AMPLATZER™ 9-ASD-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05415067019165), received between Mar 25, 2022 and Apr 25, 2023 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR ATRIAL SEPTAL DEFECT IMPLANT POST MITRACLIP PROCEDURE WITH A 10F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, IT WAS NOTICED THE OCCLUDER HAD A COBRA DEFORMATION AND A DECISION WAS MADE TO REPLACE THE DEVICE WITH A 9MM AMPLATZER SEPTAL OCCLUDER. THE REPLACEMENT 9MM OCCLUDER WAS IMPLANTED IN THE PATIENT WITH NO ADVERSE PATIENT CONSEQUENCES. IT WAS REPORTED THERE WAS NO ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM, THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT, AND THERE WAS NO INTERACTION WITH ANY CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THEIR STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809939 ↗
• MalfunctionMar 14, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT WITH AN 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION. A DECISION WAS MADE TO REPLACE THE DEVICE WITH A 10MM AMPLATZER SEPTAL OCCLUDER BUT THE REPLACEMENT DEVICE ALSO HAD A COBRA DEFORMATION. IT WAS THEN DECIDED TO REMOVE THE REPLACEMENT DEVICE AND ABORT THE PROCEDURE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. IT WAS REPORTED THERE WAS INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO REPORT OF ANY 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537262 ↗
• MalfunctionMar 13, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT WITH AN 8FR AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION. IT WAS REPORTED THERE WERE FOUR ATTEMPTS MADE TO CORRECT THE CONFIGURATION BUT A DECISION WAS MADE TO RECAPTURE THE DEVICE. A REPLACEMENT 9MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED IN THE PATIENT AS A SECOND 8MM AMPLATZER SEPTAL OCCLUDER WAS NOT AVAILABLE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE, THERE WAS NO INTERACTION WITH ANY CARDIAC STRUCTURES, AND THERE WAS NO REPORT OF ANY ANGULATION/KINK WITH THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THEIR STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534860 ↗
• InjuryMar 8, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. THE NEXT DAY, IT WAS IT WAS REPORTED THAT THE DEVICE EMBOLIZED INTO THE AORTA. THE PATIENT WAS TAKEN TO SURGERY TO HAVE THE DEVICE RETRIEVED. THE DEVICE WAS SUCCESSFULLY EXPLANTED ON (B)(6) 2023. THE PATIENT WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16509177 ↗
• MalfunctionFeb 27, 2023Difficult 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 THAT ON (B)(6) 2023, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8FR AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. AFTER REPEATED ATTEMPTS TO RECAPTURE AND REDEPLOY THE DEVICE IN THE CORRECT CONFIGURATION, ONE ATTEMPT WAS MADE OUTSIDE OF THE PATIENT BEFORE BEING REINTRODUCED INTO THE PATIENT, A DECISION WAS MADE TO REPLACE THE DEVICE. A 10MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED IN THE PATIENT WITH NO REPORTED ADVERSE CONSEQUENCES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448466 ↗
• MalfunctionJan 20, 2023Difficult 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 THAT ON (B)(6) 2022, A 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT USING A 7F TREVISIO SYSTEM DELIVERY SYSTEM. DURING THE PROCEDURE THE OCCLUDER FORMED THE SHAPE OF COBRA. THE DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE AND NO DEVICE WAS ULTIMATELY IMPLANTED. NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218546 ↗
• MalfunctionJan 17, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE WAS UNABLE TO BE DEPLOYED DUE TO A COBRA HEAD DEFORMATION. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 8MM AMPLATZER SEPTAL OCCLUDER. 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 16189494 ↗
• MalfunctionDec 15, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, DURING DEPLOYMENT, IT WAS DISCOVERED THAT THE LEFT ATRIAL DISC WAS DEFORMED INTO A COBRA SHAPE. THE DEVICE WAS REMOVED FROM PATIENT ANATOMY, AND A 9MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. 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 DISCHARGED. 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 15987260 ↗
• MalfunctionOct 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. IT WAS CONFIRMED VIA A TRANSESOPHAGEAL ECHOCARDIOGRAM AND FLUOROSCOPY, THAT DURING PROCEDURE THE OCCLUDER EXHIBITED A COBRA DEFORMATION. THE 8MM AMPLATZER SEPTAL OCCLUDER WAS NOT DAMAGED OR MISHANDLED IN ANY WAY DURING DEVICE PREPARATION. THE DEFORMED OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO NOTED ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM AND NO INTERACTION WITH CARDIAC STRUCTURES AT THE TIME THE DEFORMED OCCLUDER WAS DEPLOYED. THE DECISION WAS MADE TO REMOVE THE 8MM AMPLATZER SEPTAL OCCLUDER AND REPLACE IT WITH ANOTHER ONE OF THE SAME SIZE 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 15670003 ↗
• MalfunctionSep 14, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR PROCEDURE. DURING PROCEDURE, THE AMPLATZER SEPTAL OCCLUDER EXHIBITED A COBRA DEFORMATION WHEN DEPLOYED UNDER FLUOROSCOPY. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK OBSERVED WITH THE DELIVERY SYSTEM. THE DECISION WAS MADE TO REPLACE THE AMPLATZER SEPTAL OCCLUDER WITH A NEW 8MM AMPLATZER SEPTAL OCCLUDER TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT PROLONGED PROCEDURE TIME WAS REPORTED. THE PATIENT WAS STABLE AND DISCHARGED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420027 ↗
• MalfunctionJul 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 8MM AMPLATZER SEPTAL OCCLUDER EXHIBITED A COBRA DEFORMATION DURING PROCEDURE. THE COBRA DEFORMATION WAS CONFIRMED IN THE PATIENT VIA FLUOROSCOPY EXAMINATION. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AND NO KINK OR ANGULATION NOTED IN THE NON-ABBOTT DELIVERY SHEATH. THE DECISION WAS MADE TO REPLACE THE 8MM AMPLATZER SEPTAL OCCLUDER WITH A 4MM AMPLATZER SEPTAL OCCLUDER TO COMPLETE THE PROCEDURE. BOTH THE 8MM AND 4MM AMPLATZER SEPTAL OCCLUDERS HAD BEEN SIZED USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE IMPLANT 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 15099952 ↗
• MalfunctionJun 17, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DURING DEPLOYMENT, DEVICE HAD A COBRA FORMATION AND WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE 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 SIZED, UNKNOWN DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14737442 ↗
• MalfunctionMay 20, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 8MM AMPLATZER SEPTAL OCCLUDER (7443783) WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (8287845). DURING DEPLOYMENT OF THE DEVICE IN THE LEFT ATRIUM, THE DISTAL DISC APPEARED AS A COBRA DEFORMATION. THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. THE DEVICE WAS ABLE BE REFORMED TO ITS PROPER SHAPE OUTSIDE THE BODY. THE DEVICE WAS DEPLOYED IN THE PATIENT A SECOND TIME, AND THE DEVICE TOOK A COBRA DEFORMATION AGAIN. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT, AND NO ANGULATION WAS NOTICED IN THE DELIVERY SYSTEM. THE DEVICE WAS EXCHANGED WITH A 10MM AMPLATZER SEPTAL OCCLUDER (8031289), AND THE DELIVERY SYSTEM WAS EXCHANGED WITH A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (8115344). THE REPLACEMENT DEVICE WAS 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 HAS SINCE BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459689 ↗
• MalfunctionMay 7, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD) USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE'S LEFT ATRIAL DISC DID NOT ENFOLD CORRECTLY AND TOOK A COBRA-LIKE SHAPE. THERE WAS NO ANGULATION OR KINK IN THE DELIVERY SYSTEM, AND THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEVICE WAS RECAPTURED AND REPLACED BY A 6MM AMPLATZER SEPTAL OCCLUDER WHICH WAS SUCCESSFULLY IMPLANTED, AS THERE WAS NOT ANOTHER DEVICE OF THE SAME SIZE AVAILABLE AT THE TIME. IT WAS REPORTED THAT THE PATIENT WAS STABLE AND THAT THERE WERE NO ADVERSE HEALTH CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14313851 ↗
• MalfunctionMar 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  ON (B)(6) 2022, A 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT, THE LEFT ATRIAL DISC APPEARED IN COBRA-LIKE DEFORMATION. THE DEVICE WAS RESHEATHED AND REMOVED FROM THE PATIENT AND EXCHANGED WITH A NEW 10MM AMPLATZER SEPTAL OCCLUDER WHICH WAS SUCCESSFULLY IMPLANTED. THERE WAS NO ANATOMICAL INTERFERENCE NOTED DURING DEVICE DEPLOYMENT. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905132 ↗