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AxiumTM QC-1.5-2-HELIX (UDI 00847536017177)Recalls & reported problems

Micro Therapeutics, Inc. · QC-1.5-2-HELIX BARE AXIUM 1.5MM X 2CM · 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 00847536017177), received between Mar 18, 2019 and Mar 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (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

  • Separation Failure1

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.

  • MalfunctionMar 18, 2019Separation Failure; Separation Failure

    MEDTRONIC RECEIVED INFORMATION THAT THIS COIL WOULD NOT ABLE TO DETACH WITH USING INSTANT DETACHER OR WITH MANUAL METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE). THE PATIENT WAS UNDERGOING COILING TREATMENT FOR AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN POSTERIOR COMMUNICATING ARTERY, MEASURING 2MMX8MM. THE VESSEL WAS MINIMAL TORTUOUS. THE BLOOD FLOW WAS NORMAL. PRIOR TO THE EVENT, THE MICROCATHETER REACHED TO THE LESION, AND THE FIRST SELECTED QC-1.5-2-HELIX COIL WITH ECHELON MICROCATHETER AND DELIVER THE COIL INTO THE TUMOR AND SUCCESSFULLY RELEASED. THE REPORTED COIL WAS SECOND COIL IN THE PROCEDURE, WHEN TRIED TO DETACH THE COIL, THE DID NOT DETACH WITH INSTANT DETACHER AFTER REPEATED ATTEMPT. THE PHYSICIAN ATTEMPTED TWO TIMES WITH MANUAL METHOD STILL COIL DID NOT DETACH. THE THIRD THE SPRING COIL QC-2-2-HELIX WAS REPLACED, AND IT CAN BE OPENED AND RELEASED SMOOTHLY. THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT'S CONDITION WAS STABLE AFTER SURGERY AND THE ANEURYSM DID NOT RUPTURE. REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8430761 ↗

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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