AxiumTM FC-5-10-3DRecalls & reported problems
Micro Therapeutics, Inc. · FRAMING COIL FC-5-10-3D V01 · Class 2 · Implant
All models of AxiumTM (139)
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 00847536022942), received between Apr 30, 2020 and Apr 30, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE RIGHT, ANTERIOR, CEREBRAL ARTERY WITH A MAX DIAMETER OF 5.1MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL WAS ADVANCED TO THE ANEURYSM, BUT IT WAS NOTICED NECK MAY BE TOO WIDE FOR TREATMENT. THE COIL WAS REPOSITIONED THREE TIMES ALL THE WAY TO THE DETACHMENT ZONE. AFTER THE THIRD TIME, THE PHYSICIAN WAS GOING TO REMOVE THE COIL, BUT WHEN THE PUSHER WAS PULLED UNDER FLUORO, THE COIL DID NOT MOVE. IT WAS REALIZED THE COIL DETACHED. TWO OR THREE LOOPS OF THE COIL WERE IN THE PARENT ARTERY, BUT IT STILL MAINTAINED NORMAL FLOW. THE PROCEDURE WAS COMPLETED BY COILING THE ANEURYSM WITH FOUR ADDITIONAL COILS AS THE FIRST COIL WAS IMPLANTED AT THE INTENDED LOCATION. THERE WAS NO DAMAGE NOTED TO THE PUSHWIRE, NO RESISTANCE, NO DETACHMENT ATTEMPTSMADE, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. NO HARM WAS REPORTED TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10013403 ↗
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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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