Amplatzer™ Septal Occluder (REF 9-ASD-013)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00811806010106), received between Aug 10, 2018 and Oct 30, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 13MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING THE 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING THE DEVICE, THE LEFT ATRIAL DISC OF OCCLUDER FORMED A COBRA HEAD CONFIGURATION. THIS OCCURRED AS THE DEVICE WAS EXPANDING INSIDE THE BODY. THE DEFORMED OCCLUDER WAS RETRIEVED FROM THE PATIENT PRIOR TO ITS RELEASE FROM THE DELIVERY CABLE. NO CONTACT OCCURRED WITH INTRACARDIAC TISSUE DURING THE DEPLOYMENT AND NO BENDS OR KINKS WERE OBSERVED IN THE DELIVERY SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW 13 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 23431880 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED ON (B)(6) 2025 A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR), FLAILED LEAFLETS AND A DILATED LEFT ATRIUM FOR A MITRACLIP PROCEDURE. ONE MITRACLIP WAS IMPLANTED. A SECOND MITRACLIP (CDS0705-XTW, (B)(6)) ADVANCED. WHILE GRASPING, THE OPERATOR NOTED THAT THE ANTERIOR GRIPPER WAS NOT DROPPING DOWN. THE CLIP WAS INVERTED AND RETRACTED BACK TO LEFT ATRIUM. PER IMAGING, THE GRIPPER WAS STUCK ON THE CLIP ARM AND WAS UNABLE TO RAISE. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT FURTHER ISSUES NOTED. WHILE TESTING THE COMPLAINT DEVICE POST-PROCEDURE, THE GRIPPER WAS STUCK ON THE CLIP ARM AND UNABLE TO MOVE. THE CLIP HAD BEEN REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. TWO ADDITIONAL MITRACLIPS WERE IMPLANTED. THE FINAL MR GRADE WAS 2. THE PATIENT REMAINED HOSPITALIZED FOR 4 WEEKS. ON (B)(6) 2025 THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. IT WAS DISCOVERED THE MR GRADE INCREASED TO 4 AND AN 11.5MM ATRIAL SEPTAL DEFECT (ASD) DEVELOPED FROM THE TRANSSEPTAL PUNCTURE AND CROSSING OF THE MITRACLIP STEERABLE GUIDE CATHETER. TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND ANGIOGRAPHY WERE USED DURING THE PROCEDURE. A 12MM AMPLATZER VASCULAR PLUG

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320571 ↗
• MalfunctionMay 2, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 13MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F UNKNOWN DELIVERY SYSTEM. DURING PROCEDURE, THE OCCLUDER DEFORMED WITH A COBRA SHAPE. THE OCCLUDER WAS MASSAGED, BUT THE DEFORMATION PERSISTED. 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 WAS REMOVED. THE OCCLUDER WAS EXCHANGED FOR A NEW 13MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950980 ↗
• MalfunctionOct 7, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 13MM AMPLATZER SEPTAL OCCLUDER WAS SCELETED FOR AN IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (ATV). DURING THE PROCEDURE, WHEN THE LEFT DISK WAS DEVELOPED A COBRA WAS FORMED. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE AND REPLACE WITH A 20MM AMPLATZER SEPTAL OCCLUDER. NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM AND NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383114 ↗
• InjuryApr 16, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 13MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED INTO AN ATRIAL SEPTAL DEFECT (ASD) USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DIMENSION OF THE ASD WAS MEASURED TO BE 11-14MM, WHICH WAS DETERMINED VIA SIZING BALLOON OCCLUSION. ON (B)(6) 2023, IT WAS DISCOVERED ON A ROUTINE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THAT THE DEVICE HAD RELOCATED ANTERIORLY TO AN UNSTABLE POSITION IN THE HEART. THE DEVICE HAD SHIFTED SUCH THAT THE RIGHT ATRIAL DISC WAS PARTIALLY IN THE LEFT ATRIUM. SOME OF THE DISC WAS STILL HOLDING ONTO THE SEPTUM. THE PATIENT DID NOT COMPLAINT OF ANY SYMPTOMS. THE DEVICE WAS SURGICALLY EXPLANTED, AND A SURGICAL PATCH WAS APPLIED TO CLOSE THE ASD. THE PATIENT HAD PROLONGED HOSPITALIZATION TO RECOVER FROM SURGERY. THE CAUSE OF THE MIGRATION WAS BELIEVED TO BE DUE TO DEFICIENT POSTERIOR RIM. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748608 ↗
• MalfunctionNov 16, 2020Off-Label Use; Material Deformation; Off-Label Use; Material Deformation

  AN 12MM AMPLATZER SEPTAL OCCLUDER DEVICE WAS SELECTED FOR VSD IMPLANT. THE USER TRIED A 12MM AMPLATZER SEPTAL OCCLUDER(LOT NO: 6240039),AND IT FORMED A SHAPE OF A COBRA AND WOULDN'T SIT APPROPRIATELY. WE DECIDED WE WOULD TRY A 14MM AMPLATZER SEPTAL OCCLUDER(LOT NO: 7266691), THAT TOO ALSO FORMED A SHAPE OF A COBRA, BUT IN THIS CASE AFTER A COUPLE OF TRIES IT WOULDN'T GO BACK TO ORIGINALLY SHAPE AS GOOD AS IT SHOULD HAVE, THE SAME THING HAPPENED WITH 13MM AMPLATZER SEPTAL OCCLUDER (LOT NO: 6791191). IT WAS DECIDED TO TRY A MUSCULAR VSD, THEREFORE WE CLOSED THE SECOND HOLE WITH AN AVP2. THE PATIENT WASN'T HARMED AT DURING PROCEDURE. THE CASE JUST TOOK A LITTLE LONGER THAN HOPED. ADDITIONAL REPORTS FOR 9-ASD-014 (MDR-2020-48416), 9-ASD-012 (MDR-2020-48413).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10842830 ↗
• InjuryJan 2, 2019Material Deformation; Material Deformation

  ON (B)(6) 2018, TWO 13MM AMPLATZER SEPTAL OCCLUDERS (ASO) WERE SELECTED FOR USE. THE EVENT HAPPENED DURING THE PROCEDURE. WHEN A 13MM ASO WAS DELIVERED TO AND DEPLOYED IN THE LEFT ATRIAL, THE LEFT ATRIAL DISC OF ASO DEFORMED INTO A COBRA-HEAD SHAPE. THE 13MM ASO WAS ONCE PULLED BACK INTO THE DELIVERY SHEATH (MODEL AND LOT UNKNOWN) AND ANOTHER ATTEMPT TO DEPLOY WAS MADE BUT THE ISSUE PERSISTED. A SECOND 13MM AMPLATZER SEPTAL OCCLUDER WAS DEPLOYED, BUT ALSO HAD A DEFORMATION ISSUE. THE USER ELECTED TO ABORT THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. ANOTHER PERCUTANEOUS CLOSURE PROCEDURE WILL BE PLANNED IN 2019. PATIENT SPECIFIC INFORMATION OF PATIENT IDENTIFIER, AGE OR BIRTHDATE, GENDER, AND WEIGHT ARE NOT AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8208752 ↗
• InjuryAug 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, AN 8 FR AMPLATZER TORQVUE 45 DELIVERY SYSTEM (LOT. 6298737) WAS USED TO IMPLANT A 13 MM AMPLATZER ATRIAL SEPTAL OCCLUDER IN A PEDIATRIC PATIENT. THE PROCEDURE WAS WITHOUT EVENT. ON (B)(6) 2018, THE PATIENT FELL AND TOOK A HIT TO THE CHEST. FOLLOWING THAT THE PATIENT STARTED TO FEEL CHEST PAIN AND WAS REFERRED TO A LOCAL HOSPITAL WHERE THE IMPLANT HAD NOT OCCURRED. A PERICARDIAL EFFUSION WAS SEEN AT TTE AND THE PATIENT UNDERWENT CARDIAC SURGERY ON (B)(6) 2018. A PERFORATION OF THE ROOF OF THE LEFT ATRIUM WAS FOUND. THE DEVICE WAS REMOVED AND THE DEFECT WAS CLOSED WITH A BOVINE PERICARDIAL PATCH. THE PATIENT WAS REPORTED IN GOOD CONDITION AND STABLE. PER REPORT FROM THE USER THE CAUSE OF THIS EVENT IS UNKNOWN.

  Patient problems: Cardiac Perforation; Chest Pain; Pericardial Effusion

  MAUDE report 7772151 ↗