AxiumTM QC-1.5-3-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536017184), received between Feb 11, 2019 and Feb 11, 2019 — 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 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.

• MalfunctionFeb 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT PASS AT THE PROXIMAL END OF THE MICROCATHETER DUE TO RESISTANCE. IT WAS NOTED THAT THE COIL PUSHED OUT FROM THE INTRODUCER SHEATH SMOOTHLY. THERE WAS REPORTEDLY NO DAMAGE TO THE COIL AND CATHETER OBSERVED. IT WAS STATED THE HYDRATION CHECK IN VITRO WAS NORMAL. AS A RESULT, THE COIL WAS REPLACED AND THE SURGERY WAS COMPLETED AS NORMAL. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 3MM AND A NECK DIAMETER OF 2MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. YES, THE CONTINUOUS FLUSHED WAS ADMINISTERED DURING THE PROCEDURE. AS THE OPERATION CONTINUED, THE REPLACEMENT OF THE SPRING COIL CAN BE NORMALLY DELIVERED INTO THE MICROCATHETER AND DISCARDED POSTOPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8330024 ↗

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