i-ED COIL 393-030530Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04540778190429), received between Apr 24, 2025 and Apr 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2025Fracture; Fracture
35MMX 30CM COIL WAS PLACED IN THE POSTERIOR DIVISION OF THE LEFT MMA AFTER A 2X 12CM COIL WAS SUCCESSFULLY DEPLOYED. COIL WAS COMPLETELY OUT OF THE SL10 CATHETER, BUT MD WANTED THE COIL TO FLIP INTO THE FRONTAL DIVISION. THE COIL WAS TAKEN OUT AND PUT ON THE BACK TABLE. THE MD THEN RESELECTED THE FRONTAL DIVISION WITH A WIRE AND THE SAME SL10. THE SAME 35MMX30CM, WAS THEN PLACED INTO THE SMALLER FRONTAL DIVISION. THE COIL HAD A VERY HARD TIME FORMING ITS SHAPE IN THE SMALL VESSEL. THE MD NOTICED THAT HE WAS USING A LOT OF FORCE TO PUSH THE COIL OUT TO THE POINT THAT HE BENT THE WIRE OF THE COIL. SO THAT HE WAS SUGGESTED TO REMOVE THE COIL AND USE ANOTHER 2X12CM COIL. AS HE WAS REMOVING THE COIL, THE CATHETER MOVED INTO A FAVORABLE POSITION, SO ONE LAST ATTEMPT WAS TRIED WITH35MM X 30CM (3RD ATTEMPT). AT THAT POINT, THE COIL BROKE WITH EXCESSIVE FORCE AND NOT A LOT OF SUPPORT (BENCHMARK 71 AND SL10). A 2MM SNARE WAS USED TO REMOVE THE COIL THAT WAS LEFT IN THE VESSEL WITH NO COMPLICATIONS NOTICED TO THE PATIENT. NO FURTHER ACTION WAS NEEDED BUT SINCE THE COIL BROKE (STRETCHED) AND A SNARE (RETRIEVAL DEVICE) WAS USED A COMPLAINT WAS DOCUMENTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898653 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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