SJM Tailor™ TARP-27Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734007689), received between May 17, 2023 and May 17, 2023 — classified as 1 injury.
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
- Lack of Effect1
Patient problems
- Mitral Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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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- 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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