AxiumTM QC-6-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536030039), received between Jan 12, 2022 and Jan 24, 2023 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2023Stretched; Stretched

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS STRETCHED. THAT PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR RIGHT PARA CLINOID SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 5MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS ADVANCED IN THE MICROCATHETER BUT, DURING DEPLOYMENT, DID NOT TAKE THE EXPECTED DESIRED SHAPE. THE COIL WAS WITHDRAWN AND FOUND TO BE STRETCHED. IT WAS NOTED THAT THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY OF THE COIL. THE PHYSICIAN HAD TRIED TO REPOSITION THE COIL TWICE. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237223 ↗
• MalfunctionOct 13, 2022Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPRING COIL WAS PARTIALLY BROKE AND STRETCHED. THE COIL DID NOT PREMATURELY SEPARATE FROM THE DELIVERY WIRE. PART OF THE COIL WAS SEPARATED FROM THE REST. THERE WERE NO OTHER ISSUES. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE ENTIRE COIL WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597918 ↗
• MalfunctionJan 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5.9MM AND THE NECK DIAMETER WAS 4MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE AXIUM COIL (MODEL: QC-6-20-3D, LOT: B115267) WAS SELECTED TO FORM THE HOOP. THE COIL WAS ADJUSTED TWICE DURING THE PROCESS OF FORMING THE HOOP AND DURING AN ADJUSTMENT IT WAS OBSERVED THAT THE COIL HAD DETACHED FROM THE PUSHER. THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING THE DELIVERY PROCESS. THE PHYSICIAN DID NOT ROTATE THE PUSHER DURING THE PROCEDURE AND THERE WAS NO DAMAGE NOTED TO THE PUSHER. THERE WAS NO ATTEMPT MADE TO DETACH THE COIL. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL DETACHED IN THE MICROCATHETER SO THE DEVICES WERE REMOVED TOGETHER AND THE COIL WAS REPLACED WITH ANOTHER OF THE SAME MODEL AND THE OPERATION PROCEEDED WITHOUT ISSUE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICE:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237151 ↗

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