Axium Detachable Coil System QC-16-40-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037571), received between Aug 28, 2024 and Nov 11, 2025 — 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.

• MalfunctionNov 11, 2025Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AXIUM COIL THAT HAD DETACHMENT ISSUES. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE AXIUM COIL DID NOT DETACH DESPITE 3 OR 4 ATTEMPTS TO DETACH WITH THE INSTANT DETACHER (ID). ANOTHER ID WAS NOT TRIED BUT THE PHYSICIAN ATTEMPTS TO DETACH THE COIL MANUALLY ANOTHER 3 TIES WITH THE HYPOTUBE BUT THE COIL STILL DID NOT FULLY DETACH, ONLY PARTIALLY. IT WAS REALIZED THE THE COIL FINALLY DETACHED ON ITS OWN WHEN THE NEXT COIL WAS BEING DEPLOYED, THUS THE COIL WAS IMPLANTED. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523890 ↗
• MalfunctionAug 28, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THE INSTANT DETACHER LOT NUMBER WAS B676425 VALIDITY PERIOD: 2027-1-7. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO¿PUSHWIRE¿DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT; THE COIL WAS NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20092112 ↗

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-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
• 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