Skip to content

AxiumTM QC-3-8-HELIX (UDI 00847536017634)Recalls & reported problems

Micro Therapeutics, Inc. · BARE AXIUM QC-3-8-HELIX · 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 00847536017634), received between Aug 21, 2019 and Aug 21, 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.

  • MalfunctionAug 21, 2019Separation Failure; Separation Failure

    MEDTRONIC RECEIVED INFORMATION THAT THIS COIL WOULD NOT DETACH WITH AN INSTANT DETACHER OR USING MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE). THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A SMALL UNRUPTURED SACCULAR LEFT CLINOID ANEURYSM, MEASURING 4MMX5.1MM IT WAS REPORTED THAT THE MICROCATHETER WAS PLACED IN PLACE TO DELIVER THE COIL. AFTER DELIVERY, IT WAS RELEASED. THE REPLACEMENT OF THE DETACHER FAILED TO BE RELEASED. REPLACED OTHER PRODUCTS. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DETACH THE COIL TWO TIMES WITH THE INSTANT DETACHER AND ONE TIME WITH SECOND DETACHER, BUT THIS COIL DID NOT DETACH. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. NO PATIENT INJURY WAS REPORTED. THE PATIENT¿S BLOOD FLOW WAS NORMAL. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. AS A RESULT OF THE ISSUE THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. A MANUAL DETACHMENT METHOD WAS ATTEMPTED, THE COIL WAS REMOVED FROM THE PATIENT. ECHELON 10, INSTANT DETACHER WAS DISCARD

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8916341 ↗

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

Other Device, Vascular, for Promoting Embolization devices

All Device, Vascular, for Promoting Embolization devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page