Amplatzer™ 9-ASD-MF-018Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00811806010281), received between Sep 13, 2019 and Nov 17, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8MM AMPLATZER SEPTAL OCCLUDER AND 18MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT FOR ATRIAL SEPTAL DEFECT SEQUENTIALLY USING A 8F AMPLATZER TREVISIO DELIVERY SYSTEM. THE DEFECT SIZE WAS MEASURED USING AN INTRACARDIAC ECHOCARDIOGRAPHY(ICE) CATHETER. DURING THE PROCEDURE, WHEN THE DEVICE WAS EXPANDING INSIDE THE PATIENT, THE OCCLUDER DEFORMED INTO A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. IT WAS NOTED THAT CONTACTS OCCURRED WITH INTRACARDIAC TISSUE DURING THE OCCLUDER DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING A 25MM AMPLATZER CRIBRIFORM OCCLUDER. 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 23571139 ↗
• MalfunctionJan 10, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, AN 18MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, EXCESSIVE SEPARATION BETWEEN THE DISCS AND A BULGING LEFT ATRIAL DISC WAS OBSERVED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVER SYSTEM. THE OCCLUDE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND IT WAS EXCHANGED FOR A NEW 28MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124179 ↗
• InjuryJun 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, ¿TREATMENT EXPERIENCE OF PERCUTANEOUS EMBOLIZATION USING MULTIPLE-CLOSURE EMBOLIZATION FOR POROUS ATRIAL SEPTAL DEFECT (MASD)¿, WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A BACKGROUND OF PERCUTANEOUS EMBOLIZATION FOR POROUS ATRIAL SEPTAL DEFECT (MASD), THE NUMBER OF OBTURATOR PLUGS, CLOSING PLUGS SELECTION, AND THE PLACEMENT PROCEDURES TREATMENT REQUIRED FOR EACH INDIVIDUAL. THE PURPOSE IS TO REPORT MASD TREATMENT EXPERIENCE USING MULTIPLE-CLOSURE PLUGS IN OUR HOSPITAL AND TO INVESTIGATE THE FACTORS THAT INFLUENCED CLOSURE PLUG SELECTION. CASES WERE REVIEWED RETROSPECTIVELY TO INVESTIGATE THE NUMBER OF DEFECT HOLES, SIZE, DISTANCE BETWEEN HOLES, INDWELLING CLOSURE PLUG, RELATIONSHIP WITH SURROUNDING STRUCTURES, AND PRESENCE OF RESIDUAL SHUNT. [CASE 2]. A 7-YEAR-OLD GIRL. A MESH-SHAPED DEFECT HOLE CONTAINING AN ACCESSORY HOLE WITH AN INTERFORAMINAL DISTANCE OF 6MM, 3MM POSTERIOR TO THE MAIN FORAMEN OF 7MM. FIRST, AN AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER CASO-MF) 18MM WAS PLACED IN THE ACCESSORY FORAMEN, RESULTING IN A SMALL AMOUNT OF RESIDUAL SHUNT, AND A ASO 6MM WAS PLACED IN THE MAIN FORAMEN. RESIDUAL SHUNT TRIVIAL WITHOUT INTERFERING WITH SURROUNDING TISSUE. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14690235 ↗
• MalfunctionJul 27, 2021Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT A 9F NON-ABBOTT DELIVERY SYSTEM WAS USED FOR THE IMPLANT PROCEDURE. THE DELIVERY SYSTEM WAS 1 SIZE LARGER THAN IS RECOMMENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233121 ↗
• InjuryMar 11, 2021Retraction Problem; Material Deformation; Retraction Problem; Material Deformation

  ON (B)(6) 2021, A 18MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. DURING PLACEMENT, IT WAS DEEMED TOO SMALL. WHILE ATTEMPTING TO RE SHEATH THE 18MM AMPLATZER CRIBRIFORM OCCLUDER THE DEVICE WOULD NOT ENTER DESPITE STRONG FORCE. IT WAS THOUGHT THAT THE DISTAL TIP OF THE AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM SHEATH SOMEHOW FOLDED-IN ON ITSELF CAUSING ISSUES WITH RETRIEVING THE DEVICE. THE HOSPITAL HAD NO EXCHANGE DELIVERY SYSTEM SO THE PHYSICIAN CUT THE TAPERED END OF THE DILATOR IN ORDER TO PASS IT OVER THE DELIVERY CABLE AND STRAIGHTEN THE DISTAL TIP OF THE SHEATH, HOWEVER, THEY COULD NOT GET THE CUT DILATOR OVER THE DELIVERY CABLE. IT WAS THEN DECIDED TO USE A 6F DELIVERY SHEATH TO PUSH OUT THE TIP OF THE 9F DELIVERY SHEATH. THE 9F SHEATH WAS CUT TO REMOVE ENOUGH OF THE PROXIMAL END TO ALLOW THE 6F SHEATH TO REACH THE END. THIS STRATEGY WORKED AND THE DEVICE WAS RECAPTURED WITHOUT ISSUE. THE DEVICE WAS INSPECTED AND PROFILE THE RIGHT DISC APPEARED OVAL INSTEAD OF FLATTENED. A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PROCEDURE WAS SIGNIFICANTLY DELAYED BECAUSE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11466324 ↗
• InjurySep 13, 2019Material Deformation; Material Deformation

  ON (B)(6) 2019, AN 18 MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR USE. WHEN THE 18 MM ACO WAS DEPLOYED AT THE ATRIAL SEPTAL DEFECT, THE RA DISK WAS NOT ABLE TO FULLY SPREAD. THE ACO WAS REPLACED WITH THE SAME SIZE OF ACO AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9034816 ↗