IMPEDE Embolization Plug IMP-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810041650016), received between Jan 4, 2022 and Feb 11, 2026 — classified as 3 malfunctions.

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

• MalfunctionFeb 11, 2026Migration

  DURING AN ARTERIOVENOUS (AV) SHUNT CASE ON (B)(6) 2025 IN TAIWAN, THE PHYSICIAN IMPLANTED AN IMP-07 DEVICE NEAR THE WRIST OF THE PATIENT. WHEN THE PATIENT RETURNED FOR A FOLLOW-UP ON (B)(6) 2026 DUE TO CONCERNS OF SWELLING, IT WAS FOUND THE DEVICE HAD MIGRATED PROXIMALLY (UP TOWARDS THE ELBOW AREA) WHICH OCCLUDED THE MAIN VESSEL. THE PHYSICIAN PERFORMED A CUT-DOWN TO REMOVE THE IMP-07 DEVICE AND IT REMAINS EXPLANTED FROM THE PATIENT. NO SERIOUS CLINICAL EVENT OCCURRED TO THE PATIENT AND THE PATIENT IS STABLE.

  Patient problems: Peripheral Edema

  MAUDE report 24318996 ↗
• MalfunctionJan 20, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTED DATE OF THE EVENT IS (B)(6) 2021, ALTHOUGH THE INITIAL PROCEDURE TOOK PLACE ON (B)(6) 2021. ON (B)(6) 2021, A 2-DEBRANCH TEVAR WAS BEING PERFORMED AND AN IMP-10 AND IMP-07 WAS USED TO EMBOLIZE THE LEFT SUBCLAVIAN ARTERY (LSCA) AT THE SAME TIME. THE IMP-10 WAS INTRODUCED INTO THE BODY FIRST, FOLLOWED BY THE IMP-07 IN PARALLEL; BOTH DEVICES WERE REPORTED TO BE DELIVERED INTO THE TARGET SITE. THE OPERATION WAS COMPLETED, ALTHOUGH IT WAS NOT CONFIRMED AT THE TIME THAT EMBOLIZATION OF THE LSCA WAS ACHIEVED WITH THE IMP-10 DEVICE. ON (B)(6) 2021, DURING THE POST-OPERATIVE EXAMINATION USING CONTRAST-ENHANCED COMPUTED TOMOGRAPHY, A TYPE II ENDOLEAK WAS FOUND AT THE LSCA. ON (B)(6) 2021, AN OPERATION WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK FOUND DURING THE POST-OPERATIVE EXAMINATION USING ADDITIONAL NON-SMM EMBOLIC COIL DEVICES (3 INTERLOCK COILS FROM BOSTON SCIENTIFIC). THESE DEVICES WERE DEPLOYED TO THE LSCA FROM THE VICINITY OF THE IMPEDE EMBOLIZATION PLUGS, USING AN IMPRESS 5FR DIAGNOSTIC CATHETER FROM MERIT MEDICAL. IT WAS CONFIRMED THAT THE INTERLOCK COILS WERE DELIVERED, COMPLETE EMBOLIZATION WAS ACHIEVED, THE TYPE II ENDOLEAK HAD DISAPPEARED, AND THE OPERATION WAS C

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13311458 ↗
• MalfunctionJan 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT UNDERWENT BYPASS SURGERY TO TREAT A POPLITEAL ANEURYSM. DUE TO THE PRESENCE OF A PATENT POPLITEAL VESSEL (7-8 MM DIAMETER), THE PHYSICIAN ATTEMPTED EMBOLIZATION VIA DELIVERY OF AN IMP-07 DEVICE. AFTER OBSERVING NO VESSEL OCCLUSION, AN IMP-FX-08 DEVICE WAS DELIVERED TO THE SAME TARGET AREA. TEN MINUTES AFTER THE IMP-FX DELIVERY, RESIDUAL FLOW WAS STILL OBSERVED WHICH RESULTED IN SEVERAL COOK COILS BEING USED TO COMPLETE THE CASE. NO ADVERSE EVENT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13160195 ↗