Amplatzer™ 9-PDA2-04-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00811806011219), received between Jun 6, 2019 and Jul 13, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25808027 ↗
• MalfunctionDec 30, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924420 ↗
• 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 23729149 ↗
• MalfunctionDec 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708844 ↗
• MalfunctionMar 20, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024 A 4MM DIA 6MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR AN IMPLANT USING A NON-ABBOTT DEVICE. DURING THE PROCEDURE, WHILE DEPLOYING THE DEVICE, THE PHYSICIAN NOTED THAT THE DEVICE WAS NOT TAKING DESIRED SHAPE, IT APPEARED CORBA IN SHAPE, SO THEY HAVE TO RETRIEVE THE DEVICE BACK FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. NO DEVICE WAS ULTIMATELY IMPLANTED. THE PATIENT IS STABLE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944521 ↗
• MalfunctionApr 11, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 4/6MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR IMPLANT TO TREAT PATENT DUCTUS ARTERIOSUS (PDA) UTILIZING A 6F NON-ABBOTT DELIVERY SHEATH. DURING DEPLOYMENT IT WAS NOTED THAT THE DEVICE WAS FORMING A COBRA SHAPE, SO THE DEVICE WAS REMOVED. NO REPLACEMENT DEVICE WAS USED AND THE PROCEDURE WAS CANCELLED. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM AND THE DEVICE DID NOT INTERACT WITH ANY CARDIAC STRUCTURES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715454 ↗
• MalfunctionFeb 10, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 4MM BY 6MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANTATION USING AN UNKNOWN NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, DURING DEPLOYMENT, IT WAS NOTED THAT THE DEVICE WAS DEFORMED INTO A COBRA SHAPE. THE DEVICE WAS RETRIEVED FROM PATIENT ANATOMY AND NOT REPLACED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16357648 ↗
• MalfunctionFeb 9, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 4MM BY 6MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED A BULBOUS SHAPE OF OCCLUDER DURING THE DEPLOYMENT. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM AND NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. IT IS UNKNOWN IF A DEVICE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342201 ↗
• MalfunctionJan 16, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 4-6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. DURING PROCEDURE, THE AORTIC RETENTION DISC WITH THE CENTRAL WAIST AND THE PULMONARY RETENTION DISC "WERE NOT ALIGNING" DURING DEPLOYMENT; "BOTH DISC ARE NOT ALIGNING SYMMETRICALLY TO EACH OTHER." A NEW 5-6MM AMPLATZER DUCT OCCLUDER WAS THEN SELECTED; HOWEVER, THE SAME ISSUE OCCURRED. NO INTERACTION WITH CARDIAC STRUCTURES OCCURRED DURING DEPLOYMENT AND NO ANGULATION OR KINK WAS NOTICED WITH THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. A DELAY IN PROCEDURE WAS REPORTED WITH NO HEMODYNAMIC COMPROMISE. ULTIMATELY, A NON-ABBOTT DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16176955 ↗
• MalfunctionMar 4, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 4/6MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DURING DEPLOYMENT, THE DEVICE WAS NOT OPENING IN A DESIRED SHAPE APPEARED BULBOUS. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM AND NO INTERACTION WITH ATRIAL STRUCTURES DURING DEPLOYMENT. DEVICE WAS REPLACED WITH A NEW 4/6MM AMPLATZER DUCT OCCLUDER II THAT COMPLETED THE PROCEDURE. PATIENT STABLE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13675017 ↗
• InjuryJul 12, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON 1 JULY, 2021 A 4/6 MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR IMPLANT. POST PROCEDURE, ON (B)(6) 2021 THE DEVICE HAD EMBOLIZED. THE PATIENT WAS TAKEN FOR SURGICAL RETRIEVAL OF THE DEVICE AND SURGICAL REPAIR. THE PATIENT IS REPORTED TO BE STABLE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150957 ↗
• InjuryJun 6, 2019Positioning Problem; Positioning Problem

  ON (B)(6) 2019, A 4/6MM AMPLATZER DUCT OCCLUDER II AND A 6MM AMPLATZER MUSCULAR VSD OCCLUDER WERE SELECTED TO CLOSE AN AORTIC TO RIGHT VENTRICULAR FISTULA. WHILE ATTEMPTING TO DEPLOY BOTH DEVICES, THE PHYSICIAN REPORTED THAT BOTH DEVICES WERE UNSTABLE. THE CASE WAS ABORTED DUE TO DIFFICULTY CLOSING THE DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8677033 ↗