AMPLATZER™ 9-ASD-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067019202), received between Jun 20, 2019 and Dec 2, 2022 — classified as 1 injury, 2 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.

• MalfunctionDec 2, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 12MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION USING AN UNKNOWN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, DURING DEPLOYMENT, THE DEVICE DEFORMED INTO A COBRA SHAPE. THE DEVICE WAS REMOVED FROM PATIENT ANATOMY AND REPLACED WITH A ANOTHER 12MM AMPLATZER DUCT OCCLUDER. THE DEVICE WAS NOT RELEASED INSIDE PATIENT ANATOMY, THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM, AND THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15911127 ↗
• MalfunctionSep 20, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 12 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. WHEN THE DEVICE WAS DEPLOYED, IT DISPLAYED A COBRA HEAD APPEARANCE. THE DOCTOR THEN RECAPTURED THE DEVICE AND REMOVED IT FROM THE BODY. THE DEVICE WAS NOT RELEASED INTO THE BODY. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456741 ↗
• InjuryJun 20, 2019Migration; Migration

  ON (B)(6) 2019, A 12MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED USING ALL ON-LABEL SIZING EFFORTS INCLUDING A SIZING BALLOON UNDER TEE GUIDANCE. A TTE PERFORMED THE FOLLOWING DAY REVEALED THE DEVICE HAD EMBOLIZED. THE PATIENT WAS BROUGHT TO THE CATH LAB AND THE DEVICE WAS REMOVED FROM THE DESCENDING AORTA SUCCESSFULLY. THE USER BELIEVED THE DEVICE EMBOLIZED SECONDARY TO PATIENT ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8717539 ↗