Amplatzer™ 9-VSD-MUSC-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00811806011813), received between Mar 1, 2020 and Feb 27, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR A VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE PROCEDURE USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT WAS A 67-YEAR-OLD FEMALE WITH A HIGH MUSCULAR VSD THAT APPEARED POST-MYOCARDIAL INFARCTION IN 2024. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED BASELINE TRICUSPID REGURGITATION, RIGHT VENTRICULAR DYSFUNCTION, AND A CAVERNOUS DEFECT MEASURING 18 MM INTERNALLY, WITH 7MM OFFSET OPENINGS ON THE RIGHT AND LEFT SIDES WITH A SEPTAL WIDTH OF 8MM. THE LEFT SIDE OF THE DEFECT SHOWED SUFFICIENT RIMS; HOWEVER, THE RIGHT SIDED OPENING WAS MILDLY HIGHER AND NEARER TO THE TRICUSPID VALVE LEAFLET. AFTER PLACEMENT OF A GUIDE WIRE, THE PHYSICIAN DETERMINED THEY WANTED TO SWITCH OUT THE WIRE AND GO BARE ACROSS THE SEPTUM WITH A NEW NON-ABBOTT WIRE. AFTER PLACEMENT OF THE NEW WIRE THE PHYSICIAN WAS HAVING DIFFICULTY CROSSING THE DEFECT WITH THE SHEATH AND DILATOR. THERE WAS A RESISTANCE FELT AND THEN DECIDED TO ATTEMPT AN ANTEGRADE APPROACH. THE PHYSICIAN THEN WENT TO AN ANTEGRADE APPROACH, AT THIS POINT THE WIRE HAD STILL BEEN BARE ACROSS THE VSD AT THE MD'S REQUEST. THE DELIVERY SYSTEM CROSSED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469723 ↗
• MalfunctionFeb 27, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR A VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE PROCEDURE USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT WAS A 67-YEAR-OLD FEMALE WITH A HIGH MUSCULAR VSD THAT APPEARED POST-MYOCARDIAL INFARCTION IN 2024. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED BASELINE TRICUSPID REGURGITATION, RIGHT VENTRICULAR DYSFUNCTION, AND A CAVERNOUS DEFECT MEASURING 18 MM INTERNALLY, WITH 7MM OFFSET OPENINGS ON THE RIGHT AND LEFT SIDES WITH A SEPTAL WIDTH OF 8MM. THE LEFT SIDE OF THE DEFECT SHOWED SUFFICIENT RIMS; HOWEVER, THE RIGHT SIDED OPENING WAS MILDLY HIGHER AND NEARER TO THE TRICUSPID VALVE LEAFLET. AFTER PLACEMENT OF A GUIDE WIRE, THE PHYSICIAN DETERMINED THEY WANTED TO SWITCH OUT THE WIRE, AND GO BARE ACROSS THE SEPTUM WITH A NEW NON-ABBOTT WIRE. AFTER PLACEMENT OF THE NEW WIRE THE PHYSICIAN WAS HAVING DIFFICULTY CROSSING THE DEFECT WITH THE SHEATH AND DILATOR. THERE WAS A RESISTANCE FELT AND THEN DECIDED TO ATTEMPT AN ANTEGRADE APPROACH. THE PHYSICIAN THEN WENT TO AN ANTEGRADE APPROACH, AT THIS POINT THE WIRE HAD STILL BEEN BARE ACROSS THE VSD AT THE MD'S REQUEST. THE DELIVERY SYSTEM CROSSED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469615 ↗
• MalfunctionJan 30, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER VSD MUSCULAR OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYMENT, IT WAS NOTED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE AND TOOK FORM OF A COBRA-LIKE DEFORMATION. THEREFORE, THE PHYSICIAN HAD TO RETRIEVE IT BACK AND 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 24223767 ↗
• MalfunctionAug 29, 2025Device Damaged by Another Device; Device Damaged by Another Device

  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 22926005 ↗
• MalfunctionJun 19, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 10MM AMPLATZER VSD MUSCULAR OCCLUDER WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE DEVICE PHYSICIAN NOTED THAT THE DEVICE WAS NOT TAKING ITS PROPER SHAPE AND WAS RETRIEVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. NO DEVICE WAS IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19569546 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, "NOVEL USE OF A LEFT ATRIAL APPENDAGE OCCLUDER FOR PARAVALVULAR LEAK CLOSURE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 40-YEAR-OLD MALE PATIENT WITH OBESITY, DIABETES MELLITUS, AND A PRIOR SURGICAL MITRAL VALVE REPLACEMENT PROCEDURE WITH AN UNKNOWN MECHANICAL VALVE. IT WAS REPORTED THAT ON AN UNKNOWN DARE, TWO 10MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDERS WERE IMPLANTED TO CLOSE A PARAVALVULAR LEAK (PVL) OF THE UNKNOWN MECHANICAL MITRAL VALVE. IT WAS LATER REPORTED, THE PATIENT DEVELOPED HEMOLYSIS, PIGMENT NEPHROPATHY, AND RENAL FAILURE REQUIRING HEMODIALYSIS. REPEAT ECHOCARDIOGRAPHY SHOWED MODERATE RESIDUAL PVL BETWEEN THE TWO IMPLANTED OCCLUDERS. A DECISION WAS MADE TO EXPLANT THE TWO VSD OCCLUDERS. SUBSEQUENT ATTEMPTS TO CLOSE THE PVL WERE MADE WITH A 10MM, 12MM, AND 13MM AMPLATZER SEPTAL OCCLUDERS BUT ALL DEVICES WERE RETRIEVED. A DECISION WAS MADE TO IMPLANT A 31MM BOSTON SCIENTIFIC WATCHMAN FLX OCCLUDER TO TREAT THE PVL. SEVERAL COILS, TWO 10X35MM PENUMBRA RUBY AND ONE 8 X40MM PENUMBRA 400, WERE ADDITIONALLY IMPLANTED TO MINIMIZE EMBOLIZATION OF THE OCCLUDER. [THE PRIMARY AND CORRESPONDING AUTHOR WAS JAMES MCCABE, DIVISION OF CAR

  Patient problems: Hemolysis; Renal Failure

  MAUDE report 18955435 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, "NOVEL USE OF A LEFT ATRIAL APPENDAGE OCCLUDER FOR PARAVALVULAR LEAK CLOSURE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 40-YEAR-OLD MALE PATIENT WITH OBESITY, DIABETES MELLITUS, AND A PRIOR SURGICAL MITRAL VALVE REPLACEMENT PROCEDURE WITH AN UNKNOWN MECHANICAL VALVE. IT WAS REPORTED THAT ON AN UNKNOWN DARE, TWO 10MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDERS WERE IMPLANTED TO CLOSE A PARAVALVULAR LEAK (PVL) OF THE UNKNOWN MECHANICAL MITRAL VALVE. IT WAS LATER REPORTED, THE PATIENT DEVELOPED HEMOLYSIS, PIGMENT NEPHROPATHY, AND RENAL FAILURE REQUIRING HEMODIALYSIS. REPEAT ECHOCARDIOGRAPHY SHOWED MODERATE RESIDUAL PVL BETWEEN THE TWO IMPLANTED OCCLUDERS. A DECISION WAS MADE TO EXPLANT THE TWO VSD OCCLUDERS. SUBSEQUENT ATTEMPTS TO CLOSE THE PVL WERE MADE WITH A 10MM, 12MM, AND 13MM AMPLATZER SEPTAL OCCLUDERS BUT ALL DEVICES WERE RETRIEVED. A DECISION WAS MADE TO IMPLANT A 31MM BOSTON SCIENTIFIC WATCHMAN FLX OCCLUDER TO TREAT THE PVL. SEVERAL COILS, TWO 10X35MM PENUMBRA RUBY AND ONE 8 X40MM PENUMBRA 400, WERE ADDITIONALLY IMPLANTED TO MINIMIZE EMBOLIZATION OF THE OCCLUDER. [THE PRIMARY AND CORRESPONDING AUTHOR WAS JAMES MCCABE, DIVISION OF CAR

  Patient problems: Hemolysis; Renal Failure

  MAUDE report 18899022 ↗
• InjuryAug 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE ARTICLE, ¿A CHALLENGING INTERVENTIONAL PROCEDURE: TRANSCATHETER CLOSURE OF TUBULAR PATENT DUCTUS ARTERIOSUS IN PATIENTS WITH PULMONARY HYPERTENSION¿, WAS REVIEWED. THE ARTICLE PRESENTS A CASE STUDY OF AN 9-MONTH-OLD, 7.5KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DUCTUS DIAMETER = 9.2MM, AMPULLA DIAMETER = 13.4MM, DUCTAL LENGTH = 9.8MM. IT WAS REPORTED ON AN UNKNOWN DATE, A 10MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DUCT WAS CHOSEN FOR IMPLANT TO OCCLUDE A PDA. AFTER IMPLANT, IT WAS NOTICED THE PATIENT HAD A LEFT PULMONARY ARTERY (LPA) STENOSIS THAT WAS RESISTANT TO BALLOON DILATION. A DECISION WAS MADE TO IMPLANT A STENT IN THE LPA TO TREAT STENOSIS. [THE PRIMARY AND CORRESPONDING AUTHOR IS ILKER KEMAL YUCEL, DEPARTMENT OF PEDIATRIC CARDIOLOGY, UNIVERSITY OF HEALTH SCIENCES DR. SIYAMI ERSEK THORACIC AND CARDIOVASCULAR SURGERY TRAINING AND RESEARCH HOSPITAL, ISTANBUL, TURKEY, [email protected]]. PERIPROCEDURAL COMPLICATIONS INCLUDED SURGICAL INTERVENTION, PULMONARY OCCLUSION, IMPROPER USE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17541366 ↗
• MalfunctionDec 12, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 10MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER WAS SELECTED FOR PROCEDURE USING A NON-ABBOTT DELIVERY SHEATH. NO ISSUES OR ANOMALIES WERE REPORTED DURING DEVICE PREPARATION. IT WAS NOTED THAT DURING PROCEDURE, VIA FLUOROSCOPY, THAT THE OCCLUDER EXHIBITED A BULBOUS DEFORMATION WHEN BEING DEPLOYED. THE 10MM AMPLATZER MUSCULAR VSD OCCLUDER WAS NEVER FULLY RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. NO ANGULATION OR KINK WAS OBSERVED WIT THE DELIVERY SYSTEM. THE IMPLANT PROCEDURE WAS ULTIMATELY ABORTED AND NO DEVICE WAS IMPLANTED. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15964424 ↗
• MalfunctionMar 1, 2020Mechanical Problem; Retraction Problem; Mechanical Problem; Retraction Problem

  RELATED MANUFACTURER REFERENCE NUMBER 2135147-2020-00087. ON (B)(6) 2020, AN 8MM AMPLATZER MUSCULAR VSD WAS ATTEMPTED TO BE IMPLANTED. IT WAS MIS-SIZED TOO SMALL AND EXCHANGED FOR A 10MM AMPLATZER MUSCULAR VSD OCCLUDER (LOT # 6925807) WITH A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. WHEN POSITIONING THE DEVICE, IT WAS DETERMINED TO BE MI-SIZED TOO SMALL. WHEN ATTEMPTING TO RETRACT THE DEVICE, THE DEVICE WOULD NOT RE-SHEATH NOR RETRACT INTO THE 6F DELIVERY SHEATH AND A VASCULAR ISSUE OCCURRED WITH HEMATOMA AT THE GROIN. THE DEVICE AND THE DELIVERY SYSTEM WAS REMOVED AND THE DELIVERY SYSTEM WAS EXCHANGED FOR AN 8F TORQVUE 45/80 DELIVERY SYSTEM (LOT # UNKNOWN) AND A NEW 10MM MUSCULAR VSP (LOT # 6942246). THE PHYSICIAN NOTED THAT THE PATIENT HAD A TORTUROUS ANATOMY AND THERE WAS NO KINKS NOTED ON THE FIRST DELIVERY SYSTEM (LOT # 6271477). THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS STABLE DURING AND POST PROCEDURE.

  Patient problems: Hematoma

  MAUDE report 9772695 ↗