AxiumTM QC-2-8-HELIX (UDI 00847536017474)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536017474), received between Apr 9, 2019 and Sep 13, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation 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 16, 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.

• MalfunctionSep 13, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE COILS COULD NOT BE PUSHED INTO THE MICROCATHETER. THE PATIENT WAS UNDERGOING COILING TREATMENT FOR A CORONARY VASCULAR OCCLUSION. IT WAS REPORTED THAT THE COIL WAS PUSHED INTO THE MICROCATHETER, AND IT WAS DIFFICULT TO PUSH WHEN IT ALMOST REACHED TO THE DISTAL END. AFTER THE RECYCLE, IT WAS FOUND THAT PUSH ROD OF THE COIL IN THE DISTAL SEGMENT WAS DAMAGED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE PATIENT¿S BLOOD FLOW WAS NORMAL. THE VESSEL WAS NORMAL TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT INJURY WAS REPORTED. YES, THE CONTINUOUS FLUSH ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN DID ROTATE THE DELIVERY PUSHERS DURING PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9029842 ↗
• MalfunctionApr 9, 2019Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT, AFTER DETACHMENT, THE MICROCATHETER WAS REMOVED BUT THE COIL MIGRATED AND WENT PARTLY OUT OF THE ANEURYSM. IT WAS NOTED THAT THE CAUSE OF THE ISSUE WAS DETACHMENT. THE PATIENT WAS UNDERGOING SURGERY FOR A SACCULAR, UNRUPTURED PCOM ANEURYSM WITH A MAX DIAMETER OF 5.5MM AND A NECK DIAMETER OF 4.5MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8498148 ↗

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