AxiumTM QC-2-6-HELIX (UDI 00847536017450)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536017450), received between Jul 27, 2020 and Nov 4, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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.

• MalfunctionNov 4, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE MIDDLE CEREBRAL ARTERY. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE COIL WAS DELIVERED WITH SOME FRICTION FELT. DURING THE PROCESS OF FILLING THE ANEURYSM, THE PHYSICIAN REALIZED THE COIL HAD ACCIDENTALLY DETACHED. THE MICROCATHETER AND COIL WERE WITHDRAWN TOGETHER. NO DAMAGE WAS OBSERVED TO THE PUSHWIRE. THE PHYSICIAN HAD NOT REPOSITIONED THE COIL, ROTATED THE PUSHER, OR ATTEMPTED TO DETACH THE COIL. CONTINUOUS CATHETER FLUSH WAS PROVIDED. THE COIL WAS REPLACED WITH ANOTHER OF THE SAME MODEL WITH THE SAME MICROCATHETER TO CONTINUE THE PROCEDURE. ALL DEVICES HAD BEEN PREPARED PER THE INSTRUCTIONS FOR USE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10788287 ↗
• MalfunctionJul 27, 2020Deformation Due to Compressive Stress; Detachment of Device or Device Component; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT FOR THE THIRD COIL THAT HAD RESISTANCE AND BECAME DETACHED (MODEL #: QC-2-6-HELIX, LOT #: A691561), NO ATTEMPTS WERE MADE TO DETACH THE COIL. THE COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING COILS THAT DID NOT HAVE RESISTANCE IN THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10326687 ↗

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