Axium Detachable Coil System QC-10-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037946), received between May 23, 2025 and Jul 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Break; Separation Failure; Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM OF THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 14MM AND A 7MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SURGEON USED A AXIUM COIL TO EMBOLIZE THE ANEURYSM, BUT THE COIL COULD NOT BE DETACHED. THE SURGEON THEN REPLACED IT WITH ANOTHER COIL OF THE SAME MODEL, WHICH SUCCESSFULLY EMBOLIZED AND DETACHED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629998 ↗
• MalfunctionMay 23, 2025Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080224 ↗

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