AMPLATZER™ 9-ASD-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05415067019172), received between Jun 6, 2019 and May 4, 2023 — classified as 1 injury, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, THREE AMPLATZER SEPTAL OCCLUDERS WAS CHOSEN FOR IMPLANT WITH A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (ATV). DURING PROCEDURE, ALL THE AMPLATZER SEPTAL OCCLUDERS HAD A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. A DECISION WAS MADE TO REPLACE THE TREVISIO DELIVERY SYSTEM WITH A UNKNOWN ABBOTT DEVICE AND COMPLETED THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND HEALTH IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868568 ↗
• MalfunctionApr 13, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT TO TREAT AN ATRIAL SEPTAL DEFECT UTILIZING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE LEFT ATRIAL DISC OF THE OCCLUDER DID NOT TAKE THE DESIRED SHAPE, IT INSTEAD HAD A BULBOUS SHAPE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED AND A REPLACEMENT 11MM AMPLATZER SEPTAL OCCLUDER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16737339 ↗
• MalfunctionMar 14, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT WITH AN 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A DECISION WAS MADE TO REPLACE THE DEVICE WITH AN 8MM AMPLATZER SEPTAL OCCLUDER. THE REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT WITH NO ADVERSE PATIENT EFFECTS. THERE WAS NO REPORT OF INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND THERE WAS NO ANGULATION/KINK NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541630 ↗
• MalfunctionFeb 13, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE WAS DEFORMED AND APPEARED COBRA IN SHAPE. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM AND NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. DEVICE WAS REPLACED WITH 16MM AMPLATZER SEPTAL OCCLUDER THAT WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364331 ↗
• MalfunctionDec 22, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION. DURING THE PROCEDURE, DURING DEPLOYMENT, IT WAS NOTED THAT THE DEVICE DEFORMED INTO A COBRA SHAPE. THE DEVICE WAS REMOVED FROM PATIENT ANATOMY AND REPLACED WITH ANOTHER 9MM AMPLATZER SEPTAL OCCLUDER. THE DEVICE WAS NOT RELEASED INSIDE PATIENT ANATOMY, THERE WAS NO REPORTED ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM, AND THERE WAS NO REPORTED INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. 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 16037390 ↗
• MalfunctionAug 5, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANTED ON (B)(6) 2022. DURING THE PROCEDURE THE OCCLUDER DEVELOPED A COBRA HEAD DEFORMITY, THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. A NEW 9MM AMPLATZER SEPTAL OCCLUDER NO ISSUES WITH THE SECOND DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15179697 ↗
• MalfunctionJul 14, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DURING THE PROCEDURE THE DEVICE CAME OUT OF THE SHEATH IN COBRA SHAPE; DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM AND NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. A 10MM AMPLATZER SEPTAL OCCLUDER WAS USED TO FINISH THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15018481 ↗
• MalfunctionJun 17, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE ON (B)(6)2022 USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE OCCLUDER PASSED THE INITIAL INSPECTION DURING DEVICE PREPARATION. DURING THE FIRST ATTEMPT AT DEPLOYMENT, THE OCCLUDER PRESENTED WITH A COBRA SHAPED DEFORMATION. THE DEVICE WAS REMOVED PRIOR TO RELEASE FROM THE DELIVERY CABLE. A NEW 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED AND SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS NOTED TO HAVE BEEN DISCHARGED AT THE TIME OF REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14735330 ↗
• MalfunctionJun 2, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT ON (B)(6) 2022. DURING PROCEDURE, THE DEVICE WAS DELIVERED IN THE PATIENT USING A 7FR AMPLATZER TORQVUE DELIVERY SYSTEM. UPON DEPLOYMENT, THE LEFT ATRIAL DISC PRESENTED WITH A COBRA DEFORMATION. THE DEVICE WAS RE-SHEATHED AND REMOVED. THE DEVICE WAS RE-SHEATHED AND TESTED OUTSIDE THE PATIENT AND THE DEFORMITY REMAINED. THE DEVICE WAS NOT USED AND EXCHANGED WITH A NON-ABBOTT DEVICE. 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 14580281 ↗
• MalfunctionMay 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 9MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SELECTED FOR A IMPLANTED ON (B)(6) 2022. DURING DEPLOYMENT, DEVICE DEFORMED INTO COBRA-HEADED AND WOULD NOT GO BACK INTO THE AMPLATZER TREVISIO DELIVERY SYSTEM; THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. AN UNKNOWN DEVICE WAS ULTIMATELY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14493781 ↗
• InjuryJun 6, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2019, A 9MM AMPLATZER SEPTAL OCCLUDER (ASO), 10MM ASO AND A 14MM ASO WERE SELECTED TO CLOSE A PSEUDOANEURYSM (PSA) IN A PATIENT DIAGNOSED WITH AN AORTIC DISSECTION ALONG THE ENTIRE LENGTH OF THE AORTA AND AN ASCENDING AORTIC PSEUDOANEURYSM. AFTER ATTEMPTING TO IMPLANT ALL THREE DEVICES, THE ASOS WERE REPORTED TO HAVE DISLOCATED. AFTER THE 14MM ASO DISLOCATED, THE DEVICE WAS EXCHANGED FOR THE ORIGINAL 9MM ASO. THREE MINUTES FOLLOWING IMPLANT, THE DEVICE EMBOLIZED TO THE FALSE LUMEN OF THE DESCENDING AORTA WITH NO IMPACT TO THE PATIENT STATUS. NO IMMEDIATE ATTEMPT WAS MADE TO RETRIEVE THE EMBOLIZED ASO SINCE THERE WAS NO IMPACT ON AORTIC FLOW. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS TRANSFERRED TO SURGERY TO REPAIR THE PSA, AORTIC DISSECTION AND POSSIBLE REMOVAL OF THE ASO. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8677043 ↗