AxiumTM QC-2-4-3D (UDI 00847536017399)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536017399), received between Dec 14, 2018 and Sep 20, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE MICROCATHETER AND INTRACRANIAL SUPPORT CATHETER WERE IN PLACE, A QC-3-6-3D WAS FILLED FIR ST. THEM IT WAS FOUND A QC-2-4-3D COULD NOT ENTER THE MICROCATHETER DUE TO RESISTANCE IN THE SHEATH. A REPLACEMENT COIL OF THE SAME MODEL WAS USED, AND IT PASSED SMOOTHLY. THE PROCEDURE WAS THEN COMPLETED WITH NO FURTHER ISSUE REPORTED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING PREPARATION, 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 12502470 ↗
• MalfunctionNov 22, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL BECAME STUCK IN THE MICROCATHETER THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 7.23 MM AND A 5.17 MM NECK DIAMETER.IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT WHEN THE SPRING COIL WAS TRANSPORTED OUT OF THE MICROCATHETER, IT COULDN'T BE SUCCESSFULLY PUSHED OUT AND GOT STUCK IN THE DISTAL PORTION OF THE MICROCATHETER. THERE WAS NO DAMAGE TO THE CATHETER, BUT THE DISTAL SEGMENT OF THE PUSHWIRE WAS DAMAGED. IT WAS INDICATED THAT ALL PRODUCTS WERE PREPARED AS PER INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9363151 ↗
• MalfunctionApr 9, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL BECAME STUCK IN THE HUB OF A MICROCATHETER. THE DEVICES WERE REPLACED WITH MEDTRONIC DEVICES TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE COILS WERE REPORTED TO HAVE BEEN PUSHED SMOOTHLY OUT OF THE INTRODUCER SHEATHS AND THE SHEATHS WERE SEATED SECURELY IN THE HUB OF THE MICROCATHETERS. THE COIL WAS RETURNED AND THE PUSHWIRE WAS OBSERVED TO BE SEPARATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8495219 ↗
• MalfunctionDec 14, 2018Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE COIL DID NOT SEPARATE FROM THE PUSHWIRE. A CONTINUOUS FLUSH WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8165525 ↗

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