AMPLATZER™ 9-ASD-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067019134), received between Aug 12, 2022 and Jan 17, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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.

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.

• MalfunctionJan 17, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 5MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DEPLOYED IN A COBRA APPEARANCE. THE PHYSICIAN RECAPTURED THE OCCLUDER AND ATTEMPTED TO REDEPLOY THE DEVICE FOUR TIMES, BUT IT CONTINUED TO DEPLOY IN A COBRA APPEARANCE. THE DEFORMED DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE OCCLUDER WAS REMOVED AND MASSAGED BUT IT DID NOT RETURN TO THE NORMAL SHAPE. THEN, A 6MM AMPLATZER SEPTAL OCCLUDER WAS THEN CHOSEN FOR IMPLANT. THE REPLACEMENT DEVICE SUCCESSFULLY IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185826 ↗
• InjuryAug 12, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 5MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SUCCESSFULLY IMPLANTED IN A PATIENT. IT WAS NOTED THAT ON (B)(6) 2022, CHEST X-RAYS CONFIRMED THAT THE ASO HAD EMBOLIZED. THE DECISION WAS MADE TO EXPLANT THE EMBOLIZED AMPLATZER SEPTAL OCCLUDER. NO OTHER REPLACEMENT DEVICE WAS IMPLANTED. THE PATIENT WAS STABLE AND DISCHARGED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218233 ↗