AxiumTM QC-5-15-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536030008), received between Mar 1, 2021 and May 13, 2022 — 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.

• MalfunctionMay 13, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM IN THE RIGHT CAVERNOUS SINUS SEGMENT. THE ANEURYSM MAX DIAMETER WAS 8MM AND THE NECK DIAMETER WAS 5MM. 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 COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY BUT HAD RESISTANCE AND COULD NOT BE ADVANCED THROUGH THE PROXIMAL END OF THE CATHETER. THE COIL WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. IT WAS NOTED THERE WAS NO DAMAGE TO THE COIL OR THE CATHETER. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER USED IN THE EVENT WAS AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402476 ↗
• MalfunctionOct 18, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE COIL PREMATURELY DETACHED IN VITRO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12648478 ↗
• MalfunctionMar 1, 2021Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT BROKE OR DETACHED PREMATURELY AND STRETCHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT POSTERIOR COMMUNICATING ARTERY. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 4MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES USED WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). DURING ANEURYSM FILLING IT WAS DISCOVERED THAT THE COIL COULD NO LONGER BE MANIPULATED AS THE COIL HAD BROKEN OR DETACHED PREMATURELY AND WAS STRETCHED. THERE WAS NO FRICTION OR OTHER ISSUE WITH DELIVERY PRIOR TO THE DETACHMENT. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ROTATE THE PUSHER. NO ATTEMPT HAD BEEN MADE AT DETACHMENT. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED. THE NEXT COIL WAS ABLE TO PUSH THE STRETCHED PORTION OF THE FIRST COIL INTO THE ANEURYSM SAC AND THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392359 ↗

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