Axium Detachable Coil System QC-4-6-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536037755), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 injury.

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.

• InjuryAug 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED TWO COILS WERE INSERTED AT THE SAME TIME. ONE OF THEM REQUIRED REPOSITIONING, DURING WHICH THE SPONTANEOUS DETACHMENT OCCURRED. IT WAS THOUGHT THAT THE SPONTANEOUS DETACHMENT MAY HAVE BEEN CAUSED BY THE REPOSITIONING. THE DETACHED COIL COULD NOT BE REMOVED FROM THE ARTERY DESPITE ATTEMPTS BY THE DOCTOR DURING THE PROCEDURE. THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION. THE PROCEDURE WAS COMPLETED BY EMBOLIZING THE ANEURYSM WITH OTHER COILS. THE PATIENT RECOVERED FROM THE PROCEDURE WITHOUT SYMPTOMS OR PECULIARITIES. NO DETACHMENT ATTEMPTS HAD BEEN MADE, AND THE PHYSICIAN DID NOT ROTATE THE DELIVERY WIRE DURING THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANEURYSM LOCATED IN THE ANTERIOR CEREBRAL ARTERY - ANTERIOR COMMUNICATING ARTERY (ACA-ACOM). THE PATIENT 'S VESSEL TORTUOSITY WAS SEVERE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494680 ↗

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