IMPEDE Embolization Plug IMP-05 (UDI 00810041650009)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810041650009), received between Dec 22, 2021 and Nov 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2023Malposition of Device; Malposition of Device

  THE PLAN FOR THIS PROCEDURE WAS THAT THE PATIENT WAS GOING TO BE TREATED IN STAGES SURGICALLY. THIS FIRST STAGE INVOLVED EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY (IMA) WITH AN IMP-05 DEVICE. THE PHYSICIAN USED A TERUMO 4FR GLIDECATH (0.038"/0.97MM) TO DELIVER THE IMP-05 DEVICE IN THE TARGET LESION (IMA), BUT WHEN IT WAS ATTEMPTED TO BE DEPLOYED INTO THE VESSEL, IT WAS CLOSE TO THE ORIGIN OF THE VESSEL WITHIN THE AAA SAC, AND IT WAS DEPLOYED IN A NON-TARGET FASHION INTO THE AAA SAC. THE PHYSICIAN NOTED THAT THE ANCHOR COIL HAD ENTERED THE IMA SEVERAL CENTIMETERS BUT WAS "VERY STIFF AND THE DEVICE RECOILED AND BOUNCED INTO THE AAA SAC." THE PHYSICIAN DECIDED TO LEAVE THE IMP-05 PLUG IN PLACE INSIDE THE AAA SAC AND THEN EVAR WAS PERFORMED WITH A STENT GRAFT DEPLOYMENT THAT SECURED THE IMP-05 PLUG BETWEEN THE STENT AND SAC WALL. THE PROCEDURE WAS COMPLETED WITH STRYKER TARGET AND BOSTON SCIENTIFIC INTERLOCK COILS FOR IMA AND IIA EMBOLIZATION AND EVAR STENTING IN THE AAA SAC. THE IMP-05 PLUG REMAINS IMPLANTED IN ITS LOCATION IN THE AAA SAC. NO SERIOUS ADVERSE EVENT TO THE PATIENT WAS REPORTED.

  Patient problems: Foreign Body Embolism

  MAUDE report 18163147 ↗
• MalfunctionDec 22, 2021Product Quality Problem; Product Quality Problem

  THE PHYSICIAN PLANNED TO USE AN IMP-05 DEVICE TO EMBOLIZE AN IMA. HOWEVER, PRIOR TO USING THE DEVICE, IT WAS CHECKED UNDER FLUOROSCOPY WHERE IT WAS FOUND THAT ONLY THE ANCHOR COIL WAS PRESENT AND NOT THE FOAM PLUG PORTION OF THE DEVICE. TO CONFIRM THIS, THE PHYSICIAN PUSHED THE DEVICE OUT OF THE INTRODUCER, ONTO THE BENCH, USING A GUIDEWIRE AND THE FOAM PLUG WITH MARKERBAND PORTION OF THE DEVICE COULD NOT BE FOUND. THERE WAS NO IMPACT TO THE PATIENT AS THE PROCEDURE WAS COMPLETED USING ANOTHER IMP-05 DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061127 ↗