SJM Tailor™ TARP-29 (UDI 05415067044433)Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067044433), received between Jul 12, 2024 and Jul 21, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Lack of Effect” (3 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, 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
- Lack of Effect3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Mitral Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 3 most recent of 3 reports, 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 ↗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 ↗
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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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