IMPEDE Embolization Plug IMP-05 (UDI B054IMP051)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B054IMP051), received between Dec 30, 2021 and Dec 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS IMP-05 WAS USED TO PERFORM A IIA EMBOLIZATION IN A COMMON ILIAC ARTERY ANEURYSM (CIAA). ACCESS TO THE TARGET SITE WAS THROUGH THE SUPERIOR GLUTEAL ARTERY USING A JUDKINS CATHETER 4FR (0.038 INCH INNER DIAMETER). THE PHYSICIAN USED A RADIFOCUS GUIDEWIRE (0.035 INCH OUTER DIAMETER) TO DELIVER THE IMP-05 THROUGH THE CATHETER. THE IMPEDE PROXIMAL MARKERBAND COULD NOT BE CONFIRMED IN THE CATHETER UNDER FLUOROSCOPY DURING DELIVERY, EVEN WHEN THE RADIFOCUS GUIDEWIRE WAS PULLED BACK FOR BETTER VISIBILITY. AFTER THE ANCHOR COIL PORTION OF THE IMP-05 WAS DEPLOYED, THE PHYSICIAN WAS THEN ABLE TO VISUALIZE THE IMPEDE PROXIMAL MARKERBAND UNDER FLUOROSCOPY, AND FOUND THAT THE FOAM HAD SEPARATED FROM THE ANCHOR COIL. THE PHYSICIAN THEN CHOSE TO DELIVER BOTH THE ANCHOR COIL AND THE FOAM, SEPARATE, INTO THE BLOOD VESSEL. ANOTHER COIL (NOT MANUFACTURED BY SMM) WAS THEN DELIVERED, COMPLETE EMBOLIZATION WAS ACHIEVED AND THE OPERATION WAS COMPLETED. THIS EVENT DID NOT RESULT IN ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122570 ↗