Amplatzer™ Post Infarct Muscular VSD Occluder (REF 9-VSDMPIHDE-016)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067028105), received between Mar 31, 2022 and Jan 27, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE HAD A COBRA HEAD ON THE RIGHT DISC AFTER DEPLOYMENT. THE DEVICE WAS RECAPTURED AND TAKEN OUT OF THE BODY. 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. A NEW UNKNOWN DEVICE 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 21242577 ↗
• MalfunctionMar 31, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THIS EVENT IS BEING REPORTED FOR MALFUNCTION DUE TO THE DEFORMATION ON THE 16MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER. THE PERICARDIAL EFFUSION/CARDIAC TAMPONADE IS RELATED TO THE NON-ABBOTT 0.035 GLIDE CATHETER. IT WAS REPORTED ON (B)(6) 2022, A 16MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT FOR POST INFARCT VENTRICULAR SEPTAL DEFECT (PI VSD). IT WAS NOTED THAT APPROXIMATELY 6 WEEKS PRIOR TO IMPLANT PROCEDURE THE PATIENT EXPERIENCED A SIGNIFICANT LEFT VENTRICULAR (LV) MYOCARDIAL INFARCTION RESULTING IN A FORMATION OF PI VSD NEAR THE APEX OF BOTH THE LEFT AND RIGHT VENTRICLES. THE PATIENT ALSO SUFFERED A NUMBER OF PERICARDIAL EFFUSIONS THAT WERE NOTED IMMEDIATELY FOLLOWING THE INFARCTION. DURING DEPLOYMENT A COBRA DEFORMATION WAS NOTED ON THE INITIAL ATTEMPT. THE DEVICE WAS RECAPTURED AND A SECOND DEPLOYMENT WAS ATTEMPTED HOWEVER A DEFORMATION WAS NOTED AGAIN. DURING THIS TIME, UNDER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AN EFFUSION WAS NOTED AND WAS GETTING LARGER. IT WAS DECIDED TO RECAPTURE THE DEVICE AGAIN AND DEPLOY FOR A THIRD TIME HOWEVER, THE COBRA SHAPE APPEARED AGAIN AND THE PROXIMAL DISK WAS STILL CAPTURED IN THE SHEATH. THE PATIENT BLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967308 ↗