Séguin™ SARP-36Recalls & reported problems
St. Jude Medical, Inc. · Annuloplasty Ring for Mitral Valve Repair · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067044877), received between Nov 21, 2025 and Nov 21, 2025 — classified as 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
- Lack of Effect1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Lack of Effect; Lack of Effect
IT WAS REPORTED THAT ON (B)(6) 2025, A 36MM SEGUIN ANNULOPLASTY RING WAS CHOSEN FOR A MITRAL VALVE REPAIR SURGERY. AFTER THE SUCCESSFUL IMPLANTATION OF THE ANNULOPLASTY RING, THE PHYSICIAN FOUND THAT THERE WAS STILL OBVIOUS REGURGITATION OF THE MITRAL VALVE DURING TESTING. THEREFORE, THEY DECIDED TO REMOVE THE SEGUIN ANNULOPLASTY RING AND REPLACE IT WITH AN NON-ABBOTT RING OF THE SAME MODEL FOR REIMPLANTATION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO REGURGITATION OBSERVED AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617770 ↗
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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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