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AxiumTM QC-2-2-3DRecalls & reported problems

Micro Therapeutics, Inc. · COIL QC-2-2-3D V04 AXIUM · Class 2 · Implant

Data updated Oct 13, 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 00847536029804), received between Jul 18, 2022 and Jul 18, 2022 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Separation Failure1

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.

  • MalfunctionJul 18, 2022Separation Failure; Separation Failure

    MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE ECHELON 10 MICROCATHETER CRACKED DURING THE PROCESS OF FILLING THE COIL, A COIL EXPERIENCED RESISTANCE, AND ANOTHER COIL FAILED TO DETACH. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE C7 SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 6.2MM, AND THE NECK DIAMETER WAS 5.1MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 8.1MM IN DIAMETER. IT WAS REPORTED THAT THE ECHELON COIL RUPTURED DISTALLY BUT WAS INTACT. THERE WAS WAS NO FRICTION/DIFFICULTY DURING DELIVERY, AND THERE WAS NO OTHER DAMAGE TO THE CATHETER. THE INJECTION RATE WAS SAID TO BE 100PSI. THERE WAS RESISTANCE WHEN THE SPRING COIL ENTERED THE DISTAL END OF THE ECHELON MICROCATHETER, AND IT COULD NOT BE PUSHED. THERE WAS NO DAMAGE TO THE COIL OR CATHETER. ANOTHER COIL IN THE PROCEDURE COULD NOT BE DETACHED. TWO ATTEMPTS EACH WERE MADE WITH THE INSTANT DETACHER AND THE MANUAL METHOD. A SECOND INSTANT DETACHER WAS NOT USED. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. THE DEVICES WERE REPLACED, AND THE PATIENT DID NOT EXPERIENCE AN

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15048410 ↗

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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