Amplatzer™ Septal Occluder (REF 9-ASD-010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 00811806010076), received between Aug 27, 2018 and Sep 18, 2026 — classified as 37 injuries, 257 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (194 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 294 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819541 ↗
• MalfunctionAug 14, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261225 ↗
• MalfunctionAug 14, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261189 ↗
• MalfunctionAug 7, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2026, a 10mm Amplatzer Septal Occluder was chosen for implant using a 7F Amplatzer Torqvue Delivery System. During the procedure, it was noted that the occluder was conformed to cobra shape. 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 device remained outside the patient while efforts were made to manually restore the occluder to its intended configuration. The occluder successfully returned to its normal shape following manual manipulation. After confirming the device configuration was satisfactory, the device was implanted. 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 50181939 ↗
• MalfunctionJul 10, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785597 ↗
• MalfunctionApr 23, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT (B)(6) 2026, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING 7F AMPLATZER TREVISO DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE OCCLUDER CONFORMED INTO COBRA DEFORMATION S WHEN THE DEVICE WAS EXPANDING INSIDE THE BODY. 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 USING A NEW 10MM 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 24961527 ↗
• MalfunctionApr 17, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER SEPTAL OCCLUDER (ASD) WAS CHOSEN FOR A PROCEDURE USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE PREPARED ACCORDING TO INSTRUCTIONS FOR USE (IFU). WHEN THEY OPENED THE LEFT DISC, IT FORMED AS A COBRA. THEY TOOK OUT THE ASD AGAIN AND RESHAPED IT. AFTER SOME STRUGGLING, THEY MANAGED TO GET BACK A NORMAL SHAPE AND TRIED TO IMPLANT IT AGAIN BUT IT SHAPED AS A COBRA AGAIN. THE DEVICE WAS EXCHANGED WITH A NEW 10MM AMPLATZER SEPTAL OCCLUDER AND IT WAS IMPLANTED WITHOUT ANY PROBLEM. THERE WAS NO PROBLEM FOR THE PATIENT. 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. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911711 ↗
• MalfunctionApr 1, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE OCCLUDER DID NOT CONFORM TO ITS DESIRED SHAPE AND TOOK FORM OF A COBRA 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 ABORTED. 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 24758462 ↗
• MalfunctionMar 30, 2026Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE OCCLUDER DID CONFORM INTO ITS DESIRED SHAPE BUT IT WAS IMPLANTED. 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 DEVICE MADE CONTACT WITH THE PATIENT. 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 24737808 ↗
• MalfunctionMar 13, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 5F NON-ABBOTT SHEATH. DURING PROCEDURE, THE DEVICE HAD A COBRA SHAPE. SEVERAL ATTEMPTS WERE MADE, BUT THE LEFT DISC DID NOT CONFORM PROPERLY. A NEW 11MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589994 ↗
• MalfunctionMar 13, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO DELIVERY SYSTEM. THE FLUSHING WAS DONE ACCORDING TO IFU. DURING DEPLOYMENT, THE LEFT ATRIAL DISC WAS OBSERVED TO TAKE ON A COBRA-TYPE CONFIGURATION, AND THE DEVICE WAS SUBSEQUENTLY REMOVED WITHOUT BEING RELEASED FROM THE DELIVERY CABLE. 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 THEN CONTINUED WITH THE SELECTION AND PLACEMENT OF AN 11 MM AMPLATZER SEPTAL OCCLUDER. DURING TRANSESOPHAGEAL ECHOCARDIOGRAPHIC ASSESSMENT, THE DEVICE APPEARED OVERSIZED. WHEN AN ATTEMPT WAS MADE TO RECAPTURE THE DEVICE, IT COULD NOT BE FULLY WITHDRAWN INTO THE 7 F AMPLATZER TREVISIO DELIVERY SYSTEM. THE DECISION WAS MADE TO RELEASE THE DEVICE AND MONITOR THE PATIENT CLOSELY. 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 24589515 ↗
• MalfunctionMar 13, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING THE LEFT DISC, IT WAS NOTED THAT THE OCCLUDER CONFORMED INTO COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A 11 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 24589322 ↗
• MalfunctionMar 12, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT OCCLUDER CONFORMED INTO A COBRA-LIKE DEFORMATION WHEN DEPLOYED INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND ATTEMPTED MULTIPLE TIMES IN STERILE SALINE SOLUTION BUT THE OCCLUDER WAS STILL CONFORMING TO COBRA-LIKE DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. IT WAS NOTED THAT THE DEVICE WAS OPENED IN LEFT ATRIA AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 10MM 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 24584312 ↗
• MalfunctionMar 6, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537221 ↗
• MalfunctionMar 3, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTATION, IT WAS NOTED THAT OCCLUDER WAS CONFIRMING TO A COBRA LIKE DEFORMATION AND NOT TAKING ITS DESIRED SHAPE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 10MM 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 24503026 ↗
• MalfunctionMar 3, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE ATTEMPTED THROUGH THE DELIVERY SHEATH AND WHEN THEY EXPOSED THE LEFT ATRIAL DISC, THE DISC MALFORMED INTO A COBRA HEAD SHAPE IMMEDIATELY AFTER PUSHING THE DISC OUT. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE FROM THE PATIENT BODY AND PROCEED WITH A NEW 10MM AMPLATZER SEPTAL OCCLUDER. THE LEFT ATRIAL DISC ALSO HAD A DEFORMED DISC INTO THE SHAPE OF COBRA HEAD, BUT THEY WERE ABLE TO REFORM IT APPROPRIATELY AND IMPLANTED THE 2ND DEVICE INTO THE ATRIAL DEFECT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501542 ↗
• MalfunctionFeb 13, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 MIXED MITRAL REGURGITATION (MR) AND AN ENLARGED ATRIUM FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A STEERABLE GUIDE CATHETER (SGC) WOULD NOT CLICK INTO THE STABILIZER SMOOTHLY. IT WAS NOTED THAT THE PHYSICIAN REQUIRED INCREASED FORCE TO INSERT SGC INTO THE STABILIZER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER THE PROCEDURE, IT WAS DIFFICULT TO REMOVE THE SGC FROM THE STABILIZER. TROUBLESHOOTING WAS PREFORMED AND IT REQUIRED SIGNIFICANT FORCE TO REMOVE THE SGC FROM THE STABILIZER. THE FINAL MR WAS GRADE 2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. DUE TO A RIGHT TO LEFT SHUNT, IT WAS DECIDED TO CLOSE THE IATAROGENIC ATRIAL SEPTAL DEFECT WITH A 10MM AMPLATZER SEPTAL OCCLUDER AND 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING IMPLANT, THE OCCLUDER DEFORMED INTO A COBRA SHAPE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 10MM AMPLATZER SEPTAL OCCLUDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338868 ↗
• MalfunctionFeb 13, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 MIXED MITRAL REGURGITATION (MR) AND AN ENLARGED ATRIUM FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A STEERABLE GUIDE CATHETER (SGC) WOULD NOT CLICK INTO THE STABILIZER SMOOTHLY. IT WAS NOTED THAT THE PHYSICIAN REQUIRED INCREASED FORCE TO INSERT SGC INTO THE STABILIZER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER THE PROCEDURE, IT WAS DIFFICULT TO REMOVE THE SGC FROM THE STABILIZER. TROUBLESHOOTING WAS PREFORMED AND IT REQUIRED SIGNIFICANT FORCE TO REMOVE THE SGC FROM THE STABILIZER. THE FINAL MR WAS GRADE 2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. DUE TO A RIGHT TO LEFT SHUNT, IT WAS DECIDED TO CLOSE THE IATAROGENIC ATRIAL SEPTAL DEFECT WITH A 10MM AMPLATZER SEPTAL OCCLUDER AND 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING IMPLANT, THE OCCLUDER DEFORMED INTO A COBRA SHAPE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 10MM AMPLATZER SEPTAL OCCLUDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338867 ↗
• MalfunctionJan 30, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTING, IT WAS NOTED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE AND TOOK FORM OF A COBRA DEFORMATION DURING THE DEVICE DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING A 09 MM AMPLATZER SEPTAL OCCLUDER. 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 24223995 ↗
• MalfunctionJan 23, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161331 ↗
• MalfunctionJan 16, 2026Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099107 ↗
• MalfunctionJan 2, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 10 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER CONFORMED INTO A COBRA DEFORMATION. THE PROCEDURE WAS REPLACED BY AN 9MM AMPLATZER SEPTAL OCCLUDER. 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 23950740 ↗
• MalfunctionJan 2, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER CONFORMED INTO A COBRA LIKE DEFORMATION. THE PROCEDURE WAS COMPLETED USING A 24MM AMPLATZER SEPTAL OCCLUDER. 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 23950606 ↗
• MalfunctionJan 2, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE CONFORMED INTO A COBRA LIKE DEFORMATION. THE PROCEDURE WAS COMPLETED USING A NEW 10MM AMPLATZER SEPTAL OCCLUDER. 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 23950594 ↗
• MalfunctionDec 23, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO DEPLOY THE LOADER, THE OCCLUDER CONFORMED INTO A COBRA DEFORMATION. THE PROCEDURE WAS COMPLETED USING A COMPLETED USING A NEW ONE. 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 23881320 ↗