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AxiumTM QC-5-10-3DRecalls & reported problems

Micro Therapeutics, Inc. · COIL QC-5-10-3D V04 AXIUM · 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 00847536029996), received between Jan 4, 2021 and Jan 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Material Deformation1

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.

  • MalfunctionJan 4, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

    MEDTRONIC RECEIVED A REPORT THAT THERE WAS A BREAK BETWEEN THE COIL AND THE PUSH ROD, AND THE PUSHER WAS KINKED/BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE IMPLANT COIL WAS DAMAGED, AND THE DEVICE WAS REPLACED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 8.45 MM, AND THE NECK DIAMETER WAS 4.2 MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MINIMAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11113505 ↗

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-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
  • 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

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Sources and updates

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