Amplatzer™ 9-PDA2-03-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00811806011172), received between Jul 13, 2021 and Dec 11, 2025 — classified as 1 injury, 4 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 18, 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.

• MalfunctionDec 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON AN UNKNOWN DATE, A 3-4MM AMPLAZTER ADO II WAS CHOSEN FOR IMPLANT USING AN 4F TVLP DELIVERY SYSTEM. IT WAS NOTED THAT THE DEVICE WAS NOT CONFORMING TO ITS DESIRED SHAPE AND TOOK FORM OF A BULBOUS DEFORMATION. 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 PROCEDURE WAS ABORTED. 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 23784592 ↗
• MalfunctionApr 9, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 3-4MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR IMPLANT USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM. DURING PROCEDURE, THE OCCLUDER HAD A COBRA DEFORMATION. 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. A NEW 4-4MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19073106 ↗
• MalfunctionJun 25, 2022Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  IT WAS REPORTED A 3MM-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2022. DURING THE PROCEDURE, DIFFICULTY WAS NOTED IMPLANTING THE DEVICE INTO POSITION. THE DEVICE WAS RE-SHEATHED AND DEPLOYED 5 TO 6 TIMES. ULTIMATELY THE DEVICE PRESENTED WITH DEFORMATION. THE DEVICE WAS REMOVED AND EXCHANGED WITH A NEW 3MM-4MM AMPLATZER DUCT OCCLUDER, THAT WAS SUCCESSFULLY IMPLANTED. IT WAS NOTED THAT THE DIFFICULTY WITH IMPLANT WAS DUE TO THE SHEATH ANGLE AND THE PATENT DUCTUS ARTERIOSUS (PDA) ANATOMY. 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 14819751 ↗
• MalfunctionApr 24, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, AN AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT IN A PATENT DUCTUS ARTERIOSUS (PDA) USING A 5F NON-ABBOTT GUIDE CATHETER. THE DEVICE WAS DEPLOYED IN A SMALL TUBULAR PDA WITH 2.5MM DIAMETER AND 5MM LENGTH. THE DEVICE WAS NAVIGATED THROUGH THE DELIVERY SYSTEM, BUT THE PROXIMAL DISC OF THE DEVICE WAS NOT ABLE TO OPEN PROPERLY ON DEPLOYMENT. THE DEVICE WAS SHOWING INCOMPLETE EXPANSION OF THE DISC. THERE WAS NO ANGULATION IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THE CASE WAS ABANDONED, AND THE PATIENT WAS DISCHARGED THE NEXT DAY. 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 14191131 ↗
• InjuryJul 13, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, A 3MM/4MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANT FOR THE PATIENT'S PATENT DUCTUS ARTERIOSUS (PDA). THE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE PDA, BUT IMMEDIATELY AFTER THE DEVICE WAS DETACHED FROM THE DELIVERY CABLE, THE OCCLUDER DISLODGED TO THE PULMONARY ARTERY SIDE WITHOUT CAUSING A BLOCKAGE. THE DEVICE WAS REMOVED FROM THE PATIENT PERCUTANEOUSLY USING A SNARE CATHETER (GOOSE NECK), WHICH TOOK APPROXIMATELY 30 MINUTES. AFTER THE DEVICE WAS SUCCESSFULLY REMOVED, THE IMPLANT PROCEDURE WAS ABANDONED AND THERE WAS NO REPLACEMENT DEVICE. THE TREATMENT FOR THE PATIENT WILL BE RECONSIDERED ON A LATER DATE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. ACCORDING TO THE PHYSICIAN, THE DEVICE WAS CHOSEN APPROPRIATELY BASED ON MORPHOLOGICAL EVALUATION OF THE PDA BASED ON COMPUTERIZED TOMOGRAPHY (CT) AND ANGIOGRAPHY IMAGING, THEREFORE THE DEVICE DISLODGEMENT WAS RELATED TO THE PROCEDURE AND THE PATIENT'S ANATOMY. NO ALLEGATION TO THE SIZING OF THE DEVICE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body Embolism

  MAUDE report 12162914 ↗