AxiumTM PC-8-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536033375), received between Oct 25, 2022 and Oct 25, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionOct 25, 2022Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL EXPERIENCED RESISTANCE AND WAS STRETCHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE CAVERNOUS SINUS SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 7.5MM, AND THE NECK DIAMETER WAS 5.5MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE TIP OF THE COIL WAS DELIVERED INTO THE MICROCATHETER AND COULD NOT BE PUSHED FORWARD. IT WAS THEN RETRIEVED INTO THE PROTECTIVE SHEATH, AND IT WAS FOUND TO BE STRETCHED AFTER BEING PUSHED OUT FROM THE TIP. THE COIL WAS REPLACED, AND THE CATHETER WAS CONTINUED TO BE USED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE PROXIMAL PART OF THE CATHETER, AND THE COIL HAD PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE CATHETER MODEL WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670223 ↗

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