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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536029880), received between Apr 28, 2020 and Aug 11, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• MalfunctionAug 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED. NO DETACHMENT ATTEMPTS WERE MADE. THERE WAS NO RESISTANCE DURING DELIVERY OF THE COIL. THE COIL WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309058 ↗
• MalfunctionNov 20, 2020Separation Failure; Material Deformation; Separation Failure; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO PROBLEMS WERE ENCOUNTERED PRIOR TO THE NON-DETACHMENT. THE PUSHWIRE WAS OBSERVED TO BE BROKEN AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10877778 ↗
• InjuryOct 30, 2020Detachment of Device or Device Component; Material Deformation; Unintended Movement; Detachment of Device or Device Component; Material Deformation; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE DID NOT OBSERVE DAMAGE TO THE QC-3-6-3D COIL, BUT THE SURGEON STATED THAT IT WAS KINKED WHILE OPERATING. THERE HAD NOT BEEN ANY ADDITIONAL SURGERIES PERFORMED, THOUGH THE SURGEON SAID THAT IF THE PATIENT'S CONDITION WORSENS THE SPRING COIL MAY BE REMOVED. ONE COIL WAS IMPLANTED BEFORE THE COIL MALFUNCTION, AND 3 COILS WERE IMPLANTED AFTER.

  Patient problems: Foreign Body In Patient

  MAUDE report 10766482 ↗
• MalfunctionApr 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED NOTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. THE INTRODUCER SHEATH HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. BUT IT COULDN'T BE PUSHED OUT. IT WAS NOTED THAT THE COIL HAD BEEN EXTRUDED AND DEFORMED IN THE SHEATH. THERE WAS NO KINK/DAMAGE ON THE PUSHWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10007410 ↗

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