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i-ED COIL 390-0204Recalls & 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 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04540778176515), received between Sep 15, 2023 and Sep 15, 2023 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Aneurysm1
  • Ruptured Aneurysm1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    1ST COIL IN THE ICA WAS IMPLANTED AND DURING THE DEPLOYMENT OF THE LAST 1CM OF THE 2X4 SS, THE ANEURYSM RUPTURED. NOTED A NEW CATHETER(HEADWAY (17) WAS USED BEFORE THE COIL WAS DEPLOYED AND NO MENTION FROM THE MD THAT THE COIL WAS AT FAULT. THE SAME 2X4 SS WAS IMPLANTED THREE TIMES PRIOR WITH NO INCIDENT WITH A 156 HEADWAY DUO. EACH OF THE THREE 1ST ATTEMPTS THE LAST PORTION OF THE COIL KICKED OUT THE 156 HEADWAY DUO OUT OF THE ANEURYSM. THE RUPTURE OCCURRED WITH THE 4TH ATTEMPT WITH THE SAME 2X4 SS AND THE 1ST TIME USING THE HEADWAY 17 CATHETER. ONE ADDITIONAL COIL WAS PLACED, AND THE ANEURYSM WAS OCCLUDED. PATIENT WAS STABLE AFTER ANOTHER COIL WAS GIVEN AND COILING WAS COMPLETE. MANUFACTURER REPORT # 3009761573-2023-00003.

    Patient problems: Aneurysm

    MAUDE report 17754331 ↗
  • InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    1ST COIL IN THE ICA WAS IMPLANTED AND DURING THE DEPLOYMENT OF THE LAST 1CM OF THE 2X4 SS, THE ANEURYSM RUPTURED. NOTED A NEW CATHETER(HEADWAY 17) WAS USED BEFORE THE COIL WAS DEPLOYED AND NO MENTION FROM THE MD THAT THE COIL WAS AT FAULT. THE SAME 2X4 SS WAS IMPLANTED THREE TIMES PRIOR WITH NO INCIDENT WITH A 156 HEADWAY DUO. EACH OF THE THREE 1ST ATTEMPTS THE LAST PORTION OF THE COIL KICKED OUT THE 156 HEADWAY DUO OUT OF THE ANEURYSM. THE RUPTURE OCCURRED WITH THE 4TH ATTEMPT WITH THE SAME 2X4 SS AND THE 1ST TIME USING THE HEADWAY 17 CATHETER. ONE ADDITIONAL COIL WAS PLACED, AND THE ANEURYSM WAS OCCLUDED. PATIENT WAS STABLE AFTER ANOTHER COIL WAS GIVEN AND COILING WAS COMPLETE.

    Patient problems: Ruptured Aneurysm

    MAUDE report 17752991 ↗

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Sources and updates

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