i-ED COIL 392-0410Recalls & reported problems
Kaneka Corporation · The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04540778177048), received between Jun 12, 2023 and Jun 12, 2023 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Paralysis1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ANEURYSM LOCATED IN THE ANTERIOR CEREBRAL ARTERY (A2) UNDER MRI; COILS TREATMENT. 2 COIL CIRCLES PULL OUT OF THE ANEURYSM DURING THE RETURN MICROCATHETER PROCESS RESULTING IN THROMBOSIS IN THESE COIL CIRCLES IN THE VESSEL. ANTERIOR CEREBRAL ARTERY OCCLUSION LEADS TO HEMIPLEGIA.THE COILS WERE NOT STABLE INTO THE ANEURYSM DURING THE COILING PROCESS. THEREFORE, THE COILS WERE SUCKED OUT BY THE SUCTION OF THE MICROCATHETER WHEN THE MICROCATHETER WAS PULLED OUT.ON JUNE 1, 2023 ADDITIONAL INFORMATION: NOW THE PATIENT HAS REGAINED CONSCIOUSNESS.
Patient problems: Paralysis; Thrombosis/Thrombus
MAUDE report 17102941 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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