AxiumTM PC-2-6-3D (UDI 00847536033184)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536033184), received between Aug 10, 2022 and Aug 10, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 10, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE IN THE SHEATH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA. 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 COULD NOT BE ADVANCED OUT OF THE SHEATH INTO THE RHV/MICROCATHETER AND WAS STUCK. THE COIL WAS REMOVED AND TRIED IN VITRO ON THE TABLE BUT STILL COULD NOT BE PUSHED OUT OF THE INTRODUCER SHEATH. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICES: 6F SHEATH, 6F NEURON MAX 088 SHEATH, 5F SOPHIA GUIDE CATHETER, HEADWAY DUO MICROCATHETER ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS PREPARED LIKE DESCRIBED ABOVE (AS PER IFU). WHEN THE COIL WAS INSERTED INTO THE MICROCATHETER¿S RHV IT WOULD NOT ADVANCE IN THE INTRODUCER SHEATH AND WAS GETTING STUCK TO WHERE ONLY THE COIL COULD BE PUSHED OUT BUT IT WOULDN¿T ADVANCE ANY FURTHER. COIL WAS REMOVED AND THEY TRIED ADVANCING IT ON THE TABLE TO SEE WHAT THE ISSUE WAS AND SAME THING HAPPENED. LOOKED AS IF IT WAS GETTING STUCK AT THE PROXIMAL END OF THE INTRODUCER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201271 ↗

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