Axium QC-10-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836462010468), received between Oct 13, 2021 and Oct 13, 2021 — classified as 1 malfunction.

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

• MalfunctionOct 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED IN THE MICROCATHETER DURING ITS RETRIEVAL AT THE FIRST TIME APPLICATION. THE COIL WAS REMOVED WITH THE CATHETER, AND NO ADDITIONAL SURGICAL/MEDICAL INTERVENTION WAS NEEDED. THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE HAD BEEN NO FRICTION/DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, AND NO DETACHMENT ATTEMPTS WERE MADE. A CONTINUOUS FLUSH WAS ADMINISTERED. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN INDIRECT CAROTID CAVERNOUS FISTULA THROUGH THE VENOUS APPROACH REACHING THE INFERIOR PETROSAL SINUS. ANCILLARY DEVICES INCLUDE A GUIDER GUIDE CATHETER, ECHELON 10 MICROCATHETER, TRANSEND .014 GUIDEWIRE, AND SYNCHRO 14 WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624471 ↗

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