Amplatzer™ 9-ASD-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05415067019332), received between Dec 26, 2018 and Mar 17, 2023 — classified as 1 death, 2 injuries, 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 17 most recent of 17 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, THAT A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT WITH A NON-ABBOTT 12F DELIVERY SHEATH. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION. A DECISION WAS MADE TO RECAPTURE THE DEVICE AND ABORT THE PROCEDURE. THE DEFORMED DEVICE WAS NEVER RELEASE FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND THERE WAS NO ANGULATION/KINK NOTICED IN THE DELIVERY SYSTEM. THERE WAS NO REPORT OF ANY ADVERSE 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 16564242 ↗
• MalfunctionMar 17, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT WITH A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION AND WAS "NOT TAKING THE DESIRED SHAPE FOR DEPLOYMENT." THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY SYSTEM WHILE INSIDE THE PATIENT. A DECISION WAS MADE TO RECAPTURE THE DEVICE AND ABORT THE PROCEDURE WITH NO REPLACEMENT DEVICE. THERE WAS NO REPORT OF ANY ANGULATION/KINK NOTICED IN THE DELIVERY SYSTEM AND NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564218 ↗
• MalfunctionFeb 27, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12FR AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEPLOYMENT, THE LEFT ATRIAL DISK REMAINED COMPRESSED IN A COBRA DEFORMATION. THERE WAS INTERACTION WITH THE ATRIAL SEPTUM. THE DEFORMED OCCLUDER WAS NEVER RELEASED FROM THE CABLE. A DECISION WAS MADE TO REPLACE THE DEVICE WITH A 32MM AMPLATZER SEPTAL OCCLUDER. THE REPLACEMENT DEVICE WAS IMPLANTED IN THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF ANY ADVERSE PATIENT EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448409 ↗
• DeathDec 15, 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 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. THE OCCLUDER WAS SIZED VIA TRANS-OESOPHAGEAL ECHOCARDIOGRAM (TOE). IT WAS NOTED THAT DURING PROCEDURE THE PATIENT SUFFERED AN INTERCRANIAL HEMORRHAGE AND DIED. THE CAUSE OF THE INTERCRANIAL HEMORRHAGE IS UNKNOWN. THE PATIENT'S STATUS PRIOR TO THE IMPLANT PROCEDURE WAS STABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15988191 ↗
• MalfunctionDec 2, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. THERE WERE NO KINKS OR ANGULATION NOTICED IN THE DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE OCCLUDER DEPLOYED IN A COBRA HEADED FORMATION. THERE WAS NO DEVICE INTERACTION WITH ANY CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A REPLACEMENT NON-ABBOTT DEVICE WAS THEN CHOSEN FOR IMPLANT. THE REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15910281 ↗
• MalfunctionNov 30, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 26MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. IT WAS DETERMINED TO BE TOO SMALL. THEREFORE, THE DEVICE WAS SIZED UP TO A 30MM AMPLATZER SEPTAL OCCLUDER. WHEN IT WAS ATTEMPTED TO IMPLANT USING AN UNKNOWN DELIVERY SYSTEM, THE 30MM DEVICE DEPLOYED IN A COBRA HEADED FORMATION. IT WAS UNKNOWN IF THERE WERE ANY KINKS OR ANGULATION NOTICED IN THE DELIVERY SYSTEM. IT WAS UNKNOWN IF THE DEVICE MADE CONTACT WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEFORMED DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE BODY. THEN AN ADDITIONAL UNKNOWN DEVICE WAS CHOSEN FOR IMPLANT. THE REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884129 ↗
• MalfunctionNov 2, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED THAT DURING PROCEDURE THE OCCLUDER EXHIBITED A DEFORMATION DURING DEPLOYMENT. THE DECISION WAS MADE TO ABORT THE IMPLANT PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15718870 ↗
• MalfunctionOct 7, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE DEFORMED INTO A COBRA SHAPE, AND WAS REMOVED FROM THE PATIENT. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15568468 ↗
• MalfunctionSep 1, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE THAT THE AMPLATZER SEPTAL OCCLUDER EXHIBITED A DEFORMATION WHEN BEING DEPLOYED. THE DECISION WAS MADE TO RECAPTURE THE AMPLATZER SEPTAL OCCLUDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15341115 ↗
• MalfunctionAug 15, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANTED ON (B)(6) 2022. DURING THE PROCEDURE THE DEVICE WAS NOT TAKING PROPER SHAPE. THEREFORE, THE PHYSICIAN RETRIEVED THE DEVICE 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 NEW 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED AND IMPLANTED. THE PATIENT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229541 ↗
• MalfunctionAug 1, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM AMPLATZER SEPTAL OCCLUDER (ASO) AND A 12F AMPLATZER TORQVUE DELIVERY SYSTEM WERE SELECTED FOR PROCEDURE. DURING THE PROCEDURE THE 30MM ASO WAS NOTED TO HAVE EXHIBITED A COBRA DEFORMATION UPON DEPLOYMENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139833 ↗
• MalfunctionJul 22, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION WITH A 12F NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE IT WAS NOTED THAT THE DEVICE WAS NOT TAKING THE CORRECT SHAPE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT, AND THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED AND REPLACED WITH A 28MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081986 ↗
• MalfunctionJul 19, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SELECTED FOR PROCEDURE. DURING THE IMPLANT PROCEDURE THE 30MM ASO EXHIBITED A COBRA DEFORMATION WHEN ATTEMPTING TO DEPLOY IT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AND NO KINK OR ANGULATION NOTED IN THE DELIVERY SYSTEM. THE DECISION WAS MADE TO ABORT THE IMPLANT PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15055914 ↗
• MalfunctionMay 9, 2022Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Premature Separation; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Premature Separation

  IT WAS REPORTED A 30 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE USING AN AMPLATZER TORQVUE DELIVERY SYSTEM ON (B)(6) 2022. THERE WERE NO ISSUES DURING DEVICE PREPARATION. DURING PROCEDURE, THE DEVICE PRESENTED WITH A BULGING SHAPE AND WHEN THE USER ATTEMPTED TO REMOVE THE DEVICE, THE DEVICE DISCONNECTED FROM THE CABLE, EMBOLIZING INTO THE PATIENT'S LEFT ATRIUM. THE DEVICE DID NOT OCCLUDE THE PATIENT'S BLOOD FLOW. THE PATIENT IMMEDIATELY BECAME UNSTABLE. THE PATIENT WENT INTO CARDIAC ARREST WHILE WAITING TO TRANSFER TO CARDIAC SURGERY. DEFIBRILLATION EFFORTS WERE MADE AND WERE UNSUCCESSFUL AND THE PATIENT PASSED AWAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14333923 ↗
• InjuryApr 23, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANTED ON (B)(6) 2022 FOR AN ATRIAL SEPTAL DEFECT CLOSURE PROCEDURE. USING A 24MM UNKNOWN SIZING BALLOON, THE DEFECT WAS SIZED AT 27MM. THE 28MM OCCLUDER WAS PREPPED AND DELIVERED TO THE DEFECT. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) SHOWED SOME INSUFFICIENT APPOSITION TO THE AORTIC ROOT (AO) RIM, AND WHEN THE STABILITY TEST WAS PERFORMED, THE DEVICE PROLAPSED THRU THE DEFECT. THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. A 30MM AMPLATZER SEPTAL OCCLUDER WAS PREPPED AND DELIVERED TO THE DEFECT. ICE IMAGING SHOWED BETTER APPOSITION TO THE RIMS, WITH SOME COLOR DOPPLER FLOW NOTED THRU THE DEVICE, BUT NOT AROUND EITHER DISC. IT WAS NOTED THAT THREE SEPARATE STABILITY CHECKS WERE PERFORMED WITH EACH ONE SHOWING THE DEVICE TO BE STABLE ON THE SEPTUM. THE DEVICE WAS RELEASED FROM THE DELIVERY CABLE AND SUBSEQUENT ICE IMAGING SHOWED THE DEVICE TO BE SEATED WELL ON THE SEPTUM. THE PATIENT REMAINED STABLE AT THE POINT. TWO PRECLOSE DEVICES WERE PREPPED FOR DEPLOYMENT, AS THE FIRST PRECLOSE WAS BEING DEPLOYED, THE PATIENT BEGAN TO EXPERIENCE SOME ECTOPY, WHEN THE PATIE

  Patient problems: Air Embolism; Arrhythmia; Bradycardia; Embolism/Embolus; Stroke/CVA

  MAUDE report 14191078 ↗
• MalfunctionMar 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED, A 30MM AMPLATZER SEPTAL OCCLUDER (7023673) WAS CHOSEN FOR PROCEDURE WITH A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, UPON DEPLOYMENT OF THE DEVICE, THE LEFT DISC OF THE DEVICE PRESENTED IN A COBRA SHAPE DEFORMATION. THE DEVICE WAS RETRIEVED AND A NEW, 32MM AMPLATZER SEPTAL OCCLUDER (7170020) WAS DEPLOYED USING THE SAME DELIVERY SYSTEM. THIS DEVICE ALSO PRESENTED WITH A COBRA SHAPE DEFORMATION OF THE LEFT DISC. THE DEVICE WAS RE-SHEATHED TWICE. THE DEVICE WAS REMOVED AND EXCHANGED WITH A 34 MM AMPLATZER SEPTAL OCCLUDER (7232844). THE 34MM AMPLATZER SEPTAL OCCLUDER WAS DETERMINED A MIS-SIZING, THE DEVICE WAS TOO BIG THEREFORE NEVER IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. ULTIMATELY NO DEVICE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13911981 ↗
• InjuryDec 26, 2018Unintended Movement; Unintended Movement

  ON (B)(6) 2018, A 30MM AMPLATZER ATRIAL SEPTAL OCCLUDER (ASO) WAS SELECTED FOR USE. THE 30MM ASO WAS DEPLOYED AND RELEASED AT THE DEFECT, BUT EMBOLIZED INTO THE RIGHT ATRIUM. THE 30MM ASO WAS RETRIEVED AND A 28MM AMPLATZER ATRIAL SEPTAL OCCLUDER WAS IMPLANTED. PER USER, IMPROPER INITIAL PLACEMENT ATTRIBUTED TO THE EVENT OF EMBOLIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES AND IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196774 ↗