Amplatzer™ 9-VSD-MUSC-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00811806011790), received between Jun 6, 2019 and Jul 14, 2026 — classified as 1 death, 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT (B)(6) 2026, AN UNKNOWN SIZE AMPLATZER MUSCULAR VSD OCCLUDER WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2026, THE OCCLUDER WAS SUCCESSFULLY EXPLANTED.

  Patient problems: Hemolysis; Insufficient Information

  MAUDE report 25817813 ↗
• MalfunctionSep 5, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F NON-ABBOTT SHEATH. DURING PROCEDURE, WHILE DEPLOYMENT THE PHYSICIAN NOTED THAT THE DEVICE WAS NOT TAKING ITS PROPER SHAPE AND 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 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 22977160 ↗
• DeathAug 13, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6MM AMPLATZER VSD MUSCULAR OCCLUDER WAS SELECTED FOR IMPLANT. PRIOR TO VSD PROCEDURE, AN UNKNOWN SIZED TRICLIP WAS IMPLANTED WITH NO REPORTED ISSUES. THE VSD OCCLUDER WAS IMPLANTED TO CLOSE A MITRAL VALVULAR LEAK. ON (B)(6) 2025, THE PATIENT PASSED AWAY DUE TO HEMOLYSIS.

  Patient problems: Hemolysis

  MAUDE report 22795050 ↗
• InjuryMar 21, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6MM AMPLATZER VSD MUSCULAR OCCLUDER WAS SELECTED FOR AN IMPLANT RELATING TO CONGENITAL VENTRICULAR SEPTAL DEFECT. DURING THE PROCEDURE, THE DEVICE EMBOLIZED INTO THE RIGHT VENTRICLE AFTER BEING RELEASED INTO THE INTERVENTRICULAR SEPTUM. THE PHYSICIAN BELIEVE THAT THE EMBOLIZATION WAS CAUSED BY POSSIBLY LARGER FETUS, IRREGULARITY IN THE SEPTUM. THE PATIENT WAS TAKEN TO OPEN HEART SURGERY FOR THE REMOVAL OF THE DEVICE AND CLOSING THE DEFEAT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952376 ↗
• InjuryMar 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR A HIGH MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) USING AN UNKNOWN SIZE ABBOTT DELIVERY SYSTEM. DURING PROCEDURE, WHEN THE DEVICE PLACED IN THE PATIENT AND RELEASED, BUT IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) DISC WAS TRAPPED TRICUSPID VALVE (TV) CHORDAE TENDINAE. THE DEVICE WAS NOTED TO BE OVERSIZED FOR THE DEFECT. THE DEVICE REMOVAL VIA TRANSCATHETER SNARE WAS DIFFICULT AS THE DEFECT WAS SMALL, BUT THE DEVICE WAS SUCCESSFULLY RETRIEVED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PLAN WAS MADE TO LATER SURGICALLY CLOSE THE DEFECT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924024 ↗
• InjuryAug 15, 2019Retraction Problem; Retraction Problem

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2019-00256. ON (B)(6) 2019, AN AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT. THE DEVICE WAS DEPLOYED BUT DIDN'T FIT THE VENTRICULAR SEPTAL DEFECT. THE DEVICE WAS ATTEMPTED TO BE RETRACTED, BUT THE OCCLUDER DIDN'T COLLAPSE AND RETRACT INTO THE DELIVERY SHEATH. THE TIP OF THE DELIVERY SHEATH KEPT FOLDING IN ON ITSELF. MEANWHILE, THE PATIENT WENT INTO COMPLETE HEART BLOCK AND BECAME HYPOTENSIVE. THE OCCLUDER AND DELIVERY SYSTEM WERE WITHDRAWN FROM THE PATIENT WITHOUT COLLAPSING THE OCCLUDER. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS SENT TO THE PEDIATRIC INTENSIVE CARE UNIT FOR CONTINUED MONITORING. THE HEART BLOCK RESOLVED WITHOUT TREATMENT.

  Patient problems: Complete Heart Block; Low Blood Pressure/ Hypotension

  MAUDE report 8896643 ↗
• InjuryJun 6, 2019Positioning Problem; Positioning Problem

  ON (B)(6) 2019, A 4/6MM AMPLATZER DUCT OCCLUDER II AND A 6MM AMPLATZER MUSCULAR VSD OCCLUDER WERE SELECTED TO CLOSE AN AORTIC TO RIGHT VENTRICULAR FISTULA. WHILE ATTEMPTING TO DEPLOY BOTH DEVICES, THE PHYSICIAN REPORTED THAT BOTH DEVICES WERE UNSTABLE. THE CASE WAS ABORTED DUE TO DIFFICULTY CLOSING THE DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8677037 ↗