Axium Detachable Coil System QC-3-4-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536037687), received between Apr 29, 2022 and Apr 20, 2026 — 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 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.

• MalfunctionApr 20, 2026Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED AND WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, RIGHT-SIDED C7 ANEURYSM WITH A MAX DIAMETER OF 4.8 MM AND A 3.6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING INTRACRANIAL ANEURYSM EMBOLIZATION, WHEN FILLING THE SECOND COIL, PREMATURE DETACHMENT OF THE COIL WAS OBSERVED UNDER IMAGING. THE COIL WAS REMOVED, REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS COMPLETED. THERE WAS REPORT THAT THE QC-3-4-3D WAS STRETCHED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE IMPLANT COIL WAS RETURNED FROM THE PATIENT. IT WAS REMOVED EXTRACORPOREALLY USING A GOOSENECK SNARE. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. TH PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927667 ↗
• MalfunctionMay 8, 2025Stretched; Stretched

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN UNRUPTURED ANEURYSM LOCATED AT THE RIGHT C4 WITH AMORPHOUS MORPHOLOGY USING A BARE AXIUM 3D COIL, THE QC COIL WAS STRETCHED BEFORE REACHING THE DETACHMENT MARK POINT. COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 4 MILLIMETERS AND A NECK DIAMETER OF 2 MILLIMETERS, WITH NORMAL BLOOD FLOW AND MODERATE VESSEL TORTUOSITY. THE PRODUCT WAS SUBSEQUENTLY EXPLANTED. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS REMOVED FROM THE PATIENT AND WILL BE RETURNED FOR EVALUATION. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO COIL SEPARATION, JUST COIL STRETCH. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THERE WERE NO DETACHMENT ATTEMPTS. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985925 ↗
• MalfunctionOct 13, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930839 ↗
• MalfunctionApr 29, 2022Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE IN THE CATHETER AND WAS DAMAGED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2.8MM. 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 MICROCATHETER WAS IN PLACE. HOWEVER, THE COIL COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. ANGIOGRAPHY SHOWED THE COIL DETACHED PREMATURELY. THE COIL WAS REMOVED AND WAS NOTED TO BE DAMAGED. THE CATHETER WAS NOT DAMAGED AND AFTER THE COIL WAS REPLACED, THE PROCEDURE WENT SMOOTHLY. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251476 ↗

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