Rigid Saddle Ring RSAR-30Recalls & reported problems
St. Jude Medical, Inc. · Rigid Saddle Ring · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067044693), received between Sep 23, 2024 and Jun 5, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Lack of Effect” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Lack of Effect2
Patient problems
- Mitral Valve Insufficiency/ Regurgitation1
- 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.
MalfunctionJun 5, 2026Lack of Effect
IT WAS REPORTED THAT ON (B)(6) 2026, A 30MM RING - RIGID SADDLE WAS CHOSEN FOR A MITRAL VALVE REPAIR PROCEDURE. ON POST OPERATIVE ECHOCARDIOGRAM (ECHO) SHOWED DISTORTED ANNULUS WITH MODERATE REGURGITATION. HENCE RING WAS EXPLANTED & AGAIN THE VALVE WAS REPAIRED WITH SUTURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414791 ↗MalfunctionSep 23, 2024Lack of Effect; Lack of Effect
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- 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™ 638RL30Medtronic, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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