AxiumTM QC-4-12-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536029590), received between Apr 19, 2021 and Nov 12, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 27, 2022Class IIOpen, Classified

   Due to incorrect size and configuration labeling of the detachable coil system.

   Z-1261-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗

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 12, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THAT PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR RIGHT POSTERIOR COMMUNICATING ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5.24MM AND THE NECK DIAMETER WAS 2.1MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS DEPLOYED BUT COULD NOT BE DETACHED WITH THE INSTANT DETACHER (ID). 3 ATTEMPTS WERE MADE TO DETACH THE COIL WITH THE ID WITHOUT SUCCESS. 2 ATTEMPTS WERE THEN MADE AT MANUAL DETACHMENT WITH THE HYPOTUBE BUT THIS WAS ALSO UNSUCCESSFUL. THE COIL WAS REMOVED AND REPLACED WITH AN AXIUM 4X10 COIL THAT WAS DELIVERED AND DETACHED WITH THE SAME ID WITHOUT ISSUE. IT WAS NOTED THERE WAS NO PROBLEM WITH THE ID. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICES: CORDIS 6F SHEATH, CHAPERON 6F GUIDE CATHETER, EXCELSIOR SL-10 MICROCATHETER, SYNCHRO 14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805120 ↗
• MalfunctionApr 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED NO DETACHMENT ATTEMPTS WERE MADE, AND THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE. ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11688358 ↗

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