Axium Detachable Coil System QC-3-4-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037359), received between Aug 24, 2023 and Jul 11, 2024 — 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.

• MalfunctionJul 11, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE OPERATION PROCEEDED NORMALLY AFTER REPLACING WITH THE OTHER COIL. THE CAUSE OF THE DETA CHMENT ISSUE WAS UNKNOWN. 4 ATTEMPTS WERE MADE TO DETACH THE COIL USING THE INSTANT DETACHER. 2 ATTEMPTS WERE MADE TO DETACH THE COIL USING THE MANUAL METHOD. THE DETACHER HAD BEEN STERILIZED BY THE HOSPITAL. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720673 ↗
• MalfunctionAug 24, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED NO DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER. THE MANUAL DETACHMENT METHOD WAS USED (B)(4) TIMES. PRIOR TO COIL NON-DETACHMENT NO ISSUES WERE ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17613692 ↗

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