Amplatzer™ Septal Occluder (REF 9-ASD-024)Recalls & reported problems

Summary

The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 00811806010199), received between Jul 23, 2018 and Sep 25, 2026 — classified as 1 death, 56 injuries, 156 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (123 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 25 most recent of 213 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902999 ↗
• MalfunctionSep 18, 2026Difficult to Fold, Unfold or Collapse

  It was reported than 21 Aug 2026, an Amplatzer Septal Occluder was chosen for implant. During the procedure, it was noted that the device did not conform to its original configuration resulting in deformation. It was reported that Physician observed the third instance of device deformation out of the last four prostheses used over the past week. Furthermore, the physician reported that one of the discs was asymmetrical regarding the nitinol design, its diameter, and the positioning of the patch.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819133 ↗
• MalfunctionJul 27, 2026Difficult to Fold, Unfold or Collapse

  It was reported on (b)(6) 2026 that a 24mm Amplatzer Septal Occluder was chosen for implant using a 10F Amplatzer Trevisio delivery system. It was noted that the device was observed in a cobra shape despite multiple attempts to manipulate and recover it outside the body. The deformed device was never released from the delivery cable while inside the patient. There was no angulation or kink noted in the delivery system. There was no interaction with cardiac structures during deployment. The procedure was completed using a non-Abbott ASD device of same size. The patient remained hemodynamically stable throughout the procedure. There was no clinically significant delay in procedure and no adverse patient effects reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50025357 ↗
• MalfunctionJun 24, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 10F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING DEPLOYMENT IN THE LEFT ATRIUM, THE OCCLUDER WAS OBSERVED TO ASSUME A COBRA-LIKE DEFORMATION. THE PHYSICIAN SUBSEQUENTLY RETRIEVED THE DEVICE AND REMOVED IT FROM THE PATIENT, AFTER WHICH IT WAS MANUALLY RESHAPED IN AN ATTEMPT TO RESTORE ITS ORIGINAL CONFIGURATION. UPON REINTRODUCTION, THE DEVICE AGAIN EXHIBITED THE SAME COBRA-LIKE DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE DEVICE WAS NOT IMPLANTED, AND THE PROCEDURE WAS COMPLETED USING A NEW 26 MM AMPLATZER SEPTAL OCCLUDER WITH THE SAME DELIVERY SYSTEM. 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 25613690 ↗
• MalfunctionMar 31, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT (B)(6) 2026, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE DISPLAYED A CUP-SHAPED OPENING AND FAILED TO ASSUME ITS EXPECTED CONFIGURATION. THE OCCLUDER WAS SUBSEQUENTLY PLACED IN WARM SALINE IN AN EFFORT TO RESTORE THE NITINOL TO ITS ORIGINAL SHAPE, BUT THIS ATTEMPT WAS UNSUCCESSFUL. THE PHYSICIAN THEN PROCEEDED TO EVALUATE THE DEVICE IN SITU TO DETERMINE WHETHER IT WOULD CONFORM APPROPRIATELY; HOWEVER, THE ISSUE PERSISTED, CONFIRMING THE MATERIAL¿S NONCONFORMITY. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A NEW 24¿MM AMPLATZER SEPTAL OCCLUDER. 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 24749728 ↗
• MalfunctionMar 6, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER COULD NOT BE ADVANCED AS IT WAS OBSERVED TO BE BENT AND TOOK FORM OF COBRA DEFORMATION. IT WAS ALSO NOTED THAT ONLY THE FIRST ¿THREAD¿ WAS RELEASED; BOTH THREADS WERE NOT FULLY DEPLOYED. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 24MM AMPLATZER SEPTAL OCCLUDER. 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 24537136 ↗
• MalfunctionFeb 27, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE WAS NOT TAKING ITS PROPER SHAPE AND HAD A COBRA DEFORMATION. AFTER MULTIPLE ATTEMPTS, PHYSICIAN HAS TO TAKE THE DEVICE BACK. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE DEVICE WAS DISCARDED AS PATIENT WAS HIV +VE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469552 ↗
• MalfunctionFeb 20, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER DELIVERY SYSTEM. THE ATRIAL SEPTAL DEFECT MEASURED 19.0 × 22.6 MM, AND BALLOON SIZING YIELDED A STRETCHED DIAMETER OF 23¿24 MM; THEREFORE, A 24-MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. DURING THE PROCEDURE, WHILE DEPLOYING OF THE LEFT ATRIAL DISC IT WAS NOTED THAT THE OCCLUDER WAS CONFORMING TO COBRA- LIKE DEFORMATION, AND THEREFORE THE DEVICE WAS REPLACED FOR ANOTHER 24-MM AMPLATZER SEPTAL OCCLUDER. THE DEFORMED DEVICE WAS RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT, AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE REPLACEMENT DEVICE WAS DEPLOYED AND POSITIONED; HOWEVER, DURING THE WIGGLE TEST PERFORMED IMMEDIATELY PRIOR TO RELEASE, REPEATED DISENGAGEMENT FROM THE DEFECT WAS NOTED. DUE TO THE ASSOCIATED RISK OF EMBOLIZATION, THE DEVICE WAS NOT RELEASED AND WAS RETRIEVED. THE MIS-SIZING OF THE DEVICE WAS DETERMINED BY TEE (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) AND THERE ARE NO ALLEGATIONS TO THE SIZING OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING A 26

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405550 ↗
• MalfunctionJan 26, 2026Material Deformation

  IT WAS REPORTED ON (B)(6) 2025, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE OCCLUDER HAD A NITINOL MEMORY DEFECT WITH A TIGHT WAIST BETWEEN TWO DISCS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182904 ↗
• MalfunctionJan 12, 2026Difficult to Fold, Unfold or Collapse

  IT WAZS REPORTED THAT ON (B)(6) 2025, A 24MM AMPLATZER SEPTAL OCCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO DELIVERY SYSTEM FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE. DURING THE PROCEDURE, WHILE DEPLOYING THE LEFT DISC, IT WAS OBSERVED THAT OCCLUDER CONFORMED INTO A COBRA LIKE DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT, AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED BY USING A NEW 24MM AMPLATZER SEPTAL OCCCLUDER. 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 24035808 ↗
• MalfunctionDec 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889310 ↗
• MalfunctionNov 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23573387 ↗
• MalfunctionNov 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460689 ↗
• DeathOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. THE DEVICE WAS IMPLANTED. AFTER THE PROCEDURE, THE PATIENT PASSED AWAY DUE TO PERICARDIAL EFFUSION.

  Patient problems: Pericardial Effusion

  MAUDE report 23378755 ↗
• MalfunctionOct 6, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE LEFT DISC OF THE DEVICE DEFORMED INTO A COBRA SHAPE PRIOR TO RELEASE FROM DELIVERY CABLE. THE PROCEDURE WAS COMPLETED USING A NEW 26MM AMPLATZER SEPTAL OCCLUDER WITH 9F AMPLATZER TREVISIO DELIVERY SYSTEM. IT IS NOTED THAT THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE OBSERVED IN THE DELIVERY SYSTEM. IT IS REPORTED THAT THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23228413 ↗
• MalfunctionOct 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23210481 ↗
• MalfunctionAug 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 24MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A NON-ABBOTT DELIVERY SHEATH. DURING THE PROCEDURE THE LEFT DISC OF THE OCCLUDER TOOK ON A COBRA SHAPE. SEVERAL ATTEMPTS WERE MADE TO RE-DEPLOY THE OCCLUDER, HOWEVER THE COBRA SHAPE REMAINED. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A 24MM NON-ABBOTT DEVICE. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841038 ↗
• MalfunctionAug 18, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 24MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A NON-ABBOTT DELIVERY SHEATH. DURING THE PROCEDURE THE LEFT DISC OF THE OCCLUDER TOOK ON A COBRA SHAPE. SEVERAL ATTEMPTS WERE MADE TO RE-DEPLOY THE OCCLUDER, HOWEVER THE COBRA SHAPE REMAINED. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A 24MM NON-ABBOTT DEVICE. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828343 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 24MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2025, IT WAS NOTED THAT THE PATIENT DEVELOPED AN ONSET OF ATRIAL FIBRILLATION. THE DECISION WAS MADE TO ADMINISTERED THE PATIENT CORDARONE, BISOPROLOL AND APIXABAN. THE PATIENT WAS IN STABLE CONDITION AT THE TIME OF REPORT.

  Patient problems: Atrial Fibrillation

  MAUDE report 22772122 ↗
• MalfunctionAug 8, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750085 ↗
• MalfunctionAug 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689586 ↗
• MalfunctionAug 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689276 ↗
• MalfunctionJul 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592162 ↗
• MalfunctionJul 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522030 ↗
• MalfunctionMay 22, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION ON THE SECOND DEPLOYMENT. ON THE FIRST DEPLOYMENT, THE AORTIC END OF THE LEFT ATRIUM (LA) DISC LOOKED TO BE ON THE RIGHT ATRIAL (RA) SIDE. THE DEVICE WAS RECAPTURED AND RE-DEPLOYED AND THIS IS WHEN THE COBRA HEAD FORMED. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. A NEW 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071150 ↗