Amplatzer™ 9-PDA2-05-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00811806011233), received between May 13, 2022 and Apr 10, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, 5MM-4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE DEVICE'S DISCS WAS NOT OPENING PROPERLY & THERE WAS A BULBOUS DEFORMATION NOTICED IN THE AORTA. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PROCEDURE GOT ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845348 ↗
• MalfunctionJan 14, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 5-4MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR IMPLANT USING A 5F AMPLATZER TORQVUE LP DELIVERY SYSTEM. DURING THE PROCEDURE IT WAS OBSERVED THAT THE DEVICE DID NOT CONFORM TO ITS DESIRED SHAPE FROM THE BEGINING, IT CONFORMED INTO BULBOUS DEFORMATION. THE PROCEDURE WAS COMPLETED USING A NEW 5-4MM AMPLATZER DUCT OCCLUDER II. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT, AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. 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 24074936 ↗
• MalfunctionDec 29, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918037 ↗
• MalfunctionAug 14, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025, A 5MM X 4MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANT USING A 5F AMPLATZER TORQVUE LOW PROFILE CATHETER TO TREAT A PATENT DUCTUS ARTERIOSUS (PDA). DURING THE PROCEDURE THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY CATHETER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS TO THE PROCEDURE. THERE WERE NO ADVERSE SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806669 ↗
• MalfunctionJun 18, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 5-4MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANT USING A 5F NON-ABBOTT SHEATH. DURING IMPLANT, WHILE DEPLOYING, THE OCCLUDER DEFORMED INTO A COBRA SHAPE AND WAS RETRACTED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. ULTIMATELY, NO DEVICE WAS IMPLANTED AT THIS TIME. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558749 ↗
• MalfunctionMar 29, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5MM BY 4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM. WHILE ATTEMPTING TO IMPLANT THE DEVICE, THE HEALTH CARE PROFESSIONAL DEPLOYED THE DEVICE, BUT THE RIGHT DISC COULD NOT BE RELEASED AND DEPLOYED IN A COBRA SHAPE. THE DEVICE WAS FOUND TO BE DEFECTIVE. THERE WAS NO NOTED INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEFORMED DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. NO REPLACEMENT DEVICE INFORMATION WAS PROVIDED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639611 ↗
• MalfunctionMay 13, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED A 5/4 MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR PROCEDURE ON (B)(6) 2022. DURING AN ATTEMPT TO DEPLOY THE DEVICE IN THE PATIENT, THE DEVICE PRESENTED WITH A DEFORMATION, AN UNINTENDED SHAPE. THE USER REMOVED THE DEVICE AND EXCHANGED THE DEVICE WITH A NEW, 5/4 MM AMPLATZER DUCT OCCLUDER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 14391536 ↗