Axium Detachable Coil System QC-3-8-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536037373), received between Feb 7, 2023 and Nov 7, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2024Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL COULDN'T BE DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE SURGEON USED THE COIL TO EMBOLIZE A POSTERIOR COMMUNICATING ARTERY ANEURYSM. WHEN THE COIL WAS DETACHED BY THE BACKUP DETACHMENT METHOD, THE DETACHMENT WIRE HAD BEEN COMPLETELY BROKEN OUT, BUT THE COIL WAS NOT DETACHED. SO THE WHOLE WAS COMPLETELY WITHDRAWN FROM THE MICROCATHETER, AND IT AUTOMATICALLY FELL OFF OUTSIDE THE MICROCATHETER AFTER WITHDRAWN. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER. THERE WAS 1 MANUAL ATTEMPT AT DETACHMENT. 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 20630727 ↗
• MalfunctionMay 22, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369912 ↗
• MalfunctionNov 10, 2023Break; Inadequacy of Device Shape and/or Size; Stretched; Break; Inadequacy of Device Shape and/or Size; Stretched

  ADDITIONAL INFORMATION WAS RECEIVED THAT ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND WAS DURING THE OPERATION, IT WAS TRIED TO RETRACT THE COIL BODY AND FOUND THAT THE DISTAL END WAS UNCONTROLLABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18113119 ↗
• MalfunctionFeb 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  NEW INFORMATION WAS RECEIVED. THE FIELD CONTACT INITIALLY REPORTED THE EVENT TO MEDTRONIC. THE TREATING PHYSICIAN¿S NAME AND CONTACT INFORMATION (PHONE NUMBER) IS ZHOU CHUANKAI. CONTACT INFORMATION THE QC-14-40-3D DETACHABLE SPRING COIL WAS DETACHED WHEN IT WAS TAKEN OUT OF THE PROTECTIVE SHEATH. THE OPERATOR BELIEVED THAT THIS WAS A PRODUCT QUALITY PROBLEM AND REQUESTED TO RETURN IT. PLEASE IDENTIFY IT. THE COIL PREMATURELY SEPARATED FROM THE DELIVERY WIRE. PART OF THE COIL DID NOT FRACTURE AND SEPARATE FROM THE REST. THE CATHETER MODEL AND LOT NUMBER ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310923 ↗

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