Axium Detachable Coil System QC-2.5-4-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536037656), received between Sep 20, 2021 and Dec 11, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM OF THE ANTERIOR CEREBRAL COMMUNICATING ARTERY, THE BARE AXIUM 3D COIL SPRING COIL COULD NOT BE PUSHED OUT OF THE PROTECTIVE SLEEVE DURING DELIVERY. THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE ANEURYSM HAD A MAXIMUM DIAMETER OF 2.6 MILLIMETERS AND A NECK DIAMETER OF 1.8 MILLIMETERS, WITH NORMAL BLOOD FLOW AND VESSEL TORTUOSITY NOTED. THE PRODUCT WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT A CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. 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 23782265 ↗
• MalfunctionJun 3, 2024Break; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM SPRING COIL WAS STRETCHED DURING THE INSERTION OF THE Y-VALVE INTO THE MICROCATHETER. IT WAS REPORTED COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE IMPLANT COIL IS IN THE Y-VALVE OF THE MICROCATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN 8F SHEATH, 6F NAVIEN GUIDE CATHETER, ECHELON MICROCATHETER, SYNCHRO2 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447394 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE HAD BEEN NO DETACHMENT ATTEMPTS PRIOR TO THE COIL PREMATURE DETACHMENT. THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE. ONE COIL HAD BEEN IMPLANTED PRIOR TO THE COMPLAINT COIL. THE CAUSE OF THE PREMATURE DETACHMENT WAS UNKNOWN BUT IT WAS THOUGHT THERE WAS POSSIBLY A PROBLEM WITH THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369819 ↗
• MalfunctionNov 30, 2023Separation Failure; Material Deformation; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS UNABLE TO BE DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4.2 MM AND A 2.4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE AXIUM COIL WAS UNABLE TO DETACH DURING AXIUM PUSH PROCESS. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER THREE TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS THREE MANUAL ATTEMPTS AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE AN 8F COOK SHEATH, TONGBRIDGE 6F GUIDE CATHETER, ECHELON MICROCATHETER, SYNCHRO2 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237895 ↗
• MalfunctionJan 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  NEW INFORMATION WAS RECEIVED. THE ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE PREMATURE DETACHMENT WAS USING A SOLITAIRE STENT TO RETRIEVE THE COIL. THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED. THERE WERE NO DETACHMENT ATTEMPTS MADE. THE DOCTOR THOUGHT HE HAD PULLED IT OUT BUT THE COIL WAS PUSHED OUT WITH THE NEXT COIL. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215596 ↗
• MalfunctionSep 20, 2021Therapy Delivered to Incorrect Body Area; Separation Failure; Therapy Delivered to Incorrect Body Area; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SAME INSTANT DETACHER WAS USED WITH OTHER COILS IN THE CASE WITHOUT ANY PROBLEMS. PRIOR TO THE NON-DETACHMENT THERE HAD BEEN NO ISSUES, AND NO DAMAGE WAS OBSERVED TO THE PUSHWIRE AFTER IT WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496732 ↗

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