SJM Tailor™ TARP-25Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067044419), received between Nov 21, 2025 and Apr 17, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Lack of Effect1
Patient problems
- Anemia1
- Hemolysis1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
Other RING, ANNULOPLASTY devices
- CG FUTURE™ 638BL32Medtronic, Inc. · RING, ANNULOPLASTY1 death71 reports
- PROFILE 3D® 680R28Medtronic, Inc. · RING, ANNULOPLASTY1 death67 reports
- 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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