Amplatzer™ 9-PDA2-04-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00811806011202), received between Jun 29, 2023 and Feb 19, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390219 ↗
• MalfunctionDec 23, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 04- 04 AMPLATZER ADOII WAS CHOSEN FOR IMPLANT USING AN 4F AMPLATZER TVLP DELIVERY SYSTEM. IT WAS OBSERVED THAT THE DEVICE EMBOLIZATION WAS NOTED DURING THE PROCEDURE. 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 23881824 ↗
• MalfunctionDec 5, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726883 ↗
• MalfunctionNov 7, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 4MM-4MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN TO TREAT PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECT (PMVSD), UTILIZING 5F NON-ABBOTT GUIDE CATHETER. DURING DEPLOYMENT, THE DISTAL DISC WAS NOTED TO DEFORM TO A COBRA-LIKE SHAPE. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PROCEDURE WAS ABORTED WITH NO IMPLANTED DEVICE IMPLANT. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THIS ISSUE REPORTEDLY CAUSED A CLINICALLY SIGNIFICANT DELAY, BUT THE DELAY DID NOT RESULT IN ADVERSE PATIENT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18086488 ↗
• MalfunctionJun 29, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 4MM-4MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN TO TREAT VENTRICULAR SEPTAL DEFECT (VSD), USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE LEFT DISC DEFORMED. THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. IT WAS DECIDED TO ABORT THE PROCEDURE. THE PATIENT WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225017 ↗