Rigid Saddle Ring RSAR-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067044679), received between Jul 18, 2024 and May 30, 2025 — classified as 2 injuries.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4), PATIENT SITE ID: (B)(6) (B)(4). IT WAS REPORTED THAT ON (B)(6) 2023, A 28MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED. IT WAS THEN REPORTED ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SYMPTOMATIC ATRIAL FIBRILLATION CONFIRMED VIA ELECTROCARDIOGRAM. A CARDIOVERSION PROCEDURE WAS PERFORMED ON (B)(6) 2023 AND PATIENT RETURNED TO SINUS RHYTHM. THE PATIENT STATUS WAS REPORTED DISCHARGED ON (B)(6) 2023.

  Patient problems: Atrial Fibrillation

  MAUDE report 22114339 ↗
• InjuryJul 18, 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 28MM RIGID SADDLE RING WAS CHOSEN FOR IMPLANT FOR MITRAL VALVE ANNULOPLASTY. IT WAS ALSO REPORTED THE PATIENT RECEIVED CONCOMITANT UNKNOWN TRIFECTA GT VALVE FOR AORTIC VALVE REPLACEMENT. IT WAS REPORTED ON 16 MAY 2024, ECHOCARDIOGRAPHY REPORTED SEVERE MITRAL VALVE INSUFFICIENCY AND MODERATE TRICUSPID VALVE INSUFFICIENCY. IT WAS THEN REPORTED ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED DUE TO WORSENING HEART FAILURE. DURING ECHOCARDIOGRAPHY, IT WAS REPORTED THE TRIFECTA GT VALVE WAS SEVERELY INSUFFICIENT LIKELY ATTRIBUTED TO LEAFLET RUPTURE AND VALVE DETERIORATION. THE PATIENT PRESENTED WITH LUNG EDEMA. THE PATIENT WAS STABILIZED AND A DECISION WAS MADE TO PERFORM SURGICAL INTERVENTION ON (B)(6) 2024 FOR CONCOMITANT MITRAL AND AORTIC VALVE REPLACEMENT WITH TRICUSPID VALVE REPAIR. THE 28MM RIGID SADDLE RING WAS EXPLANTED AND REPLACED WITH A NON-ABBOTT PERICARDIAL VALVE FOR MITRAL REGURGITATION AND ANTERIOR LEAFLET CALCIFICATION. THE TRIFECTA GT VALVE WAS REPLACED WITH A NEW UNKNOWN AORTIC BIOPROSTHETIC VALVE. THE PATIENT'S TRICUSPID VALVE WAS REPAIRED WITH AN UNKNOWN DEVICE. DURING THE INTERVENTION P

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19773017 ↗