AxiumTM QC-5-15-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536029606), received between Aug 23, 2022 and Aug 23, 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 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.

• MalfunctionAug 23, 2022Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE IN THE ECHELON 10 MICROCATHETER AND WAS STRETCHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR LEFT POSTERIOR COMMUNICATION ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 8MM AND THE NECK DIAMETER WAS 4.5MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS IN PLACED AND THE COIL WAS HYDRATED. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS PUSHED INTO THE MICROCATHETER AND THERE WAS OBVIOUS RESISTANCE. AFTER FLUSHING, THE COIL STILL HAD RESISTANCE. THE COIL WAS THEN RECOVERED AND FOUND TO HAVE WIRE DRAWING AND STRETCHING. IT WAS NOTED THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICES: 6F SHORT SHEATH, 8F GUIDE CATHETER, SYNTHRO GUIDEWIRE ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY BUT HAD RESISTANCE IN THE PROXIMAL END OF THE ECHELON 10 MICROCA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276499 ↗

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