Amplatzer™ Post Infarct Muscular VSD Occluder (REF 9-VSDMPIHDE-018)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067028112), received between Nov 18, 2020 and Sep 29, 2025 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER PI MUSC VSD WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE FORMED A COBRA SHAPE ON THE RIGHT VENTRICULAR(RV) DISC. FOLLOWING THAT, PHYSICIAN CHOSE A 22MM AMPLATZER VASCULAR PLUG II , BUT THE DEVICE WAS PULLED THROUGH THE DEFECT AND WAS REMOVED BEFORE RELEASE FROM CABLE AS THE PHYSICIAN FELT IT WAS SMALL FOR THE DEFECT. THE PROCEDURE WAS COMPLETED USING A NEW 24MM AMPLATZER PI MUSC VSD WITH SATISFACTORY CLOSURE. IT IS REPORTED THAT THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23174976 ↗
• DeathFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 18MM AMPLATZER PI MUSC VSD FOR EMERGENT IMPLANT IN A PATIENT WHO HAD CARDIOGENIC SHOCK WITH VENTRICULAR SEPTAL DEFECT POST MYOCARDIAL INFARCTION ON (B)(6) 2023. THE IMPLANT PROCEDURE WAS SUCCESSFUL AND DEVICE WAS IMPLANTED IN STABLE POSITION. PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY ON (B)(6) 2024. ON (B)(6) 2023, THE PATIENT WAS RE-ADMITTED IN CARDIOGENIC SHOCK AND BRADYCARDIA. THE PATIENT EXPIRED ON THE SAME DAY. THE DEATH IS NOT THOUGHT TO BE DEVICE RELATED.

  Patient problems: Bradycardia; Shock

  MAUDE report 18711658 ↗
• MalfunctionNov 18, 2020Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  ON (B)(6) 2020 THE PHYSICIAN ATTEMPTED TO PLACE A 9-VSDMPIHDE-018. HOWEVER, THE PLACEMENT WAS UNSUCCESSFUL SO THE DEVICE WAS REMOVED AND CASE ABORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10862796 ↗