Axium Detachable Coil System QC-5-10-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037809), received between Sep 12, 2023 and Oct 22, 2024 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE PREMATURE DETACHMENT AND COIL STRETCH WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE CATHETER USED IN THE EVENT WAS AN SL-10. THIS COIL WAS THE FIRST COIL USED IN THE PROCEDURE, AND 4 COILS WERE SUBSEQUENTLY FILLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507042 ↗
• MalfunctionSep 12, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT IT BECAME IMPOSSIBLE  TO DETACH THE AXIUM COIL. THE PHYSICIAN USED 1 INSTANT DETACHER 2 TIMES AND WAS STILL UNSUCCESSFUL IN DETACHING THE AXIUM COIL. THE PHYSICIAN TRIED TO DETACH THE AXIUM COIL 2 TIMES WITH THE HYPOTUBE BUT WAS UNSUCCESSFUL. ANOTHER AXIUM COIL WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THE AXIUM COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT POSTERIOR COMMUNICATING (PCOM) ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5.68MM AND A 3.51MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL.  ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733763 ↗

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