Axium™ Detachable Coil System QC-4-10-3DRecalls & reported problems
Micro Therapeutics, Inc. · COIL QC-4-10-3D V14 · Class 2 · Implant
All models of Axium Detachable Coil System (69)
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 00763000845872), received between Jun 30, 2026 and Jun 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Separation Failure1
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.
MalfunctionJun 30, 2026Separation Failure; Material Deformation
MEDTRONIC RECEIVED A REPORT THAT THERE WAS AXIUM COIL NON-DETACHMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED INTERNAL CAROTID ARTERY (ICA) BIFURCATION BRANCH ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 3.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DETACH BOTH COILS USING ID-1-5 INSTANT DETACHER MULTIPLE TIMES. COIL DID NOT DETACH. PHYSICIAN USED THE BACK UP METHOD AND BROKE THE WIRE AND PULLED THE SUTURE AND BOTH COILS STILL DID NOT DETACH. THE SUTURE STRETCHED IN BOTH CASES. THE PHYSICIAN THEN PULLED HARDER AND MORE AGGRESSIVELY AND THE COILS FINALLY RELEASED. THERE WAS COIL NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 TIMES AND AN ADDITIONAL 3 TIMES WITH A SECOND INSTANT DETACHER. THERE WERE TWO MANUAL ATTEMPTS AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. ANCILLARY DEVICES INCLUDE A BENCHMARK BMK6F105, SL10 M00316890, A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673369 ↗
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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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