i-ED COIL 393-030520Recalls & 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
- 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 04540778177321), received between Nov 6, 2025 and Nov 10, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Ruptured Aneurysm2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR WAS ON THE THIRD I-ED COIL (FIRST TWO WERE FRAMING COILS) FOR THE CASE AND THEN FELT SOMETHING GIVE PRESSURE BACK AND THEN TOOK A PICTURE AND CONFIRMED THAT WE HAD RUPTURED THE ANEURYSM. DOCTOR THEN ASKED TO REVERSE PROTAMINE AND THEN CALLED FOR A 4X20 SCEPTER BALLOON AND 5X20CM AXIUM COIL TO STOP BLEEDING. PATIENTS BLOOD PRESSURE STARTED FALLING UNTIL BALLOON WAS INSERTED. THEN PATIENT WAS STABILIZED AND WAS TAKEN TO NEURO ICU. MFR REPORT #3009761573-2025-00003.
Patient problems: Ruptured Aneurysm
MAUDE report 23511938 ↗InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR WAS ON THE THIRD I-ED COIL (FIRST TWO WERE FRAMING COILS) FOR THE CASE AND THEN FELT SOMETHING GIVE PRESSURE BACK AND THEN TOOK A PICTURE AND CONFIRMED THAT WE HAD RUPTURED THE ANEURYSM. DOCTOR THEN ASKED TO REVERSE PROTAMINE AND THEN CALLED FOR A 4X20 SCEPTER BALLOON AND 5X20CM AXIUM COIL TO STOP BLEEDING. PATIENTS BLOOD PRESSURE STARTED FALLING UNTIL BALLOON WAS INSERTED. THEN PATIENT WAS STABILIZED AND WAS TAKEN TO NEURO ICU.
Patient problems: Ruptured Aneurysm
MAUDE report 23493816 ↗
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- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
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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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