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AxiumTM QC-3-4-HELIXRecalls & reported problems

Micro Therapeutics, Inc. · QC-3-4-HELIX BARE AXIUM 3MM X 4CM · 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 00847536017559), received between Jun 2, 2022 and Jun 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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

  • Physical Resistance/Sticking1

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 2, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    MEDTRONIC RECEIVED A REPORT THAT THREE AXIUM COILS EXPERIENCED GREAT RESISTANCE IN THE MIDDLE SECTION OF THE ECHELON MICROCATHETER. SEVERAL ATTEMPTS WERE MADE TO DELIVER THE COIL, BUT THEY WERE UNSUCCESSFUL. IT WAS REPORTED TWO OF THE COILS WERE DAMAGED. A REPLACEMENT PRODUCT WAS USED IN THE COIL'S PLACE. IT WAS INDICATED THAT ALL DEVICES WERE PREPAREDAS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT CLINOID SEGMENT WITH A MAX DIAMETER OF 6.4 MM AND A 3.3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED COIL QC-2-3-HELIX LOT #: A624586 WAS NOT INVOLVED IN THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14574748 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

  • Z-0873-2012 · Mar 1, 2010 · Terminated
    Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab
  • Z-0874-2012 · Mar 1, 2010 · Terminated
    Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a

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Sources and updates

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