Axium Detachable Coil System PC-16-40-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536044845), received between Mar 2, 2026 and May 26, 2026 — classified as 2 malfunctions.

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

• MalfunctionMay 26, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT DETACH AFTER USING THE DETACHER MORE THAN 3 TIMES. THEN, THE DOCTOR ATTEMPTED TO DETACHED WITH MANUAL DETACHMENT BUT THE COIL COULD NOT DETACH. THE DETACHING OF THE COIL WAS UNSUCCESSFUL. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT ARE UNKNOWN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A NEUROVASCULAR ABNORMALITIES (E.G. ARTERIOVENOUS MALFORMATIONS OR FISTULAE). IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS UNKNOWN AND VESSEL TORTUOSITY WAS UNKNOWN. ANCILLARY DEVICES INCLUDE A FG11150-0615-2X (BATCH 232300140) MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25277278 ↗
• MalfunctionMar 2, 2026Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THERE WERE NO CAUSES OR CONTRIBUTING FACTORS FOR THE NON-DETACHMENT. THERE WERE NO ISSUES ENCOUNTERED PRIOR NON-DETACHMENT. ALL THE INFORMATION HAS BEEN CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481876 ↗

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