Amplatzer™ Septal Occluder (REF 9-ASD-004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811806010014), received between Jun 15, 2020 and Mar 28, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHEN THE DEVICE WAS DEPLOYED, IT PRESENTED IN A COBRA DEFORMATION. THE DEVICE WAS REMOVED AND NEW 4MM AMPLATZER SEPTAL OCCLUDER WAS ATTEMPTED. IT WAS FOUND TO BE TOO SMALL TO PUSH THROUGH THE DEFECT, SO IT WAS REMOVED. A NEW 5MM AMPLATZER SEPTAL OCCLUDER WAS THEN SELECTED FOR USE. WHEN ATTEMPTED, THE 5MM DEVICE WAS ALSO FOUND TO BE TOO SMALL. THERE WAS ALSO LIMITED ROOM IN LEFT ATRIUM FOR A BIGGER DEVICE. THE DECISION WAS MADE TO SURGICALLY CLOSE THE ASD. NO ADVERSE EVENTS OCCURRED WITH THIS PATIENT AND THEY REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, THE PATIENT WAS ON ECMO PRIOR TO PROCEDURE START. THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. THE PATIENT IS RECOVERING IN NORMAL FASHION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21722738 ↗
• MalfunctionJul 8, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022 A 4MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED IN THE PATIENT. IT WAS NOTED THAT IT HAD DEFORMED WHILE IN THE PATIENT, SO IT WAS REMOVED AND REPLACED WITH ANOTHER 4MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961936 ↗
• MalfunctionJun 15, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020 AN AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT. THE DEVICE FORMED A COBRA FORMATION WHILE DEPLOYING. THE PHYSICIAN REPLACED THE DEVICE WITH A COMPETITORS DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE THROUGH AND POST THE PROCEDURE. PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10155397 ↗