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AxiumTM PC-4-8-HELIXRecalls & reported problems

Micro Therapeutics, Inc. · COIL PC-4-8-HELIX V04 · Class 2 · Implant

All models of AxiumTM (139)

Data updated Oct 16, 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 00847536033023), received between Mar 30, 2020 and Mar 30, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

  • Break1
  • Physical Resistance/Sticking1

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 30, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

    MEDTRONIC RECEIVED A REPORT THAT THREE AXIUM COILS EXPERIENCED RESISTANCE DURING DELIVERY, AND ONE BROKE UPON RETRIEVAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A CCF NEUROVASCULAR ABNORMALITY. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE REBAR MICROCATHETER WAS PLACED, AND THE FIRST COIL WAS DEPLOYED WITH NO ISSUE. WHEN DELIVERING THE SECOND COIL (PLI10), THERE WAS A STRONG RESISTANCE FELT, BUT IT WAS DEPLOYED SUCCESSFULLY. THE THIRD COIL (PLI20) EXPERIENCED STRONGER RESISTANCE AND COULD NOT BE DEPLOYED. DURING RETRIEVAL THE COIL BROKE INTO TWO PIECES; ONE PIECE WAS INSIDE THE ANEURYSM AT THE INTENDED LOCATION, THE OTHER PIECE WAS RETRIEVED SUCCESSFULLY, AND THE PUSHWIRE WAS BENT/BROKEN UPON INSPECTION. THE REPLACEMENT COIL DEPLOYED EASILY AND IN TOTAL, SIX COILS WERE USED TO FILL THE ANEURYSM. A SEVENTH COIL (PLI30) WAS TO BE ADDED, BUT RESISTANCE WAS FELT AGAIN DURING THE DELIVERY. THE FLOW WAS CHECKED WITHOUT THE COIL, AND IT WAS DETERMINED THE LAST COIL WAS NOT NEEDED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM INDICATED IN THE EVENT. ANCILLARY DEVICES INCLUDE A REBAR 18 MICROCATHETER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9898301 ↗

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

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