i-ED COIL 390-0101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04540778176423), received between Mar 23, 2026 and Mar 26, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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 16, 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.

• InjuryMar 26, 2026Migration

  WE, MANUFACTURER KANEKA, FOUND THIS REPORT AS STUDY LITERATURE SURVEY, TITLE: A CASE OF SUCCESSFUL RETRIEVAL USING A STENT RETRIEVER FOR COIL MIGRATION DURING PARENT ARTERY OCCLUSION, JOURNAL: CJC OPEN, 2024. [ABSTRACT] COIL MIGRATION DURING CEREBRAL ANEURYSM EMBOLIZATION IS UNCOMMON BUT POSES SIGNIFICANT TECHNICAL CHALLENGES. WE REPORT A 58-YEAR-OLD WOMAN WITH SUBARACHNOID HEMORRHAGE CAUSED BY A SMALL DISSECTING ANEURYSM OF THE DISTAL VERTEBRAL ARTERY, LOCATED BEYOND THE ORIGIN OF THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA). PARENT ARTERY OCCLUSION WAS PERFORMED. AFTER COMPLETION OF COIL EMBOLIZATION, SEVERAL FINISHING COILS MIGRATED INTO THE PICA DURING MICROCATHETER WITHDRAWAL. A MICROCATHETER WAS NAVIGATED INTO THE PICA, A STENT RETRIEVER WAS DEPLOYED, AND THE MIGRATED COILS WERE CAPTURED BETWEEN THE STENT RETRIEVER AND MICROCATHETER AND REMOVED EN BLOC. WHILE A SNARE CATHETER IS GENERALLY THE FIRST-LINE OPTION FOR DISTAL COIL RETRIEVAL, A STENT RETRIEVER CAN BE AN EFFECTIVE ALTERNATIVE WHEN A MICROCATHETER CAN BE ADVANCED INTO SMALL OR TORTUOUS VESSELS. 15 I-ED COILS IN TOTAL WERE PLACED IN THE ANUERYSM, BUT WHILE WITHDRAWING THE CONCOMITANTLY USED MICROCATHETER, SEVERAL I

  Patient problems: Movement Disorder

  MAUDE report 24699880 ↗
• InjuryMar 23, 2026Migration

  WE, MANUFACTURER KANEKA, FOUND THIS REPORT AS STUDY LITERATURE SURVEY, TITLE: A CASE OF SUCCESSFUL RETRIEVAL USING A STENT RETRIEVER FOR COIL MIGRATION DURING PARENT ARTERY OCCLUSION, JOURNAL: CJC OPEN, 2024. [ABSTRACT]: COIL MIGRATION DURING CEREBRAL ANEURYSM EMBOLIZATION IS UNCOMMON BUT POSES SIGNIFICANT TECHNICAL CHALLENGES. WE REPORT A 58-YEAR-OLD WOMAN WITH SUBARACHNOID HEMORRHAGE CAUSED BY A SMALL DISSECTING ANEURYSM OF THE DISTAL VERTEBRAL ARTERY, LOCATED BEYOND THE ORIGIN OF THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA). PARENT ARTERY OCCLUSION WAS PERFORMED. AFTER COMPLETION OF COIL EMBOLIZATION, SEVERAL FINISHING COILS MIGRATED INTO THE PICA DURING MICROCATHETER WITHDRAWAL. A MICROCATHETER WAS NAVIGATED INTO THE PICA, A STENT RETRIEVER WAS DEPLOYED, AND THE MIGRATED COILS WERE CAPTURED BETWEEN THE STENT RETRIEVER AND MICROCATHETER AND REMOVED EN BLOC. WHILE A SNARE CATHETER IS GENERALLY THE FIRST-LINE OPTION FOR DISTAL COIL RETRIEVAL, A STENT RETRIEVER CAN BE AN EFFECTIVE ALTERNATIVE WHEN A MICROCATHETER CAN BE ADVANCED INTO SMALL OR TORTUOUS VESSELS. 15 I-ED COILS IN TOTAL WERE PLACED IN THE ANUERYSM, BUT WHILE WITHDRAWING THE CONCOMITANTLY USED MICROCATHETER, SEVERAL

  Patient problems: Paralysis

  MAUDE report 24659660 ↗