Axium Detachable Coil System QC-8-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536037908), received between Dec 11, 2022 and Sep 3, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Break; Detachment of Device or Device Component; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50587415 ↗
• MalfunctionMar 12, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A BARE AXIUM 3D COIL (QC-8-30-3D) ENCOUNTERED RESISTANCE AND BECAME STUCK IN THE MIDDLE OF AN ECHELON 10 MICROCATHETER DURING DELIVERY, AND THE MIDDLE SEGMENT OF THE PUSHWIRE WAS FOUND TO BE KINKED. SINCE THE SAME MODEL COIL WAS UNAVAILABLE, THE COIL WAS REPLACED WITH A MEDTRONIC BARE AXIUM 3D COIL (QC-7-30-3D), HOWEVER, DELIVERY WAS STILL DIFFICULT, AND THE TIP OF THE COIL (PUSHWIRE DISTAL SEGMENT) WAS FOUND TO BE DAMAGED WHEN REMOVED. THE COIL WAS REPLACED WITH A NON-MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, HEPATIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 8 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY AND CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED. THE CAUSE OF THE RESISTANCE AND THE PUSHWIRE KINK WAS NOT DETERMINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582924 ↗
• MalfunctionJan 9, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AXIUM COIL FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED C6 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 9 MM AND A 3.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE AXIUM SPRING COIL COULD NOT BE DETACHED. AFTER REPLACING IT WITH ANOTHER SPRING COIL, THE DETACHMENT WAS SUCCESSFUL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE AXIUM COIL AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020356 ↗
• MalfunctionFeb 20, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED. THE PREMATURE DETACHMENT OF THE AXIUM WAS OBSERVED IMMEDIATELY AFTER TAKING THE COIL OUT FROM THE PACKAGE. THERE WAS PREPARATION COMPLETED TO THE COIL PRIOR TO NOTICING THE PREMATURE DETACHMENT. THERE WERE NO DETACHMENT ATTEMPTS MADE WITH THE INSTANT DETACHER OR VIA THE MANUAL METHOD. THERE WAS A KINK OBSERVED IN THE PUSHWIRE. THE AXIUM COIL WAS NOT IMPLANTED IN THE HUMAN BODY. ONLY 1 COIL WAS IMPLANTED BEFORE AND AFTER THIS COIL MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739168 ↗
• MalfunctionDec 11, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO COILS HAD RESISTANCE/STUCK IN SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AR TERIOVENOUS FISTULA. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AFTER THE PRE-OPERATIVE WORK PREPARATION WAS COMPLETED, THE SURGEON SELECTED AND USED THE ECHELON-10 MICROCATHETER TO FILL THE SPRING COIL. THE FIRST SEVERAL COILS WERE FILLED SMOOTHLY AND THE SURGEON SELECTED AND USED QC-9-30-3D. AFTER IT WAS HYDRATED, THE LEATHER SHEATH WAS ALIGNED WITH THE MICROCATHETER TO PUSH AND DELIVER THE SPRING COIL. AT THIS TIME, THE SURGEON INDICATED THAT THE PUSH RESISTANCE OF THE COIL WAS LARGE AND IT COULD NOT BE PUSHED OUT. AFTER IT WAS WITHDRAWN, THE PUSH ROD WAS PULLED OUT AND IT WAS FOUND THAT THE COIL WAS BROKEN IN THE LEATHER SHEATH. AFTER REPLACING WITH ANOTHER QC COIL OF THE SAME MODEL, IT COULD BE USED NORMALLY AND SMOOTHLY.  THEN, QC-8-30-3D WAS SELECTED AND USED, THE SAME PROBLEM WAS ENCOUNTERED, IT COULD NOT BE PUSHED OUT. LATER, MULTIPLE QC COILS WERE SELECTED AND USED, AND THE FILLING WENT SMOOTHLY, THE SURGERY WAS COMPLETED. THE SURGEON BELIEVED THAT THESE QC-9-30-3D, QC-8-30-3D COIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15956366 ↗

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