Axium Detachable Coil System QC-4-10-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037779), received between Jul 11, 2022 and Mar 6, 2025 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMar 6, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS STUCK IN THE SHEATH AND ULTIMATELY DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT CAROTID ARTERY UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5.5MM AND THE NECK DIAMETER WAS 3MM. PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL EXPERIENCED RESISTANCE AND BECAME STUCK IN ITS SHEATH. THE COIL COULD NOT BE REMOVED EVEN AFTER FLUSHING AND WAS EVENTUALLY DETACHED INSIDE THE SHEATH. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537094 ↗
• InjuryJul 11, 2022Stretched; Separation Failure; Detachment of Device or Device Component; Stretched; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD ISSUES WITH NON-DETACHMENT AND THEN WAS STRETCHED AND IMPLANTED AT AN UNINTENDED LOCATION. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR RIGHT PERICALOSA ANEURYSM. THE ANEURYSM MEASURED 11.5 X 5.5MM WITH A NECK DIAMETER OF APPROXIMATELY 4MM WITH A FRONTOPOLARIS BRANCH. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NOTED TO BE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COMPLAINT COIL WAS THE SIXTH AND FINAL COIL TO BE IMPLANTED IN THE PROCEDURE. AFTER SUCCESSFUL PLACEMENT/POSITIONING OF THE COIL, A DETACHMENT ATTEMPT WAS MADE WITH THE INSTANT DETACHER (ID). THE DETACHER BROKE THE PUSHWIRE AS EXPECTED BUT THE COIL DID NOT DETACH. THE ID WAS THEN TRIED 4 TIMES WITHOUT SUCCESSFUL DETACHMENT. ANOTHER ID WAS NOT TRIED. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE ID. ONE ATTEMPT WAS THEN MADE AT MANUAL DETACHMENT AND THE PUSHWIRE SEPARATED WHERE THE ID HAD BROKEN THE PUSHWIRE. THE DETACHMENT WIRE WAS SEEN NORMALLY INSIDE BUT DESPITE PULLING IT, THE COIL WAS STILL ATTACHED TO THE PUSHW

  Patient problems: Foreign Body In Patient

  MAUDE report 14977800 ↗

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