Axium QC-10-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00836462010475), received between Apr 2, 2019 and Mar 1, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2024Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE STRETCH WAS NOT DETERMINED. DUE TO NORMAL PROCESS OPERATION, IT WAS SUSPECTED THAT THERE WAS A QUALITY CONTROL ISSUE WITH THE SPRING COIL. THE AXIUM COIL DETACHED ON IT'S OWN. THERE WERE NOT ANY ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE COIL WAS IMPLANTED. A TOTAL OF 36 COILS WERE IMPLANTED BEFORE AND AFTER THIS COIL MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816390 ↗
• MalfunctionSep 29, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT POOR DETACHMENT OCCURRED. THE COIL COULD NOT BE DETACHED SO IT WAS REMOVED. IT WAS UNKNOWN HOW MANY TIMES THE PHYSICIAN ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS ONE MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. IT WAS UNKNOWN IF THERE WAS ANY ISSUE WITH THE INSTANT DETACHER. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTION IN THE PACKAGE INSERT. ANCILLARY DEVICES INCLUDE A SHEATH, ROADMASTER/GOODMAN GUIDE CATHETER, SL10 MICROCATHETER, AND SYNCHRO GUIDEWIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844428 ↗
• MalfunctionSep 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY. NO PATIENT INFORMATION WAS REPORTED. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OF THE COIL. THE PHYSICIAN REPOSITIONED THE COIL TWICE AND IT DETACHED PREMATURELY. THE PHYSICIAN HAD NOT TRIED TO DETACH THE COIL. THE COIL WAS REMOVED WITH THE CATHETER AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE TO COMPLETE THE PROCEDURE. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. ANCILLARY DEVICES: ENVOY 6F GUIDE CATHETER, PHENOM 17 (MODEL: FG11150-0615-2X) MICROCATHETER, SYNCHRO 14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406975 ↗
• MalfunctionApr 2, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT OF AXIUM NON-DETACHMENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED 15 MM ANEURYSM. THE PATIENT¿S VASCULATURE WAS MINIMAL IN TORTUOSITY. IT WAS REPORTED THAT DURING THE PROCEDURE, THE AXIUM COIL COULD NOT BE DETACHED USING AN INSTANT DETACHER. ATTEMPT TO DETACH WAS ALSO MADE USING THE MANUAL METHOD (BREAKING OF THE HYPOTUBE, AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE) BUT WITHOUT SUCCESS. THE IMPLANT COIL WAS PULLED BACK INTO THE MICROCATHETER AND REMOVED FROM THE PATIENT. ANOTHER AXIUM COIL OF THE SAME SIZE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY AS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8476447 ↗

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