Axium Detachable Coil System PC-3-8-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536044395), received between Nov 29, 2023 and Nov 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionNov 29, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO OBSERVED KINK OR DAMAGE OBSERVED ON PUSH WIRE. THERE WERE FIVE COILS (ALL AXIUM PRIME ES) DEPLOYED BEFORE RESISTANCE ISSUE WITH THE AXIUM PGLA COIL( DUE TO NON TAPERED COIL SHEATH). THERE WAS NO ISSUE WITH ECHELON 10 MICROCATHETER( BUT THE DOCTOR DID NOTE GAP BETWEEN ECHELON 10 HUB AND DISTAL END OF NON TAPERED COIL SHEATH OF AXIUM COIL. THE PATIENT WAS A 45 YEAR OLD WITH KNOWN LEFT INTRACRANIAL MASS WITH SIGNIFICANT VASCULAR SUPPLY FROM MULTIPLE ARTERIES IN NIR FOR EMBOLIZATION OF MULTIPLE SOURCES. DURING THE PROCEDURE A AXIUM COILS WAS SELECTED AND FOUND TO BE DEFECTIVE ONCE THE COIL WOULD NOT ADVANCE PAST THE SHEATH. AFTER MULTIPLE ATTEMPTS THE COIL WAS SAVED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233764 ↗

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