Amplatzer™ Septal Occluder (REF 9-ASD-007)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00811806010045), received between Jun 18, 2019 and Jan 2, 2026 — classified as 2 injuries, 8 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.

• MalfunctionJan 2, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950739 ↗
• MalfunctionJul 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT AS REPORTED THAT ON (B)(6) 2025, A 7MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, IMMEDIATELY AFTER DEPLOYMENT IN THE LEFT ATRIUM THE DEVICE HAD A COBRA DEFORMATION. THE DEFORMED OCCLUDER WAS RETRIEVED OUTSIDE THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE INSIDE THE PATIENT. THERE WAS NO CONTACTS OCCURRED WITH INTRACARDIAC TISSUE DURING THE OCCLUDER DEPLOYMENT. THERE WERE NO BENDS OR KINKS BEEN OBSERVED IN THE DELIVERY SHEATH. A NEW 7MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE USING THE SAME DELIVERY SYSTEM. THERE WAS NO ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394533 ↗
• MalfunctionJul 16, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON(B)(6) 2024, A 7MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN UNKNOWN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE THE DEVICE WAS BEING DEPLOYED, IT PRESENTED IN A COBRA DEFORMATION. THERE WERE SEVERAL ATTEMPTS MADE TO TRY TO CORRECT IT, BUT THE DEFORMATION REMAINED. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE, REMOVED, AND REPLACED WITH A 8MM AMPLATZER SEPTAL OCCLUDER WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WERE NO ADVERSE EVENTS. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES OR ANGULATION/KINK IN THE DELIVERY SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750715 ↗
• MalfunctionJun 12, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 7MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING IMPLANT, THE OCCLUDER DEFORMED WITH A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WAS NO ANGULATION OR KINK OBSERVED WITH THE DELIVERY SYSTEM. A NEW 8MM 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 19520032 ↗
• MalfunctionDec 6, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 7MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2023 USING AN 8F AMPLATZER TALISMAN DELIVERY SYSTEM. DURING IMPLANT THE LEFT DISC OF THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 8MM AMPLATZER SEPTAL OCCLUDER. DURING IMPLANT, THE LEFT DISC OF THE DEVICE ALSO TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 9MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS IMPLANTED SUCCESSFULLY. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES, NOR WERE THERE ANY ANGULATIONS NOR KINKS NOTED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS IS NOTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277338 ↗
• InjuryAug 23, 2023Migration or Expulsion of Device; Patient-Device Incompatibility; Migration or Expulsion of Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE WAS PERFORMED. UNDER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), IT WAS DISCOVERED THAT THE PATIENT HAD TWO SMALL ASDS: ONE POSTERIOR, ONE ANTERIOR. THE POSTERIOR DEFECT WAS MEASURED TO BE 13MM, USING A 18MM AMPLATZER SIZING BALLOON II. THE ANTERIOR DEFECT WAS MEASURED TO BE 5.5MM, USING A 18MM AMPLATZER SIZING BALLOON II AND HAD A 1MM AORTIC RIM AT ITS MOST ANTERIOR POINT AND WAS OVAL-SHAPED, EXTENDING POSTEROSUPERIORLY ACROSS THE SEPTUM. A 14MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED ON THE POSTERIOR DEFECT, USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. A 07MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED ON THE ANTERIOR DEFECT, USING THE SAME 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. BOTH DEVICES PASSED THE PUSH/PULL TEST TO CONFIRM SUFFICIENT TISSUE CAPTURE AND STABILITY AND WERE RELEASED, RESPECTIVELY. ON (B)(6) 2023, IT WAS OBSERVED THAT THE 07MM AMPLATZER SEPTAL OCCLUDER HAD EMBOLIZED AND WAS FOUND IN THE DESCENDING AORTA. THE PATIENT EXPERIENCED MILD DISSECTION IN THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN SUSPECTS THE CAUSE OF EMBOLIZATION WAS DUE TO ANEURYSMAL SEPTUM. THE

  Patient problems: Vascular Dissection

  MAUDE report 17606088 ↗
• MalfunctionMay 16, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 7MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE OCCLUDER PRESENTS A COBRA DEFORMATION. THE PHYSICIANS REMOVED THE DEVICE FROM THE PATIENT, "MASSAGED" IT IN SOLUTION AND RELOAD IT ONE MORE TIME. THE SECOND ATTEMPT HAS THE SAME ISSUE. THE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE PHYSICIAN REPLACED THE DEVICE WITH A 9MM AMPLATZER SEPTAL OCCLUDER AMPLATZER THAT COMPLETED THE PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936756 ↗
• MalfunctionJan 25, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT A 7MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. THE DEVICE WAS USED FOR POST-INFARCT INTERVENTRICULAR DEFECT AND DEFORMED INTO COBRA SHAPE. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH ATRIAL STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. DEVICE WAS REPLACED WITH A 8MM AMPLATZER SEPTAL OCCLUDER. PATIENT STABLE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13351469 ↗
• MalfunctionAug 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2021, A 7MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT THE OCCLUDER DID NOT FORM WELL IN THE BODY AND A "COBRA" DEFORMATION WAS NOTED. THE OCCLUDER WAS REMOVED AND EXCHANGED FOR A NEW 7MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293061 ↗
• InjuryJun 18, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2019, A 7MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING PROCEDURE THE DEVICE EMBOLIZED FROM ATRIAL SEPTUM TO THE DESCENDING AORTA. THE DEVICE WAS SUCCESSFULLY REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Embolism

  MAUDE report 8708471 ↗