Rigid Saddle Ring RSAR-26Recalls & reported problems
St. Jude Medical, Inc. · Rigid Saddle Ring · Class 2 · Implant
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 05415067044655), received between Nov 4, 2024 and Nov 12, 2024 — 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
- Angina1
- Fever1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Pericarditis1
- Pleural Effusion1
- Pneumonia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CRD_985 - ARB PMCF, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 26MM SJM RIGID SADDLE RING WAS CHOSEN FOR MITRAL VALVE REPAIR. IT WAS ALSO REPORTED THE PATIENT UNDERWENT CONCOMITANT COMMISSUROTOMY TO TREAT MITRAL STENOSIS AND ALSO LEFT ATRIAL APPENDAGE CLOSURE. IT WAS REPORTED PRIOR TO DISCHARGE ON (B)(6) 2022, PLEURAL EFFUSION WAS DETECTED DURING FOLLOW-UP CHEST X-RAY AND A DECISION WAS MADE TO PERFORM A PLEURAL PUNCTURE FOR PLEURAL EFFUSION DRAINAGE. A FOLLOW-UP CHEST X-RAY ON (B)(6) 2022 REPORTED NO PATHOLOGY. IT WAS THEN REPORTED ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR FEVER, CHEST PAIN, PNEUMONIA, AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2022. THE PATIENT WAS REHOSPITALIZED ON (B)(6) 2022 DUE TO WORSENING PLEURAL EFFUSION. A REPEAT CHEST X-RAY ON (B)(6) 2022 DID NOT CONFIRM PLEURAL EFFUSION. A COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2022 NOTED MINIMAL PLEURAL EFFUSION. THE PATIENT WAS DISCHARGED (B)(6) 2022 FOLLOWING NO TREATMENT. IT WAS THEN REPORTED ON (B)(6) 2022, THE PATIENT PRESENTED AGAIN WITH SLIGHT PAIN AND CHEST DISCOMFORT THAT WAS WORSENED WITH BREATHING DEEPLY. IT WAS ALSO NOTED THE PATIENT HAD
Patient problems: Angina; Fever; Pain; Pericarditis; Pleural Effusion; Pneumonia
MAUDE report 20663380 ↗MalfunctionNov 4, 2024Lack of Effect; Lack of Effect
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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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