Amplatzer™ 9-VSD-MUSC-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00811806011820), received between Nov 24, 2019 and Mar 3, 2026 — classified as 5 injuries, 6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 12MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR A PROCEDURE USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE DO NOT TAKE PROPER 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 AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PROCEDURE GOT ABORTED. 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 24497866 ↗
• MalfunctionAug 29, 2025Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2025, A 12MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS CHOSEN FOR IMPLANTATION INTO A PSEUDOANEURYSM NECK PRESENT ON THE OUTSIDE WALL OF THE LEFT VENTRICLE. A GREATER THAN 80CM DELIVERY SHEATH WAS REQUIRED TO REACH THE DEFECT, SO A DELIVERY CABLE FROM AN AMPLATZER TREVISIO WAS USED WITH A NON-ABBOTT TERUMO SHEATH. THE SHEATH WAS ADVANCED TO THE DEFECT. ONCE THE ASO EXITED THE TIP OF THE SHEATH, IT DEFORMED INTO A COBRA SHAPE. THE ASO WAS REMOVED AND THE DEFORMATION WAS MASSAGED OUT. THE ASO WAS RE-LOADED WITH TENSION AND ATTEMPTED TO BE DEPLOYED AGAIN BUT DEFORMED INTO COBRA SHAPE ONCE MORE. IT WAS THOUGHT PAPILLARY STRANDS MAY HAVE PREVENTED A NORMAL DEPLOYMENT OR INTERACTION WITH THE NON-ABBOTT SHEATH. A 12MM AMPLATZER VENTRICULAR SEPTAL DEFECT OCCLUDER (VSD) WAS THEN CHOSEN FOR IMPLANTATION UTILIZING THE SAME NON-ABBOTT 7F DELIVERY SHEATH. THE VSD WAS HARD TO ADVANCE THROUGH THE SHEATH, SO THE SHEATH WAS EXCHANGED FOR A NON-ABBOTT 7F SHUTTLE SHEATH. THE 12MM VSD WAS DEPLOYED BUT WAS DEFORMED (ELONGATED AND BULBOUS) POSSIBLY DUE TO PAPILLARY MUSCLE AGAIN. 12MM VSD REMOVED AND EXCHANGED FOR 10MM VSD WITH THE SAME DELIVERY SYSTEM. THE 10MM VSD WAS DEPLOYED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22925998 ↗
• MalfunctionJun 19, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2024, A 12MM AMPLATZER VSD MUSCULAR OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F NON-ABBOTT SHEATH. DURING DEPLOYMENT, IT WAS 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 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 19569152 ↗
• MalfunctionFeb 6, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 12MM AMPLATZER VENTRICULAR SEPTAL DEFECT (VSD) MUSCULAR OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A NON-ABBOTT DELIVERY SYSTEM. DURING DEPLOYMENT THE DEVICE DEFORMED INTO A COBRA SHAPE, SO THE DEVICE WAS REMOVED. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE AND DID NOT INTERACT WITH CARDIAC STRUCTURES. THE PROCEDURE ENDED WITHOUT A REPLACEMENT DEVICE. THERE WAS NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652644 ↗
• InjuryNov 15, 2023Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18143001 ↗
• InjurySep 19, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN TO CLOSE THE POST-INFARCT VENTRICULAR SEPTAL DEFECT (PI-VSD) USING AN UNKNOWN DELIVERY SYSTEM. DURING PROCEDURE, THE PHYSICIAN WAS UNABLE TO CROSS THE DEFECT DUE TO ADVANCEMENT DIFFICULTY THROUGH PATIENT ANATOMY WITH THE DELIVERY SYSTEM. THE 16MM PLUG WAS NOT RELEASED FROM THE DELIVERY CABLE. A NEW 12MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN AND THE SIZING WAS DETERMINED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE 12MM OCCLUDER WAS IMPLANTED, AND FLUOROSCOPY SHOWED THAT THE DEVICE COMPLETELY DISLODGED FROM THE IMPLANT SITE AND HAD TRAVELLED TO THE RIGHT VENTRICLE. THERE WAS NO BLOCKAGE OF BLOOD FLOW. THE DEVICE WAS REMOVED USING A TRANSCATHETER SNARE. A NEW 18MM AMPLATZER VASCULAR PLUG II 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 TO BE RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773801 ↗
• MalfunctionFeb 27, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT WITH A 8F NON-ABBOTT DELIVERY SHEATH. DURING DEPLOYMENT, THE OPERATOR NOTED THAT THE DEVICE HAD A COBRA DEFORMATION. A DECISION WAS MADE TO RETRACT THE DEVICE AND ABORT THE PROCEDURE. IT WAS REPORTED THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT STATUS WAS REPORTED AS STABLE AND THERE WAS NO REPORT OF ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448857 ↗
• InjuryJul 29, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 10MM AMPLATZER VSD MUSCULAR OCCLUDER AND 12MM AMPLATZER VSD MUSCULAR OCCLUDER WERE SELECTED FROM AN IMPLANT ON (B)(6) 2022. THE DEFECT WAS SIZED USING ECHOCARDIOGRAM. DURING THE PROCEDURE, IT WAS REPORTED THAT 10MM AND 12MM AMPLATZER VSD OCCLUDER SHIFTED WITHIN THE INTENDED IMPLANT SITE TOWARDS THE LEFT VENTRICLE. IT IS UNKNOWN WHAT CAUSED THE DEVICES TO SHIFT IN POSITION. PATIENT WAS SENT TO EMERGENT OPEN HEART SURGERY TO RETRIEVE THE OCCLUDER. NO REPLACEMENT DEVICE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129318 ↗
• MalfunctionApr 27, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED A 12MM AMPLATZER VSD MUSCULAR WAS CHOSEN FOR IMPLANT PROCEDURE ON (B)(6) 2022. DURING PROCEDURE, UPON IN AN ATTEMPT TO DEPLOY THE DEVICE, THE DEVICE PRESENTED IN AN UNINTENDED SHAPE. THE DEVICE WAS REMOVED AND EXCHANGED FOR A NEW, 14MM AMPLATZER VSD MUSCULAR, THAT WAS SUCCESSFULLY IMPLANTED. 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 14216641 ↗
• InjuryFeb 17, 2021Migration

  ON (B)(6) 2021 A 12 MM AMPLATZER MUSCULAR VSD OCCLUDER WAS IMPLANTED. THE DEVICE LATER SHIFTED AND THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM ON (B)(6) 2021. THE DEVICE WAS SURGICALLY REMOVED AND THE DEFECT REPAIRED TO RESOLVE THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339021 ↗
• InjuryNov 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, A 12 MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR A POSTINFARCT VSD CLOSURE. THE DEVICE WAS DEPLOYED IN THE VSD, BUT DUE TO AN UNSTABLE POSITION IT WAS RECAPTURED/REDEPLOYED; IT WAS ALIGNED HORIZONTALLY AND NOT IN-LINE WITH THE SEPTUM. AFTER RECAPTURING THE DEVICE, THE DEFECT WAS LARGER THAN PRIOR TO THE PROCEDURE. THE PATIENT BECAME HYPOTENSIVE AND TACHYCARDIC, ECMO THERAPY WAS INITIATED, AND THE PATIENT WAS SENT TO CARDIAC SURGERY FOR VSD CLOSURE. THE DEFECT WAS SUCCESSFULLY CLOSED WITH A PATCH. THE PATIENT IS IN THE ICU AND REMAINS ON ECMO SUPPORT. THE USER INDICATED THAT THIS WAS A COMPLICATED SURGERY DUE TO THE UNSTABLE TISSUE (POST-ISCHEMIC, POST-INFARCT) OF THE DEFECT.

  Patient problems: Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 9367463 ↗