Axium Prime Detachable Coil System APB-6-10-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536038288), received between Jun 1, 2026 and Jun 1, 2026 — 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.

• MalfunctionJun 1, 2026Stretched; Material Deformation

  MEDTRONIC RECEIVED A REPORT OF 2 AXIUM COILS THAT WERE STRETCHED AND HAD A KNOT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, ANTERIOR COMMUNICATION ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.2 MM AND A 3.9 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT COILS WERE FOUND DEFECTIVE WHILE PERFORMING A COILING CASE. THE COILS GOT STRETCHED AND HAD A KNOT. THERE WAS NO FICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THERE WAS CONTINUOUS FLUSH ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED REPORTED THAT KNOT REFERS TO THE COILS BEING STRETCHED. LESION CHARACTERISTIC WAS SAID TO BE THE ANTERIOR COMMUNICATING ARTERY (ACOM).THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO OBSERVED DAMAGES ON THE DEVICE AND ALL INFORMATION HAS BEEN CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354429 ↗

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