULOPLASTY59 reports
- Tri-Ad™ 900SFC228Medtronic, Inc. · RING, ANNULOPLASTY4 deaths56 reports
- CG FUTURE™ 638BL34Medtronic, Inc. · RING, ANNULOPLASTY51 reports
- Contour 3D® 690R30Medtronic, Inc. · RING, ANNULOPLASTY1 death50 reports
- CG FUTURE™ 638BL28Medtronic, Inc. · RING, ANNULOPLASTY1 death47 reports
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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