Amplatzer™ 9-VSD-MUSC-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00811806011844), received between Aug 6, 2019 and Jul 17, 2026 — classified as 2 deaths, 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (b)(6) 2026, A 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE DEVICE DID NOT TAKE DESIRED SHAPE RESULTING IN COBRA SHAPE AND IT WAS RETRIEVED BACK. THE PROCEDURE WAS ABORTED. 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 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 25861064 ↗
• DeathNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23649381 ↗
• MalfunctionApr 23, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F NON- ABBOTT DELIVERY SHEATH. DURING PROCEDURE, THE PHYSICIAN NOTED THAT THE DEVICE HAD A COBRA DEFORMATION. 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 DEVICE WAS RETRIEVED BACK. THE PROCEDURE WAS TERMINATED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164006 ↗
• MalfunctionOct 30, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FORM IMPLANT USING A 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, IT WAS NOTED THAT THE DEVICE WAS NOT TAKING THE DESIRED SHAPE AND THE DEVICE HAD A BULBOUS DEFORMATION. 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 PROCEDURE WAS ABANDONED. 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 DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030841 ↗
• MalfunctionOct 5, 2023Difficult to Fold, Unfold or Collapse; Off-Label Use; Difficult to Fold, Unfold or Collapse; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2023, A 18MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM (ITV). DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION. THERE WAS ANGULATION NOTED IN THE DELIVERY SYSTEM. THERE WAS NO KINK NOTICED ON THE DELIVERY SYSTEM. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A NEW 16MM AMPLATZER MUSCULAR VSD OCCLUDER AND 8F AMPLATZER TORQVUE DELIVERY SYSTEM (ITV) WAS SELECTED, IT HAD THE SAME DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A NEW 14MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED USING A AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT WAS NOT HEMODYNAMICALLY STABLE DURING THE PROCEDURE AS THEY WERE NOT STABLE PRIOR TO PROCEDURE. THE PATIENT WAS LATER REPORTED TO HAVE PASSED AWAY. THE PATIENT HAD MULTIPLE CO-MORBIDITIES, AND THE PHYSICIAN DID NOT ATTRIBUTE DEVICE PERFORMANCE TO THE PATIENT'S DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17880033 ↗
• MalfunctionSep 20, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023 A 16MM AMPLATZER VSD OCCLUDER (LOT: 7781019) WAS CHOSEN FOR IMPLANTATION UTILIZING AN UNKNOWN DELIVERY SYSTEM. A COBRA DEFORMATION OCCURRED. A REPLACEMENT 14MM AMPLATZER VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER (LOT: 7993734) WAS THEN ATTEMPTED TO BE USED BUT ALSO HAD A COBRA SHAPED DEFORMATION. THE PROCEDURE WAS ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AND NO ANGULATION OR KINK IN THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785038 ↗
• MalfunctionApr 3, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION OF THE RIGHT VENTRICULAR DISC. IT WAS REPORTED THERE WAS NO INTERACTION OF THE FREE WALL OF THE VENTRICLE. A DECISION WAS MADE TO REPLACE THE DEVICE WITH A SECOND 16MM AMPLATZER MUSCULAR VSD OCCLUDER. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCES AND THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667822 ↗
• DeathApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 16MM AMPLATZER VSD MUSCULAR OCCLUDER WAS SELECTED FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. APPROXIMATELY 45 MINUTES INTO THE PROCEDURE, THE DEVICE WAS DEPLOYED, AND PERICARDIAL EFFUSION WAS NOTICED ONCE THE DEVICE WAS IN PLACE. THE OCCLUDER HAD NOT YET BEEN RELEASED FROM THE DELIVERY SYSTEM. THE USER ATTEMPTED TO DRAIN THE EFFUSION. CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED BUT UNSUCCESSFUL. DURING CPR, THE DEVICE WAS RECAPTURED AND REMOVED ALONG WITH THE DELIVERY SYSTEM PRIOR TO RELEASE FROM THE DELIVERY CABLE. THE PERICARDIAL EFFUSION LEAD TO CARDIAC TAMPONADE, AND THE PATIENT PASSED AWAY. THE IMPLANTER WAS UNSURE OF WHAT CAUSED THE EFFUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 13996445 ↗
• MalfunctionFeb 2, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 16 MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, WHILE THE DEVICE WAS BEING DEPLOYED, IT PRESENTED IN A DEFORMED SHAPE. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13429513 ↗
• MalfunctionJan 31, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT A 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. THE DEVICE WAS NAVIGATED THROUGH NON ABBOTT DELIVERY SHEATH DURING DEPLOYMENT. HOWEVER THE PHYSICIAN DIDN'T ACHIEVED THE DESIRED SHAPE. IT SHAPE LIKE A COBRA HEAD. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH ATRIAL STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. NO DEVICE WAS IMPLANTED, PATIENT STABLE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13406277 ↗
• MalfunctionNov 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6), 2021. DEVICE APPEARED LIKE COBRA HEAD DURING DEPLOYMENT IN LEFT VENTRICLE. A NEW16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED BUT ALSO APPEARED LIKE COBRA HEAD PRIOR TO RELEASE FROM DELIVERY CABLE. DEVICE WAS REPLACED WITH A 14MM AMPLATZER MUSCULAR VSD OCCLUDER THAT WAS IMPLANTED. PATIENT STABLE. THERE IS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745090 ↗
• MalfunctionNov 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6), 2021. DEVICE APPEARED LIKE COBRA HEAD DURING DEPLOYMENT IN LEFT VENTRICLE. A NEW16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED BUT ALSO APPEARED LIKE COBRA HEAD PRIOR TO RELEASE FROM DELIVERY CABLE. DEVICE WAS REPLACED WITH A 14MM AMPLATZER MUSCULAR VSD OCCLUDER THAT WAS IMPLANTED. PATIENT STABLE. THERE IS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745053 ↗
• InjuryJun 2, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ON (B)(6) 2021, A 16MM AMPLATZER VSD OCCLUDER WAS IMPLANTED IN A PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), RV ENLARGEMENT, PULMONARY HYPERTENSION, AND CARDIOGENIC SHOCK. POST-IMPLANT, IT WAS REPORTED THAT RESIDUAL SHUNT WAS OBSERVED. ON (B)(6) 2021, THE PATIENT HEMOLYZED AND WAS TREATED WITH HEMODIALYSIS AND SUPPORTIVE CARE. NO MALFUNCTION WAS REPORTED WITH THE OCCLUDER. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS EVENT WILL BE CONSERVATIVELY REPORTED.

  Patient problems: Hemolysis

  MAUDE report 11924230 ↗
• InjuryAug 6, 2019Material Perforation; Material Perforation

  ON (B)(6) 2019, A 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT. THE PROCEDURE WAS COMPLEX AS THE PATIENT'S DEFECT WAS VERY APICAL. THERE WAS ALSO THE PRESENCE OF A PSEUDO-ANEURYSM LOCATED ON THE LATERAL WALL OF THE VD (VENTRICLE DEFECT) AND A LITANY OF TRABECULATIONS. AS THE PHYSICIAN WAS GETTING READY TO DEPLOY THE DEVICE AND A PERICARDIAL EFFUSION ON THE LATERAL SIDE OF THE VD WAS NOTED. THE PHYSICIAN QUICKLY DEPLOYED THE OCCLUDER AND PUNCTURED THE PERICARDIUM. 220CC OF BLOOD WAS EXTRACTED AND AFTER 125 MINUTES, A PERICARDIAL DRAIN WAS SET IN PLACE AND THE BLEEDING STOPPED. THE PROCEDURE TOOK LONGER THAN ANTICIPATED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. MANUFACTURER REPORT NUMBER: 2135147-2019-00224.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 8865385 ↗