Séguin™ SARP-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067044792), received between Apr 3, 2024 and Sep 26, 2025 — classified as 1 injury, 3 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. 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.

• MalfunctionSep 26, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2025, A 28MM SEGUIN SEMI-RIGID SADDLE RING WAS CHOSEN FOR A MITRAL VALVE PLASTY PROCEDURE. DURING PROCEDURE, AFTER SUTURING THE RING, A WATER TEST REVEALED REGURGITATION AROUND THE P2¿P3 REGION. ALTHOUGH THE SUTURES WERE SECURELY TIED, THE REGURGITATION PERSISTED. VARIOUS CORRECTIVE MEASURES WERE ATTEMPTED, BUT THE SITUATION DID NOT IMPROVE. THEREFORE, THE RING WAS TEMPORARILY REMOVED. SINCE THE ORIGINAL MITRAL REGURGITATION WAS NOT OF A PARTICULARLY SEVERE GRADE, THE PROCEDURE WAS ULTIMATELY COMPLETED WITHOUT REIMPLANTING THE ANNULOPLASTY RING. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23154635 ↗
• MalfunctionSep 10, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2025, A 28MM SEGUIN ANNULOPLASTY RING WAS SELECTED FOR IMPLANT. THE ANNULAR DIMENSION WAS 40MM. THE RING WAS IMPLANTED. HOWEVER, POST-OPERATIVE ECHOCARDIOGRAM SHOWED DISTORTED ANNULUS WITH MODERATE/SEVERE REGURGITATION. THE CAUSE OF THE DISTORTED ANNULUS WAS REPORTED AS "RELATIVELY SMALL SIZE ANNULOPLASTY RING WAS USED TO INCREASE THE COAPTATION. THIS LEAD TO DISTORTION OF ANNULUS." SUBSEQUENTLY, THE RING WAS EXPLANTED AND THE VALVE WAS REPAIRED WITH SUTURES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018935 ↗
• MalfunctionOct 30, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM SEGUIN ANNULOPLASTY RING WAS SELECTED FOR IMPLANT. AFTER SUTURING THE SEGUIN RING IN, IT WAS FOUND THAT "THE RING COULD NOT FOLLOW THE NORMAL MOVEMENT OF THE CARDIAC CYCLE." THE PATIENT'S FLAP RING COULD NOT MOVE AFTER THE IMPLANT OF THE SEGUIN RING; THE CAUSE IS UNKNOWN. THE SEGUIN RING WAS SUBSEQUENTLY EXPLANTED. THERE WERE NO ABNORMALITIES OR ANOMALIES OBSERVED WITH THE SEGUIN RING. A NEW 28MM SEGUIN ANNULOPLASTY RING WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567591 ↗
• InjuryApr 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM SEGUIN ANNULOPLASTY RING WAS CHOSEN FOR IMPLANTATION. DURING THE IMPLANTATION, THE RING DISLODGED FROM THE HOLDER HANDLE AND FELL INTO THE LEFT VENTRICULAR CAVITY. THE RING WAS SURGICALLY RETRIEVED AND A REPLACEMENT NON-ABBOTT DEVICE WAS USED TO COMPLETE THE MITRAL VALVE REPLACEMENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT REMAINED ON CARDIOPULMONARY BYPASS THROUGHOUT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19035757 ↗