Amplatzer™ Septal Occluder (REF 9-ASD-006)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00811806010038), received between Jun 10, 2019 and Aug 21, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50378639 ↗
• MalfunctionDec 30, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924508 ↗
• MalfunctionSep 12, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042945 ↗
• MalfunctionSep 9, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A PROCEDURE USING AN UNKNOWN DELIVERY SYSTEM. DURING PROCEDURE, THE OCCLUDER TOOK THE FORM OF COBRA DEFORMATION. AFTER MULTIPLE ATTEMPTS, STILL FAILED. A NEW 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008189 ↗
• MalfunctionAug 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT IN A PATIENT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE OCCLUDER WAS BEING USED TO TREATED A ATRIAL SEPTAL DEFECT. IT WAS NOTED DURING PROCEDURE THAT THE OCCLUDER A DEFORMATION WHEN DEPLOYED. ECHOCARDIOGRAPHY WAS USED TO CONFIRM THE DEFORMATION OF THE 8MM AMPLATZER SEPTAL OCCLUDER WHILE IT WAS INSIDE THE PATIENT. THERE WAS CONTACT WITH INTRACARDIAC STRUCTURES DURING THE DEPLOYMENT. THE TYPE OF DEFORMATION OBSERVED WAS ELONGATION. THE DECISION WAS MADE TO RECAPTURED THE OCCLUDER. THE DEFORMED OCCLUDER WAS RETRIEVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE INSIDE THE PATIENT. THERE WERE NO BENDS OR KINKS OBSERVED IN THE DELIVERY SYSTEM. A REPLACEMENT 18MM AMPLATZER CRIBRIFORM OCCLUDER WAS PREPARED AND SUCCESSFULLY IMPLANTED USING THE SAME DELIVERY SYSTEM. THE PATIENT EXPERIENCED NO CLINICAL SIGNS OR SYMPTOMS DURING OR AFTER THE EVENT, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690520 ↗
• InjuryApr 10, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON 18 MARCH 2025 A 6MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT TO TREAT AN IATROGENIC ATRIAL SEPTAL DEFECT (IASD). THE PATIENT HAD AN ANOMALOUS LEFT UPPER PULMONARY VEIN THAT DRAINED INTO THE RIGHT ATRIUM AND A LARGE LEFT ATRIAL APPENDAGE (LAA). NUMEROUS ATTEMPTS WERE MADE TO PASS A STIFF WIRE INTO THE LEFT UPPER VEIN BUT WERE UNSUCCESSFUL. THE WIRE CONTINUED TO GO INTO THE RIGHT LOWER PULMONARY VEIN, HOWEVER THE PATIENT EXPERIENCED A BRIEF DROP IN BLOOD PRESSURE AND A SHORT DURATION OF BRADYCARDIA WHEN THE WIRE WAS LEFT IN FOR TOO LONG. A 3-DIMENSIONAL IMAGE OF THE DEFECT WAS CAPTURED, MEASURING THE DEFECT AT 4.5-5MM. DURING THE PROCEDURE THE OCCLUDER WAS PARTIALLY RE-CAPTURED ONCE. TRANSTHORACIC ECHOCARDIOGRAM (TTE) CONFIRMED GOOD DEVICE PLACEMENT WITH RIM CAPTURE AND A PUSH AND PULL TEST WAS SUCCESSFULLY PERFORMED. UPON RELEASE FROM THE DELIVERY CABLE, THE OCCLUDER EMBOLIZED TO THE LEFT VENTRICLE. AN ATTEMPT WAS MADE TO SNARE THE DEVICE WITH A GOOSE NECK SNARE, HOWEVER THE OCCLUDER WAS PUSHED INTO THE DESCENDING AORTA. THE PHYSICIAN WENT RETROGRADE THROUGH THE LEFT FEMORAL ARTERY TO SNARE THE OCCLUDER. THERE WAS DIFFICULTY SNARING THE PIN ON THE OCCLUD

  Patient problems: Anemia; Low Blood Pressure/ Hypotension

  MAUDE report 21816395 ↗
• MalfunctionDec 16, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD). AN 18MM SIZING BALLOON WAS USED TO SELECT THE DEVICE SIZE. DURING DEPLOYMENT OF THE DEVICE, IT FORMED A COBRA HEAD DEFORMATION AND COULD NOT BE REPOSITIONED. CONTACT WITH INTRACARDIAC TISSUE OCCURRED DURING THE OCCLUDER DEPLOYMENT. THE DEVICE WAS REMOVED FROM THE BODY TO SEE IF THE DEFORMATION WOULD REVERT, BUT IT DID NOT. THERE WERE NO BENDS OR KINKS BEEN OBSERVED IN THE DELIVERY SHEATH. A NEW 6MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED USING THE SAME DELIVERY SYSTEM WITHOUT ANY ISSUES. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20943086 ↗
• MalfunctionSep 3, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, AFTER THE LAA WAS CLOSED VIA ATRIAL SEPTAL PUNCTURED APPROACH, THERE WAS RIGHT TO LEFT SHUNT FLOW OCCURRING WHICH STARTED TO DECLINE THE BLOOD OXYGEN SATURATION (SPO2). AN IATROGENIC ATRIAL SEPTAL DEFECT (IASD) WAS DIAGNOSED. A 6MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS ATTEMPTED FOR CLOSURE OF THE IASD. HOWEVER, THE OCCLUDER DEFORMED INTO THE COBRA-HEAD SHAPED. THE DEVICE WASN'T RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES OR ANGULATION/KINK IN THE DELIVERY SYSTEM. THE DEVICE WAS REPLACED WITH A 7MM ASO TO RESOLVE THE EVENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE AND SPO2 RETURNED TO NORMAL LEVEL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130924 ↗
• MalfunctionSep 15, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 6MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER FORMED COBRA PHENOMENON AND WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. DEVICE WAS REPLACED WITH A 8MM AMPLATZER SEPTAL OCCLUDER THAT WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756576 ↗
• MalfunctionSep 13, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 6MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM(ITV). DURING PROCEDURE, THE OCCLUDER FORMED COBRA PHENOMENON. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FORM THE DELIVERY CABLE. NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. A NEW 6MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739137 ↗
• MalfunctionFeb 1, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 6MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE DEFORMED INTO A COBRA AND IT TOOK "APPROXIMATELY 8 ATTEMPTS BY THE CARDIOLOGIST TO FIX THIS DEVICE IN THE DEFECT AREA." HOWEVER, THE DEFORMATION PERSISTED. THE DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM AND NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. A 7 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED AS A REPLACEMENT THAT COMPLETED THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277740 ↗
• MalfunctionMar 30, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 6MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT ON (B)(6) 2022. DURING THE PROCEDURE, IN AN ATTEMPT TO DEPLOY THE DEVICE, THE OCCLUDER PRESENT WITH A COBRA SHAPE DEFORMATION. STILL CONNECTED TO THE CABLE, THE DEVICE WAS REMOVED. A NEW 6MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. IT WAS NOTED THAT THERE WAS A 15 DELAY IN THE PROCEDURE THAT WAS NOT CLINICALLY SIGNIFICANT. THE PATIENT REMAINED STABLE, NO ADVERSE EVENTS REPORTED. THE PATIENT WAS DISCHARGED THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13946145 ↗
• MalfunctionNov 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED ON 27 OCTOBER 2021, A 6MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT A COBRA DEFORMATION WAS NOTED. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW 18MM AMPLATZER PFO OCCLUDER. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750640 ↗
• MalfunctionJul 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 6 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, WHILE DEPLOYING THE DEVICE, THE DISTAL DESK PRESENTED IN A COBRA DEFORMATION. ATTEMPTS TO RETURN THE DEVICE TO IT'S NORMAL SHAPED WERE UNSUCCESSFUL. THE DEVICE WAS REPLACED WITH A NEW 6 MM AMPLATZER SEPTAL OCCLUDER AND SUCCESSFULLY IMPLANTED TO RESOLVE THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS CURRENTLY STABLE WITH NO ADVERSE EVENTS.. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253358 ↗
• InjuryApr 27, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2021, A 6MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED WITH NO REPORTED COMPLICATIONS. ON (B)(6) 2021, THE PATIENT DEVELOPED LEG PAIN. TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED, WHICH SHOWED THAT THE DEVICE EMBOLIZED INTO THE POPLITEAL ARTERY. PERCUTANEOUS RETRIEVAL OF THE DEVICE WAS ATTEMPTED, HOWEVER UNSUCCESSFUL. ON (B)(6) 2021, SURGICAL REMOVAL WAS PERFORMED. THE USER ALLEGED THAT THE CAUSE OF THE OCCLUDER EMBOLIZING WAS DUE TO AN UNDERSIZED DEVICE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Pain

  MAUDE report 11732216 ↗
• MalfunctionApr 20, 2021Material Deformation; Material Deformation

  ON (B)(6) 2021, A 6MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING PROCEDURE, A COBRA DEFORMATION WAS OBSERVED WHILE DEPLOYING AND THE DEVICE WAS NOT IMPLANTED. A NEW COMPETITOR'S DEVICE WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693173 ↗
• InjuryNov 20, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020, A 6MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED IN THE PATIENT'S DEFECT. ON (B)(6) 2020, THERE WAS NO SYMPTOM ON THE PATIENT, BUT A ROUTINE ULTRASOUND CARDIOGRAPHY WAS OBTAINED. THEN THE ASO WAS FOUND TO HAVE BECOME DISLODGED FROM THE DEFECT. BY ABDOMINAL CT, THE ASO WAS LOCATED NEAR THE COMMON ILIAC ARTERY. BY USING A 9FR SHEATH AND A DOUBLE SNARE TECHNIQUE, THE ASO WAS REMOVED FROM THE PATIENT PERCUTANEOUSLY WITHOUT MUCH BLEEDING OF THE PATIENT. THE PATIENT'S GENERAL CONDITION IS STABLE, AND THE PATIENT WILL BE CLOSELY MONITORED. THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10879570 ↗
• InjuryJun 10, 2019Material Deformation; Material Deformation

  ON (B)(6) 2019, A 6MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. THE DEVICE WAS DEPLOYED BUT DEPLOYED DEFORMED. THE DEVICE WAS RETRACTED, RINSED, MANIPULATED TO CORRECT THE SHAPE, REDEPLOYED, BUT THE ISSUE REMAINED. THE DEVICE WAS EXCHANGED WITH A LIKE DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8685622 ↗