Séguin™ SARP-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067044815), received between Apr 9, 2024 and Nov 4, 2025 — classified as 1 injury, 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT IN (B)(6) 2025, A 30MM SEMI-RIGID SADDLE RING WAS CHOSEN FOR A MITRAL VALVULOPLASTY PROCEDURE. POST-IMPLANTATION TESTING REVEALED THAT THERE WAS STILL MODERATE REGURGITATION, WHICH DID NOT ACHIEVE THE EXPECTED EFFECT. AFTER REMOVING THE VALVE, THE PATIENT WAS REPLACED WITH AN ARTIFICIAL MITRAL VALVE TO COMPLETE THE OPERATION. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468658 ↗
• MalfunctionMar 18, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM SEGUIN ANNULOPLASTY RING WAS SELECTED FOR IMPLANT. THE GRADE OF MITRAL REGURGITATION PRIOR TO PROCEDURE WAS SEVERE. THE RING WAS IMPLANTED. POST-IMPLANT, TESTING WAS PERFORMED AND SHOWED THAT THERE WAS STILL MODERATE REGURGITATION. THE RING WAS REMOVED AND REPLACED WITH AN UNKNOWN SIZED NON-ABBOTT ARTIFICIAL MITRAL VALVE. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635983 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE "VALVE-IN-RING TRANSCATHETER MITRAL VALVE REPLACEMENT IN A FLUOROSCOPICALLY INVISIBLE RING" WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 84-YEAR-OLD MAN WHO UNDERWENT MITRAL ANNULOPLASTY WITH A 30-MM SEGUIN RING IN 2002 DEVELOPED SEVERE MITRAL REGURGITATION (MR). ECHOCARDIOGRAPHY SHOWED LEFT VENTRICULAR EJECTION FRACTION OF 40%, SEVERE MR WITH AN EFFECTIVE REGURGITANT ORIFICE AREA OF 0.4 CM2, DIMINUTIVE POSTERIOR MITRAL VALVE LEAFLET, AND A MITRAL VALVE GRADIENT OF 17/5 MM HG. HE WAS DEEMED HIGH RISK FOR REPEAT SURGERY AND ANATOMICALLY UNFAVORABLE FOR TRANSCATHETER EDGE-TO-EDGE REPAIR. HEART TEAM CONSENSUS WAS TO PERFORM VALVE-IN-RING TRANSCATHETER MITRAL VALVE REPLACEMENT. GIVEN THE PROXIMITY OF THE LEFT CIRCUMFLEX ARTERY (LCX) TO THE MITRAL ANNULUS, DURING PREPROCEDURE COMPUTED TOMOGRAPHY ANALYSIS, ITS COURSE ALONG THE CIRCUMFERENCE OF THE SEGUIN RING AND DEPLOYMENT ANGLE WAS DETERMINED. THE MITRAL ANNULAR AREA WAS 553.6 MM2 , AND A 29-MM SAPIEN 3 (EDWARDS LIFESCIENCES) TRANSCATHETER HEART VALVE (THV) WAS CHOSEN. ANTERIOR MITRAL LEAFLET MODIFICATION WAS NOT REQUIRED GIVEN THE FACT THAT THE NEO¿LEFT VENTRICULAR OUTFLOW TRACT AREA WAS 500 MM. A CORONARY WIRE WA

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20352159 ↗
• MalfunctionApr 9, 2024Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2024, A 30MM SEGUIN SEMI-RIGID SADDLE RING WAS CHOSEN FOR A MITRAL ANNULUS REPAIR SURGERY. THE RING WAS SUCCESSFULLY IMPLANTED. AFTER THE IMPLANTATION, THROUGH WATER PUMPING TEST IT WAS FOUND THAT THE MITRAL REGURGITATION GOT WORSENED, SO THE RING WAS REMOVED. A NEW 30MM NON-ABBOTT RING WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19073074 ↗