Amplatzer™ 9-VSD-MUSC-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00811806011837), received between Jun 18, 2018 and Mar 3, 2026 — classified as 1 death, 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 18, 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.

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

  IT WAS REPORTED THAT ON (B)(6) 2026 2026, A 14MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR A PROCEDURE USING AN UNKNOWN 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497870 ↗
• MalfunctionAug 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM NAVITOR VALVE WAS IMPLANTED. THERE WAS NO DIFFICULTY DURING OR AFTER VALVE IMPLANTATION. ON (B)(6) 2024, THE PATIENT HAD A MEMBRANOUS SEPTUM RUPTURE AND RETURNED FOR TREATMENT. IT WAS BELIEVED THAT THE CAUSE OF THE VENTRICULAR MEMBRANOUS SEPTUM RUPTURE WAS DUE TO THE ANNULUS STENT OF THE VALVE. DURING THE VENTRICULAR SEPTAL DEFECT CLOSURE, AN ARTERIO-VENOUS LOOP WAS PERFORMED, AND A 14MM AMPLATZER MUSCULAR VSD OCCLUDER WAS PLACED. THE 14MM DEVICE WAS TOO SMALL, AND A LARGE TRICUSPID LEAK APPEARED. THE TRICUSPID LEAK WAS BELIEVED TO BE POSSIBLY DUE TO A BREAK IN THE CHORDAE FOLLOWING THE REALIZATION OF THE AV LOOP. THE 14MM DEVICE WAS REMOVED, AND THE TRICUSPID REGURGITATION RESOLVED. THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF A 18MM AMPLATZER MUSCULAR VSD OCCLUDER USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (ATV) FOR A SATISFACTORY RESULT.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 20017555 ↗
• InjuryNov 7, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 14MM AMPLATZER VSD MUSCULAR OCCLUDER WAS IMPLANT IN A PATIENT. THE DEVICE WAS EMBOLIZED A FEW MINUTES AFTER IMPLANT (30 MINUTES POST-PROCEDURE). NO INTERVENTION, DEVICE STILL IN THE SMALL ANEURYSM. THE PATIENT IS STABLE, ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088204 ↗
• DeathOct 5, 2023Off-Label Use; Patient Device Interaction Problem; Off-Label Use; Patient Device Interaction Problem

  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) TO TREAT A PATIENTS MITRAL PARAVALVULAR LEAK (PVL). THE PATIENT CONDITION WAS NOT STABLE DUE TO CARDIOGENIC SHOCK. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION. THERE WAS NO KINK NOTICED ON THE DELIVERY SYSTEM BUT THERE WAS ANGULATION ON THE DELIVERY SYSTEM DUE TO ANGLE OF APPROACH. 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. THERE WAS NO KINK NOTICED ON THE DELIVERY SYSTEM BUT THERE WAS ANGULATION ON THE DELIVERY SYSTEM DUE TO ANGLE OF APPROACH. A NEW 14MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED USING A AMPLATZER TORQVUE DELIVERY SYSTEM. THE 14MM DEVICE DIDN'T RESOLVE THE PATIENTS PVL. THE PATIENT WAS NOT HEMODYNAMICALLY STABLE DURING AND AFTER THE PROCEDURE. ON (B)(6) 2023, THE PATIENT WAS PASSED AWAY DUE TO SEPSIS. THE PATIENT HAD M

  Patient problems: Insufficient Information

  MAUDE report 17880496 ↗
• 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 17784997 ↗
• InjuryJun 12, 2022Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED A 14MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT ON (B)(6) 2022. THE DEVICE WAS SIZED BY FLUOROSCOPY. DURING PROCEDURE, POST DEPLOYMENT, THE DEVICE IMMEDIATELY EMBOLIZED INTO THE PULMONARY ARTERY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE/ A SNARE WAS USED FOR RETRIEVAL AND THE DEVICE WAS REMOVED. A REPLACEMENT DEVICE WAS NOT USED, THE PROCEDURE WAS ABORTED. THE PATIENT'S STATUS WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14671998 ↗
• InjuryFeb 17, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2022, A 14MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT. A FEW SECONDS AFTER RELEASE THE DEVICE EMBOLIZED INTO THE TRICUSPID VALVE AND WAS NOT ABLE TO BE SNARED. A FEW DAYS PRIOR, THE PATIENT SUFFERED MYOCARDIAL INFRACTION AND DUE TO THE PATIENT'S OVERALL HEALTH CONDITION IT WAS DECIDED TO LEAVE THE OCCLUDER AND NOT EXPLANT IT UNTIL THE PATIENT RECOVERS. IT IS THOUGHT THAT THE EMBOLIZATION OCCURRED DUE TO THE CARDIAC INFRACTION AND THE TISSUE OF THE VENTRICLE SEPTUM WAS PERISHED AND CAUSED A VENTRICULAR SEPTAL DEFECT (VDS). THE RIMS OF THE SEPTUM WERE TO WEAK TO STABILIZE THE OCCLUDER. THE PHYSICIAN REPORTED THAT THIS WAS A KNOWN POSSIBILITY AFTER THE RECENT INFRACTION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE HEALTH CONSEQUENCES AND THE PATIENT WAS REPORTED TO BE TO RECOVERING. OPERATIVE NOTES AND ECHO IMAGES WERE REQUIRED BUT CANNOT BE PROVIDED DUE TO DATA SECURITY RESTRICTIONS.

  Patient problems: Myocardial Infarction

  MAUDE report 13548258 ↗
• InjuryOct 1, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2019, A 14 MM AMPLATZER MUSCULAR VSD OCCLUDER WAS IMPLANTED FOLLOWING A PUSH-PULL TEST. SEVERAL HOURS AFTER THE CASE, THE DEVICE EMBOLIZED. THE PATIENT WAS RETURNED TO THE CATH LAB, THE DEVICE WAS RETRIEVED AND A 18 MM OCCLUDE WAS IMPLANTED SUCCESSFULLY. THE USER BELIEVES THE 14 MM DEVICE WAS AN INADEQUATE SIZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9142562 ↗
• InjurySep 24, 2018Unintended Movement; Unintended Movement

  ON (B)(6) 2018, A 12MM AMPLATZER MUSCULAR VSD OCCLUDER WAS NOT IMPLANTED DUE TO SIZING. THE DEVICE WAS EXCHANGED FOR A 14MM AMPLATZER MUSCULAR VSD OCCLUDER (LOT NUMBER: 5008417). AFTER RELEASING THE OCCLUDER, THE DEVICE EMBOLIZED TO THE PATIENT'S LUNG AND THE PATIENT WAS REINTUBATED AND THE DEVICE WAS RETRIEVED. A 12-10MM AMPLATZER DUCT OCCLUDER (LOT NUMBER: 479522) WAS SELECTED FOR IMPLANT, HOWEVER IT WAS REMOVED PRIOR TO RELEASE DUE TO SIZING. AN 18MM AMPLATZER MUSCULAR VSD OCCLUDER (LOT NUMBER: 4959869) WAS SELECTED FOR IMPLANT, BUT IT WAS ALSO REMOVED PRIOR TO RELEASE DUE TO SIZING. AND A 22/18MM AMPLATZER VASCULAR PLUG II (LOT NUMBER: 5335493) WAS SELECTED FOR IMPLANT, HOWEVER, IT WAS NOT RELEASED DUE TO SIZING. THERE WERE NO PATIENT CONSEQUENCES REPORTED AND SURGICAL CLOSURE WILL BE SCHEDULED ON A LATER DATE.

  Patient problems: No Information

  MAUDE report 7901802 ↗
• InjuryJun 18, 2018Migration or Expulsion of Device; Unintended Movement; Migration or Expulsion of Device; Unintended Movement

  ON (B)(6) 2018, A 14MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR A FINAL ATTEMPT FOR CLOSURE OF A PROSTHETIC PVL IN A PATIENT WITH RV FAILURE WHO WAS CONSIDERED INOPERABLE. CLOSURE. DURING IMPLANT, THE DEVICE APPEARED STABLE, HOWEVER, SOME MOTION OF THE PROSTHETIC VALVE WAS NOTED ON TOE. THE IMPLANT WAS UNEVENTFUL AND ON (B)(6) 2018, THE PATIENT WAS RETURNED TO THEIR LOCAL HOSPITAL. ASSESSMENT AT THE LOCATION HOSPITAL ON (B)(6) 2018, CONFIRMED THE DEVICE EMBOLIZED INTO THE LEFT ATRIUM. DUE TO PATIENT CLINICAL STATUS, THERE WAS FURTHER INTERVENTION CARRIED OUT. A FEW DAYS FOLLOWING THE TRANSFER TO THE LOCAL HOSPITAL, THE PATIENT GRADUALLY DECLINED DUE TO HEART FAILURE AND DIED.

  Patient problems: Death

  MAUDE report 7611724 ↗