Amplatzer™ 9-ASD-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067019363), received between May 13, 2022 and Mar 17, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 36MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT WITH AN UNKNOWN NON-ABBOTT DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE HAD A BULBOUS DEFORMATION AND A DECISION WAS MADE TO RECAPTURE THE DEVICE AND ABORT THE PROCEDURE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. IT WAS REPORTED THERE WAS NO ANGULATION/KINK NOTICED IN THE DELIVERY SYSTEM AND THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCES AND THE PATIENT STATUS WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564179 ↗
• MalfunctionDec 29, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 36MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN AMPLATZER TORQVUE DELIVERY SYSTEM. UPON RELEASE FROM THE DELIVERY CABLE INSIDE THE PATIENT, THE DEVICE TOOK ON A COBRA DEFORMATION. IT WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER 36MM AMPLATZER SEPTAL OCCLUDER. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. 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 16069852 ↗
• MalfunctionOct 24, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 36MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE VIA FLUOROSCOPY EXAMINATION, THAT THE 36MM AMPLATZER SEPTAL OCCLUDER EXHIBITED A DEFORMATION WHEN BEING DEPLOYED. THE DEFORMED 36MM 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 AND NO KINK OR ANGULATION NOTED IN THE DELIVERY SYSTEM. THE 36MM AMPLATZER SEPTAL OCCLUDER WAS NOT DAMAGED OR MISHANDLED DURING DEVICE PREPARATION. THE DECISION WAS MADE TO REMOVE THE OCCLUDER AND ABORT THE IMPLANT PROCEDURE DUE TO THE LACK OF ANOTHER DEVICE OF THE SAME SIZE. THE PATIENT HAD 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 15659238 ↗
• MalfunctionAug 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 36MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DURING THE PROCEDURE, THE DEVICE DEPLOYED WITH A COBRA FORMATION. THE 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. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGH THE PROCEDURE AND NO CLINICAL SIGNIFICANT DELAY REPORTED. IT IS UNKNOWN IF A REPLACEMENT DEVICE WAS IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298412 ↗
• MalfunctionMay 13, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 36MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE USING A NON-ABBOTT 14FR DELIVERY SHEATH. DURING DEPLOYMENT, THE PHYSICIAN NOTED THAT THE DEVICE WAS NOT TAKING THE DESIRED SHAPE, AND A COBRA DEFORMATION WAS OBSERVED. THE DEVICE WAS RETRIEVED BACK, AND NO REPLACEMENT DEVICE WAS USED. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT, AND THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM. 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 14391155 ↗