Amplatzer™ Septal Occluder (REF 9-ASD-036)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00811806010250), received between Aug 28, 2020 and Apr 7, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 36MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYMENT, IT WAS NOTED THAT THE OCCLUDER DID NOT CONFORM INTO ITS DESIRED SHAPE AND TOOK FORM OF COBRA DEFORMATION, THEREFORE IT WAS RETRIEVED BACK. THE PROCEDURE WAS ABORTED. 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 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 24810361 ↗
• MalfunctionJan 30, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 36MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12 F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER CONFORMED INTO A COBRA-LIKE DEFORMATION. THE PROCEDURE WAS COMPLETED USING A 36MM NON-ABBOTT DEVICE. 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 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 24226247 ↗
• 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 22591932 ↗
• MalfunctionNov 27, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING AN UNKNOWN NON-ABBOTT DELIVERY SYSTEM TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). THE ASD WAS MEASURED AT 28MM. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 36MM AMPLATZER SEPTAL OCCLUDER. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT. 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 20790082 ↗
• MalfunctionAug 30, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 36MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, WHEN THE DEVICE WAS DEPLOYED, IMPROPER SHAPE WAS OBSERVED AS THE DEVICE AS DEFORMED INTO A COBRA SHAPE. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO CORRECT THE SHAPE, BUT THE DEFORMATION PERSISTED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE DEVICE WAS RE-SHEATHED AND REMOVED; IT WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A REPLACEMENT DEVICE WAS NOT IMPLANTED AND THE CASE WAS ABANDONED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20107165 ↗
• MalfunctionJun 25, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 36MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, WHILE THE DEVICE WAS BEING DEPLOYED, THE FIRST DISC WAS PLACED IN THE DEFECT. HOWEVER, IT HAD TO BE RECAPTURED TWICE BECAUSE THE DEVICE DIDN'T FIT PROPERLY WITH RESPECT TO THE AORTIC DORSUM. WHEN THE OCCLUDER WAS DEPLOYED ON THE THIRD ATTEMPT, IT PRESENTED IN A COBRA DEFORMATION. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES OR KINK/ANGULATION NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AND IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607435 ↗
• InjuryApr 9, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 36MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 13F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEVICE WAS IMPLANTED. THE PATIENT HAD A PRE-EXISTING CONDITION OF ATRIAL FIBRILLATION. FLUOROSCOPY AND ECHOCARDIOGRAM (ECHO) WAS USED DURING THE PROCEDURE. THE ATRIAL SEPTAL DEFECT WAS MEASURED AS 28MM IN ECHO, 31.7MM ON ECHO WITH A BALLOON AT STOP FLOW, AND 37MM ON ANGIOGRAPHY. SIZING WAS TAKEN FROM THE BALLOON MEASUREMENT. THE DEVICE WAS IMPLANTED. THE DECISION WAS MADE TO PERFORM CARDIOVERSION. THE CARDIOVERSION CAUSED THE DEVICE TO EMBOLIZE TO THE LEFT ATRIUM. THE DEVICE WAS SNARED WITH A TRANSCATHETER SNARE AND REMOVED FROM THE PATIENT. A NEW 40MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. THE DEVICE WAS IMPLANTED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072987 ↗
• MalfunctionJan 29, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 04 JANUARY 2024, A 36MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION AFTER FULL DEPLOYMENT. THE LEFT DISC OPENED WELL, BUT THE RIGHT DISC COULD NOT OPEN AND FORMED A COBRA SHAPE. 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. WHEN THE IMPLANTER TRIED TO PULL IN THE DEVICE AND RETRIEVE THE SHEATH, THE LEFT DISC WAS NOT ABLE RE-SHEATH. THE IMPLANTER USED GREAT FORCE TO PULL DEVICE INTO SHEATH, WITH THE DISTAL PART STILL PARTIALLY EXPOSED OUTSIDE THE SHEATH WHILE REMOVING THE WHOLE SYSTEM. THIS CAUSED A TEAR IN THE FEMORAL VEIN, BUT NO MAJOR BLEEDING OCCURRED. UPON INSPECTION, THE DELIVERY SYSTEM HAD CRUMBLED DUE TO THE FORCE USED TO RETRACT THE DEVICE. A NEW 34MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596795 ↗
• MalfunctionJan 8, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 36MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2023. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 36MM AMPLATZER SEPTAL OCCLUDER. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED AND REPLACED WITH A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE AFFECTS TO THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED IN 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 18468106 ↗
• MalfunctionJan 8, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 36MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2023. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 36MM AMPLATZER SEPTAL OCCLUDER. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED AND REPLACED WITH A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE AFFECTS TO THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED IN 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 18468098 ↗
• MalfunctionMay 1, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 06 APRIL 2023, A 36 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION INTO AN ATRIAL SEPTAL DEFECT (ASD) UTILIZING AN 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE ASD WAS MEASURED TO BE SLIGHTLY GREATER THAN 32 MM. DURING DEPLOYMENT, THE LEFT DISC OF THE DEVICE INVERTED AND BECAME CONICAL WHILE ATTEMPTING TO RECAPTURE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. IT TOOK A FEW ATTEMPTS TO GET THE OCCLUDER BACK INTO THE DELIVERY SYSTEM. THE DEVICE WAS DEPLOYED AND RECAPTURED MULTIPLE TIMES DURING THE PROCEDURE BUT STILL EXHIBITED THE SAME DEFORMATION. THE DEVICE WAS REMOVED FROM THE PATIENT, DEPLOYED OUTSIDE OF THE PATIENT ON THE BACK TABLE, AND THEN RE-INSERTED INTO THE PATIENT, BUT THE SAME DEFORMATION WAS STILL OBSERVED. THE DEVICE WAS REPLACED WITH A 38 MM AMPLATZER SEPTAL OCCLUDER, BUT THE DEVICE WAS DETERMINED TO BE TOO LARGE FOR THE DEFECT. THERE WAS NO ANGULATION OR KINK IN THE DELIVERY SYSTEM. NO DEVICE WAS IMPLANTED. THERE WAS A SIGNIFICANT DELAY IN PROCEDURE, BUT THE PATIENT WAS NOT HEMODYNAMICALLY COMPROMISED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845000 ↗
• MalfunctionSep 29, 2020Material Deformation; Material Deformation

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). ON (B)(6) 2020, I DECIDED TO IMPLANT A 24MM AMPALTZER SEPTAL OCCLUDER. THE DEVICE ENDED UP BEING TOO SMALL FOR THE DEFECT, AND THE PHYSICIAN DECIDED TO USE A 36MM. WHEN THE PHYSICIAN UNSHEATHED THE LEFT DISC THE DEVICE FORMED A COBRA SHAPE. THE PHYSICIAN THEN RE-SHEATHED THE DEVICE, AND REMOVED IT FROM THE PATIENT'S BODY. THE PHYSICIAN DECIDED TO USE THE 38MM AND UNSHEATHED THE RIGHT DISC DURING THE PROCEDURE, AND THE DISC FORM COBRA SHAPE. THE PHYSICIAN THEN REMOVED THE DEVICE FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS ABORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10601173 ↗
• InjuryAug 28, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020 A 34MM ASD DEVICE WAS PREPPED AND DELIVERED TO THE DEFECT. THE PATIENT HAS A BASELINE RHYTHM OF SINUS RHYTHM. SIGNIFICANT RESIDUAL SHUNTING WAS NOTED ON AN ECHO AND THE 34MM DEVICE WAS NOT RELEASED DUE TO RESIDUAL SHUNTING BY ECHO. A 36MM ASD DEVICE WAS PREPPED AND DELIVERED TO THE DEFECT. THE ECHO SHOWED NO RESIDUAL SHUNT AND WAS STABLE. THE DEVICE WAS RELEASED AND APPEARED TO REMAIN IN A STABLE POSITION ON TEE. APPROXIMATELY 3 MINUTES LATER THE PATIENT EXPERIENCED VENTRICULAR ECTOPY AND TEE CONFIRMED THAT THE DEVICE HAD EMBOLIZED INTO THE RIGHT ATRIUM. THE PATIENT RETURNED TO SINUS RHYTHM SOON AFTER. THE 36MM DEVICE WAS RETRIEVED IN THE OR AND THE DEFECT WAS CLOSED SURGICALLY WITH A PATCH. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED STABLE THROUGH OUT THE ENTIRE PROCEDURE.

  Patient problems: Embolism; No Consequences Or Impact To Patient; Ventricle, Abnormality Of

  MAUDE report 10469208 ↗