AxiumTM QC-2-4-3D (UDI 00847536029811)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536029811), received between May 15, 2020 and Jul 15, 2022 — classified as 3 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 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.

• MalfunctionJul 15, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR RIGHT OPHTHALMIC ARTERY SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 4MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE SECOND COIL COULD NOT BE DETACHED SO IT WAS REMOVED. A COIL OF ANOTHER MODEL WAS THEN USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15028845 ↗
• MalfunctionJan 13, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE ONE AXIUM WAS FOUND TO BE STRETCHED AFTER BEING PUSHED OUT OF THE PROTECTIVE SHEATH AND ANOTHER COULD NOT BE PUSHED OUT OF THE PROTECTIVE SHEATH. IT WAS REPORTED THAT THE SPRING COIL WAS TAKEN OUT OF THE PACKAGE, PUSHED OUT OF THE PROTECTIVE SHEATH AND FOUND TO BE STRETCHED. ANOTHER COIL WAS OPENED BUT WAS UNABLE TO BE PUSHED OUT OF THE PROTECTIVE SHEATH. IT WAS REPLACED WITH ANOTHER SPRING COIL TO COMPLETE THE SURGERY. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE C6 SEGMENT OF THE LEFT INTERNAL CERVICAL ARTERY. THE MAX DIAMETER WAS 2 MM. THE NECK DIAMETER WAS 1.5 MM. THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11164800 ↗
• MalfunctionMay 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT RESISTANCE WAS ENCOUNTERED WHEN THE AXIUM COIL WAS ADVANCED THROUGH THE ECHELON CATHETER. THE COIL WAS ALLEGED TO HAVE UNINTENTIONALLY DETACHED IN THE CATHETER. THERE WAS ALSO REPORT OF ECHELON CATHETER MOVED OUT OF THE ANEURYSM. A 5F NAVIEN AND 6F SHEATH WERE SELECTED TO PROVIDE SUPPORT TO PASS THROUGH THE SEVERE TORTUOUS BLOOD VESSEL. AFTER THE ECHELON-10 45 ° MICROCATHETER WAS ADVANCED, THE FIRST AXIUM COIL CAUSED A TUBE TO KINK WHEN IT WAS PUSHING, CAUSING THE ECHELON MICROCATHETER TO EXIT THE TUMOR CAVITY. THE ECHELON WAS ADJUSTED TO RE-ADVANCE THE AXIUM COIL, BUT IT FAILED. THE COIL WAS REPORTED TO HAVE BEEN REPOSITIONED ONE TIME. THE COIL WAS NOT ATTEMPTED TO BE DETACHED. THE PUSHWIRE WAS NOT ROTATED. A CONTINUOUS FLUSH WAS USED. THE MICROCATHETER AND THE COIL WERE REMOVED, UPON ASSESSING THE REMOVED DEVICES, THE AXIUM COIL WAS FOUND TO HAVE INADVERTENTLY DETACHED IN THE MICROCATHETER. A REPLACEMENT QC-2-4-3D COIL WAS SUCCESSFULLY IMPLANTED AND COMPLETED THE SURGERY. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED SACCULAR, LEFT ANTERIOR COMMUNICATIN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10063399 ↗

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