Amplatzer™ 9-ASD-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05415067019325), received between Apr 22, 2019 and Apr 25, 2023 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (9 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 25, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION AND IT WAS ALSO REPORTED THERE WAS CONTACT WITH THE UPPER LEFT ATRIUM. IT WAS REPORTED THE PATIENT HAD A SMALL LEFT ATRIUM AND THAT THERE WERE DIFFICULTIES IN EXPANDING THE DEVICE. A DECISION WAS MADE TO REPLACE THE DEVICE WITH A SECOND UNKNOWN 28MM OCCLUDER THAT WAS IMPLANTED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. IT WAS REPORTED THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO ANGULATION/KINK NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THEIR STATUS WAS REPORTED AS STABLE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808917 ↗
• MalfunctionFeb 16, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. DURING THE PROCEDURE, THE OPERATOR NOTICED A COBRA DEFORMATION OF THE OCCLUDER. A DECISION WAS MADE TO RETRACT THE DEVICE AND ABORT THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO REPORT OF ADVERSE PATIENT EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390033 ↗
• InjuryFeb 7, 2023Poor Visibility; Poor Visibility

  IT WAS REPORTED THAT ON (B)(6) 2023, A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TORQVUE DELIVERY SHEATH. IT WAS NOTED DURING PROCEDURE THAT WHEN REMOVING THE DILATOR AND GUIDEWIRE VISIBILITY OF THE DELIVERY SHEATH WAS LOST ON THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). HOWEVER, FLUOROSCOPY WAS USED TO OBTAIN VISIBILITY. IT WAS NOTED THAT THE LEFT ATRIAL DISC OF THE 28MM AMPLATZER SEPTAL OCCLUDER HAD BEEN DEPLOYED, BUT THERE WAS STILL NO VISIBILITY NOTED ON THE TEE. IT WAS NOTED AT THIS POINT THAT THE PATIENT HAD BEGAN TO DEVELOP A PERICARDIAL EFFUSION. THE DECISION WAS MADE TO FULLY REMOVE THE 28MM AMPLATZER SEPTAL OCCLUDER AND THE 10F AMPLATZER TORQVUE DELIVERY SHEATH AND ABORTED THE IMPLANT PROCEDURE. A PERICARDIOCENTESIS WAS THEN PERFORMED TO DRAIN THE PATIENT'S PERICARDIAL EFFUSION. THE PATIENT WAS THEN EMERGENTLY SENT TO SURGERY TO ADDRESS A WOUND SUSTAINED TO THE PATIENT'S ROOF OF THE LEFT ATRIUM. IT WAS REPORTED THAT THE PATIENT HAD BEEN REMOVED FROM EXTRACORPOREAL CIRCULATION AND WAS IN STABLE CONDITION AT THE TIME OF REPORT. THERE ARE NO ALLEGATIONS OF MALFUNCTION AGAINST EITHER THE OCCLUDER OR THE DELIVERY SHEATH.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 16315888 ↗
• MalfunctionJan 10, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F NON-ABBOTT DELIVERY SHEATH. WHILE ATTEMPTING TO DEPLOY THE DEVICE INSIDE THE PATIENT, IT WAS NOTED THAT THE DEVICE WAS NOT TAKING THE PROPER SHAPE AND TOOK A COBRA-HEAD APPEARANCE. THE DEFORMED DEVICE WAS NOT RELEASED FROM DELIVERY CABLE WHILE INSIDE THE PATIENT. THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. NO REPLACEMENT DEVICE WAS IMPLANTED AND THE PROCEDURE WAS ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131047 ↗
• MalfunctionDec 8, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942167 ↗
• MalfunctionNov 21, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, DURING DEPLOYMENT, THE OCCLUDER DEFORMED INTO A COBRA SHAPE. THE OCCLUDER WAS REPLACER WITH ANOTHER 28MM AMPLATZER SEPTAL OCCLUDER AND THE DELIVERY SYSTEM WAS REPLACED WITH ANOTHER 10F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT IS REPORTED TO BE DISCHARGED. 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 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 15834388 ↗
• InjurySep 2, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 28MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED INTO THE PATIENT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. ON (B)(6) 2022, THE PATIENT PRESENTED TO THE HOSPITAL WITH SHORTNESS OF BREATH. IT WAS DISCOVERED THAT THE DEVICE WAS STILL IN PLACE IN THE ATRIAL SEPTUM, BUT THERE WAS A RESIDUAL SHUNT. THE DEVICE WAS THEN REMOVED VIA CATHETER SNARE SUCCESSFULLY. THE DEFECT WAS REMEASURED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND A 34MM SIZING BALLOON AND 24MM SIZING BALLOON. A 30MM AMPLATZER SEPTAL OCCLUDER (LOT 6693761) WAS ATTEMPTED TO BE IMPLANTED, BUT IT WAS TOO SMALL AND REMOVED FROM THE PATIENT. A 34MM AMPLATZER SEPTAL OCCLUDER (LOT 7343171) WAS ATTEMPTED TO BE IMPLANTED, BUT IT WAS TWO SMALL AND WAS REMOVED FROM THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REFERRED FOR SURGICAL CLOSURE OF THE ATRIAL SEPTAL DEFECT. THE PATIENT WAS REPORTED TO BE STABLE AND HAS SINCE BEEN DISCHARGED.

  Patient problems: Dyspnea

  MAUDE report 15349104 ↗
• MalfunctionJul 22, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6)2022, A 28MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SELECTED FOR PROCEDURE. IT WAS NOTED/CONFIRMED VIA FLUOROSCOPY EXAM THAT DURING DEPLOYMENT THE ASO EXHIBITED A COBRA DEFORMATION. IT WAS NOTED THAT DURING DEPLOYMENT THERE WAS INTERACTION WITH CARDIAC STRUCTURES. THERE WAS NO KINK OR ANGULATION NOTED IN THE DELIVERY SYSTEM. THE DECISION WAS MADE TO REPLACE THE 28MM ASO WITH AN UNKNOWN REPLACEMENT DEVICE. THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER COMPLICATIONS. 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 AND DISCHARGED AT THE TIME OF REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15082162 ↗
• MalfunctionJun 11, 2022Difficult to Fold, Unfold or Collapse; Material Protrusion/Extrusion; Difficult to Fold, Unfold or Collapse; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2022, A 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM. THERE WAS NO PROBLEM SEEN ON THE DEVICE DURING PREPARATION. DURING PROCEDURE, A DEFORMATION OF THE DEVICE WAS SEEN. THE CENTRAL PART OF THE DEVICE WAS TORN AFTER RECAPTURE AND RINSING. THERE WAS A LOOSE THREAD BETWEEN THE TWO DISCS. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT, AND NO ANGULATION OR KINK WAS NOTED IN THE DELIVERY SYSTEM. THE DEVICE WAS NOT IMPLANTED. A 30MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED INSTEAD. 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 14665520 ↗
• MalfunctionApr 20, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED A 28 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE ON (B)(6)2022. DURING DEPLOYMENT OF THE OCCLUDER, THE DEVICE PRESENTED WITH A DEFORMATION AND THE DEVICE WAS NOT PLACED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS NOTED TO HAVE BEEN DISCHARGED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14156021 ↗
• MalfunctionApr 12, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED A 28 MM AMPLATZER ATRIAL SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE ON (B)(6) 2022. DURING PROCEDURE, IN AN ATTEMPT TO DEPLOY THE DEVICE, THE LEFT ATRIAL DISC PRESENTED IN A COBRA HEAD DEFORMATION. THE DEVICE WAS NOT RELEASED FROM THE CABLE AND WAS REMOVED AND EXCHANGED FOR A NEW DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083032 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN WAS NOTIFIED OF PATIENT WITH SMALL EFFUSION ON TTE 3 WKS POST OP FOR ASD OCCLUDER DEVICE PLACEMENT. PHYSICIAN UNSURE OF CAUSE OR RELATION TO DEVICE.

  Patient problems: Pericardial Effusion

  MAUDE report 10370618 ↗
• InjuryApr 22, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2019, A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT, THE DEVICE WAS UNABLE TO BE RELEASED FROM THE DELIVERY CABLE AND THE PATIENT WAS REFERRED TO SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8538089 ↗