Amplatzer™ Septal Occluder (REF 9-ASD-011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00811806010083), received between Jun 30, 2020 and Sep 15, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 11 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING 7 F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, A COBRA DEFORMATION WAS NOTED. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WERE NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE OBSERVED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS THEN COMPLETED USING A 12MM AMPLATZER SEPTAL OCCLUDER. IT WAS REPORTED THAT THE PATIENT IS HEMODYNAMICALLY STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059851 ↗
• MalfunctionJul 8, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 11MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT, THE OCCLUDER FORMED A COBRA DEFORMATION. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE AND WAS NOT IMPLANTED. A NEW 10MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440739 ↗
• MalfunctionJun 27, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 11MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE DEFORMED WITH A COBRA SHAPE AND WAS NOT IMPLANTED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND REMOVED. THE DEFECT WAS SURGICALLY CLOSED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350565 ↗
• MalfunctionJun 27, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 11MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING AN UNKNOWN DELIVERY SYSTEM. THE 20MM DEFECT WAS TOO CLOSE TO THE AORTA, SO THAT WHEN ATTEMPTING TO PLACE, THE LEFT ATRIAL DISC CONTACTED THE AORTA. SINCE THERE WAS A SMALL LEFT ATRIAL SPACE RELATIVE TO A 20 MM DEFECT, IT WAS IMPOSSIBLE TO PLACE A 20 MM OCCLUDER, RESULTING IN A COBRA HEAD CONFIGURATION. SINCE THIS POSED A RISK FOR DEVICE EROSION, THE DEVICE WAS NEVER RELEASED AND WAS REMOVED FROM THE PATIENT. DUE TO THE DIFFICULTY PLACING THE DEVICE, THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345617 ↗
• InjuryJul 19, 2024Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2024, AN 11MM AMPLATZER ATRIAL SEPTAL DEFECT (ASD) OCCLUDER (LOT: 8025259) WAS IMPLANTED SUCCESSFULLY UTILIZING AN 8F AMPLATZER TREVISIO DELIVERY SYSTEM. THE SIZE OF THE ASD WAS 6MM PER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PATIENT WAS EXPERIENCING SHORT TERM DISCOMFORT WHILE RUNNING. ON (B)(6) 2024, DURING A FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), THE OCCLUDER WAS OBSERVED TO BE DETACHED AND LOCATED IN THE ABDOMINAL AORTA. THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2024 THE OCCLUDER WAS REMOVED FROM PATIENT USING A TRANSCATHETER SNARE. THE PATIENT WAS REPORTED TO BE STABLE AND DISCHARGED.

  Patient problems: Embolism/Embolus

  MAUDE report 19784428 ↗
• MalfunctionJun 21, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 03 JUNE 2024, A 11 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, LEFT ATRIAL DISC BECAME A SHAPE OF COBRA HEAD WHEN THE DEVICE WAS DEPLOYED, AND IT WAS UNABLE TO BE RE-SHAPED. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. THE LEFT ATRIUM MADE SLIGHT CONTACT WITH TISSUE ABOVE. NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE DEVICE WAS DISCARDED. THE PROCEDURE WAS POSTPONED SINCE THE SAME SIZE DEVICE WAS OUT OF STOCK IN THE FACILITY. NO ADVERSE PATIENT CONSEQUENCES ARE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19586445 ↗
• InjuryOct 11, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 11MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A AMPLATZER TREVISIO DELIVERY SYSTEM. DURING IMPLANTATION, THE OCCLUDER COULD NOT BE RECAPTURED BY THE DELIVERY SHEATH. TWO OTHER DELIVERY SYSTEMS WERE USED TO ATTEMPT RECAPTURE BUT FAILED. THE PATIENT WAS THEN SENT TO SURGERY TO HAVE THE OCCLUDER EXPLANTED AND THE ASD REPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913809 ↗
• MalfunctionFeb 24, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 11MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED AS USUAL WITH USE OF A 7F AMPLATZER TREVISIO DELIVERY SYSTEM. THE PHYSICIAN DID NOT ENCOUNTER ANY DIFFICULTY OR RESISTANCE WITH THE DEVICE IMPLANT. AFTER THE ASO WAS IMPLANTED IN THE DEFECT, THE DELIVERY CABLE WAS DETACHED FROM THE ASO WITHOUT ANY ISSUE. WHEN THE DELIVERY CABLE WAS BEING PULLED INTO THE TREVISIO DELIVERY SHEATH, RESISTANCE WAS FELT. AFTER PULLING OUT FROM THE PATIENT, FIBROUS FORM LIKE SUBSTANCES WAS VISUALLY CONFIRMED ADHERING ONTO 1-2CM OF THE TIP OF THE DELIVERY CABLE. THE PHYSICIAN ALLEGED THAT ALTHOUGH THE ASO WAS ABLE TO BE DETACHED FROM THE DELIVERY CABLE AS USUAL, RESISTANCE WAS FELT WHILE THE DELIVERY CABLE WAS PULLED INTO THE DELIVERY SHEATH. SO THE POLYESTER FIBER MIGHT HAVE BEEN ACCIDENTALLY TANGLED BY THE CABLE. AT PRESENT, NO FINDINGS HAVE BEEN CONFIRMED UNDER ECHO OBSERVATION AND FLUOROSCOPY OF THE ASO AFTER PLACEMENT. THE PRODUCT BOX CONTAINING THE DELIVERY SYSTEM DID NOT APPEARED DAMAGED IN ANY WAY. PATIENT STABLE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436151 ↗
• InjuryJan 27, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2021, A 11MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. ON (B)(6) 2021, THE DEVICE EMBOLIZED INTO THE AORTA. THE DEVICE WAS REMOVED USING A SNARE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11236805 ↗
• InjuryJun 30, 2020Biocompatibility; Biocompatibility

  ON (B)(6) 2020, AN 11MM AMPLATZER SEPTAL OCCLUDER(ASO) WAS IMPLANTED IN THE PATIENT'S DEFECT. LATE IN (B)(6) 2020, ATYPICAL GENITAL BLEEDING OCCURRED ON THE PATIENT, AND ASPIRIN WHICH HAD BEEN PRESCRIBED TO THE PATIENT FOR ABOUT THREE MONTH WAS STOPPED. THE CAUSE OF THE BLEEDING WAS GYNECOLOGIC MALIGNANT TUMOR, AND CHEMOTHERAPY WAS STARTED ON THE PATIENT. ON (B)(6) 2020, CONTRAST-ENHANCED CT WAS OBTAINED ON THE PATIENT, THEN A LARGE THROMBUS WAS INCIDENTALLY FOUND ON THE LA DISK SIDE OF THE ASO. DABIGATRAN ETEXILATE HAS CONTINUOUSLY BEEN PRESCRIBED ON THE PATIENT, BUT THE PHYSICIAN THOUGHT IT WAS INSUFFICIENT, AND CHANGED IT TO HEPARIN IV. THE PATIENT'S CURRENT STATE AND THE LOT# ARE CONFIRMING.

  Patient problems: Intermenstrual Bleeding; Thrombus

  MAUDE report 10211636 ↗