Axium Detachable Coil System QC-2.5-8-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536037670), received between May 8, 2023 and May 8, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionMay 8, 2023Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT REGARDING AXIUM COIL RESISTANCE AND ECHELON CATHETER RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4.5  MM AND A 3.3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN THE AXIUM COIL WAS PUSHING IN THE ECHELON, THE PUSHING GUIDE ROD GOT STUCK AND COULD NOT BE PUSHED FORWARD OR RETRIEVE, SO THE COIL AND MICROCATHETER WERE REMOVED. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE DISTAL SECTION OF THE CATHETER. IT IS UNKNOWN IF THERE WAS CATHETER DAMAGE. THERE WAS COIL DAMAGE PRESENT ON THE PUSHWIRE DISTAL SEGMENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A NEUROMAX SHEATH, NAVIEN 6F GUIDE CATHETER, ECHELON MICROCATHETER, SYNCHRO 2 GUIDEWIRE, AND ENTERPRISE 4.5X22. ADDITIONAL INFORMATION RECEIVED REPORTED THE COILS DID NOT PUSH OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887760 ↗

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