Axium Detachable Coil System QC-5-15-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037410), received between Jun 3, 2022 and Nov 7, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7, 2023Therapy Delivered to Incorrect Body Area; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Therapy Delivered to Incorrect Body Area; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION NEEDED TO TREAT THE PREMATURELY DETACHED COIL. IT WAS NOTED THAT THE PATIENT'S RIGHT LIMB IS SLIGHTLY LIMITED, AND THE DEGREE DECREASES WITH TIME. IT'S NOT CLEAR WHETHER IT IS LONG-TERM OR SHORT-TERM.

  Patient problems: Foreign Body In Patient; Paresis

  MAUDE report 18083140 ↗
• MalfunctionJun 3, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT AN AXIUM COIL BROKE OR DETACHED PREMATURELY DURING DELIVERY. THE COIL WAS REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER OR ATTEMPT TO REPOSITION THE COIL. NO ATTEMPT HAD BEEN MADE TO DETACH THE COIL.  THE PUSHWIRE WAS NOT BENT OR BROKEN AND THE PUSHWIRE WAS DISCARDED. IT WAS NOTED THE COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5.4MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICE: ECHELON 10 MICROCATHETER (MODEL: 105-5091-150, LOT: B323576).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14594478 ↗

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