Axium Detachable Coil System QC-14-40-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037984), received between Oct 24, 2022 and Apr 1, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Stretched; Packaging Problem; Stretched; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS STRETCHED PRIOR TO USE IN THE PATIENT'S BODY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT C4 SEGMENT GIANT LATERAL UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 13MM AND THE NECK DIAMETER WAS 9MM. PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE INITIAL UNPACKING OF A THE AXIUM COIL, IT WAS FOUND STRETCHED AT THE COIL BODY AND CONNECTING ROD OUTSIDE THE PATIENT'S BODY. IT WAS NOTED THAT THE COIL AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE STRETCHED COIL WAS REPLACED WITH ANOTHER MODEL, AND THE SURGERY PROCEEDED SUCCESSFULLY. AS THE ISSUE WAS OBSERVED DURING UNPACKING AND OUTSIDE THE PATIENT'S BODY, IT IS CONSIDERED THAT THERE IS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. THE CAUSE OF THE DAMAGE WAS UNKNOWN. NO PREP WAS PERFORMED PRIOR TO THE DAMAGE BEING SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749128 ↗
• MalfunctionOct 24, 2022Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT RESISTANCE OCCURRED IN THE DISTAL SECTION OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL OR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659165 ↗

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