Axium QC-6-20-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462010161), received between Feb 15, 2019 and Sep 16, 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 18, 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 16, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE IMPLANT COIL WAS FOUND TO BE STRETCHED AS IT WAS PUSHED OUT OF THE INTRODUCER SHEATH. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 10.8MM X 4.9MM LOCATED IN THE CAVERNOUS SINUS SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE VASCULATURE WAS MINIMAL IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL. THERE ARE NO IMAGES FOR REVIEW. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THERE WAS FRICTION WHEN PUSHING THE COIL OUT OF THE SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9069965 ↗
• MalfunctionFeb 15, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE BARE AXIUM COIL WAS SUCCESSFULLY IMPLANTED, HOWEVER, THE COIL FAILED TO DETACH WITH THE INSTANT DETACHER (ID). THE DETACHMENT ATTEMPT WAS ATTEMPTED 3 TIMES WITH THE ID. IT IS UNKNOWN IF MANUAL DETACHMENT WAS ATTEMPTED. A SECOND ID WAS NOT USED. THERE WERE ISSUES WITH THE ID. THERE WAS NO PATIENT INJURY. THE BLOOD FLOW AND THE ANATOMY WERE BOTH NORMAL. THE ANEURYSM WAS IN THE INTERNAL CAROTID. IT WAS UNRUPTURED AND SACCULAR, WITH A MAX DIAMETER OF 6 MM AND A NECK OF 3MM. THE DEVICES WERE REPORTED TO HAVE BEEN PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS STATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344584 ↗

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