Axium Detachable Coil System QC-4-10-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536037397), received between Jul 9, 2025 and Jul 9, 2025 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT OF A SACCULAR, UNRUPTURED LEFT POSTERIOR COMMUNICATING ARTERY SEGMENT OF INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 6.3MM AND A 4.2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT WHEN THE SURGEON WAS PERFORMING COIL FILLING OF THE ANEURYSM, THE SURGEON FOUND THAT THE AXIUM COIL DID NOT MOVE UNDER FLUOROSCOPY AND SUSPECTED THAT IT WAS ACCIDENTALLY DETACHED. AFTER WITHDRAWING IT FROM THE BODY TOGETHER WITH THE MICROCATHETER, THE SURGEON FOUND THAT THE COIL WAS STRETCHED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460404 ↗

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