Amplatzer™ 9-ASD-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05415067019288), received between Apr 2, 2022 and Apr 10, 2023 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT WITH A NON-ABBOTT DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION AND WAS "NOT TAKING THE PROPER SHAPE." A DECISION WAS MADE TO RECAPTURE THE DEVICE AND ABORT THE PROCEDURE WITH NO REPLACEMENT DEVICE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT DURING DEPLOYMENT. THERE WAS NO INTERACTION WITH ANY CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK NOTICED IN THE DELIVERY SYSTEM. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCES, 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 16709487 ↗
• MalfunctionMar 23, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THERE WAS SOME COBRA FORMATION. 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 CARDIAC STRUCTURES DURING DEPLOYMENT. A NEW 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED AND IMPLANTED SUCCESSFULLY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16599247 ↗
• MalfunctionFeb 27, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN UNKNOWN SIZE AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE THAT THE LEFT ATRIAL DISC OF THE OCCLUDER EXHIBITED A COBRA DEFORMATION WHEN BEING DEPLOYED. THE DECISION WAS MADE TO REMOVE THE OCCLUDER AND AGAIN, PREPARE THE OCCLUDER FOR IMPLANT. HOWEVER, WHEN DEPLOYING THE OCCLUDER A SECOND TIME IT WAS NOTED THAT THE DEFORMATION PERSISTED. THE DECISION WAS MADE TO REMOVE AND REPLACE THE 20MM AMPLATZER SEPTAL OCCLUDER WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448959 ↗
• MalfunctionFeb 22, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND THERE WAS NO ANGULATION/KINK NOTICED IN THE DELIVERY SYSTEM. IT WAS REPORTED THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417874 ↗
• MalfunctionNov 28, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT INTO AN ATRIAL SEPTAL DEFECT. UPON DEPLOYMENT THE OCCLUDER EXPERIENCED A COBRA DEFORMATION. THERE WERE MULTIPLE ATTEMPTS TO REDEPLOY BUT THE RESULTS WERE UNCHANGED. THE DEVICE WAS REPLACED WITH ANOTHER AMPLATZER SEPTAL OCCLUDER OF THE SAME SIZE AND THE PROCEDURE CONCLUDED WITHOUT ANY FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874162 ↗
• MalfunctionNov 15, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 20MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SELECTED FOR IMPLANT USING AN UNKNOWN SIZE ABBOTT DELIVERY SYSTEM. ON THE FIRST ATTEMPT TO PLACE THE OCCLUDER IN THE PATIENT'S ATRIAL SEPTAL DEFECT, THE DEVICE NEEDED TO BE REPOSITIONED. ON THE SECOND DEPLOYMENT ATTEMPT, THE DEVICE DEPLOYED IN A COBRA-HEADED DEFORMATION. IT WAS THEN RECAPTURED, REMOVED FROM THE BODY AND RETESTED. WHEN IT WAS OUTSIDE THE BODY, IT RETURNED TO ITS ORIGINAL, NON-DEFORMED SHAPE. THE SAME ASO WAS ATTEMPTED TO DEPLOY AGAIN, BUT IT DEFORMED TO A COBRA-HEADED POSTURE AGAIN. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY SYSTEM WHILE IT WAS INSIDE THE BODY. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND DISCARDED. A REPLACEMENT DEVICE WAS NOT IMPLANTED. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799428 ↗
• MalfunctionNov 4, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE VIA TRANSESOPHAGEAL ECHOCARDIOGRAM AND FLUOROSCOPY, THAT THE OCCLUDER EXHIBITED A DEFORMATION OF THE RIGHT ATRIAL DISC WHEN BEING DEPLOYED. THE 20MM AMPLATZER SEPTAL OCCLUDER WAS NOT DAMAGED OR MISHANDLED IN ANY WAY DURING DEVICE PREPARATION. THE DEFORMED 20MM AMPLATZER SEPTAL OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT OF THE OCCLUDER. THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM. THE DECISION WAS MADE TO REMOVE THE 20MM AMPLATZER SEPTAL OCCLUDER AND REPLACE IT WITH A 20MM NON-ABBOTT DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724577 ↗
• InjuryOct 26, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. IT WAS CONFIRMED VIA AN ECHOCARDIOGRAM, THAT THE OCCLUDER HAD EMBOLIZED IN THE PATIENT AFTER IT'S FULL DEPLOYMENT. THE PATIENT WAS SENT TO SURGERY TO EXPLANT THE EMBOLIZED OCCLUDER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15675801 ↗
• MalfunctionOct 14, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE REPEATEDLY DEFORMED INTO A COBRA SHAPE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED FROM PATIENT ANATOMY AND REPLACED WITH ANOTHER 20MM AMPLATZER SEPTAL OCCLUDER TO COMPLETE THE PROCEDURE. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611295 ↗
• MalfunctionJul 18, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE LEFT ATRIAL DISC WAS DEPLOYED BUT DEFORMED INTO A COBRA SHAPE. THERE WAS NO ANGULATION NOR KINK IN THE DELIVERY SYSTEM, AND NO INTERACTION WITH PATIENT CARDIAC STRUCTURES. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 20MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS STABLE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048298 ↗
• MalfunctionJun 20, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DURING DEPLOYMENT OF DEVICE, PHYSICIAN NOTED THAT IT WAS NOT TAKING DESIRED SHAPE AND THE DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. NO DEVICE WAS ULTIMATELY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14750442 ↗
• MalfunctionMay 10, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING RELEASE, THE DEVICE ASSUMED A NON-CONFORMING COBRA SHAPED DEFORMATION. THE DEVICE WAS RECAPTURED IN THE INTRODUCER AND TAKEN OUT OF THE PATIENT. OUTSIDE OF THE PATIENT, THE DEVICE ASSUMED THE SAME COBRA SHAPE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE DECISION WAS MADE TO REPLACE THE DEVICE WITH A 22MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. 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 14344766 ↗
• InjuryApr 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 20MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED WITHOUT DIFFICULTY, AND THE PROCEDURE WENT WELL. AFTER THE PROCEDURE WHEN THE PATIENT WOKE UP, THEY COMPLAINED OF CHEST PAIN. ACETAMINOPHEN WAS GIVEN FOR PAIN. ON (B)(6) 2022, AN ECHOCARDIOGRAM WAS PERFORMED AND A SMALL PERICARDIAL EFFUSION WAS OBSERVED. ON (B)(6) 2022, AN ECHOCARDIOGRAM SHOWED THAT THE EFFUSION WAS REDUCING, AND THE IMPLANT WAS WELL IN PLACE. ON (B)(6) 2022, THE PHYSICIAN SUGGESTED THAT PAIN COULD HAVE VERTEBRAL ORIGIN, AND AN ECHOCARDIOGRAM SHOWED THAT THE SMALL PERICARDIAL EFFUSION HAD DECREASED BUT WAS STILL PRESENT. ON (B)(6) 2022, THERE WAS NO EVOLUTION ON ECHOCARDIOGRAM. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED HOME. THE EVENT REQUIRED PROLONGED HOSPITALIZATION.

  Patient problems: Pericardial Effusion

  MAUDE report 13988785 ↗