Axium QC-9-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00836462010451), received between Feb 26, 2019 and Jan 25, 2024 — classified as 1 injury, 5 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 16, 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.

• MalfunctionJan 25, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DID NOT DETACH AFTER IT WAS PLACED INTO THE ANEURYSM DESPITE USING THE MANUAL BREAK.  IT WAS REPORTED NON-DETACHMENT OCCURRED. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM WITH A MAX DIAMETER OF 9 MM AND A 9 MM NECK DIAMETER. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584118 ↗
• MalfunctionNov 17, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT TWO COILS HAD RESISTANCE/STUCK IN SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS 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 AFTER IT WAS WITHDRAWN, THE PUSH ROD WAS PULLED OUT AND IT WAS FOUND THAT THE COIL WAS BROKEN IN THE LEATHER SHEATH.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 COILS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814162 ↗
• MalfunctionMay 13, 2021Stretched; Separation Failure; Detachment of Device or Device Component; Stretched; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED CONFIRMATION THAT THERE WAS NO EFFECT ON THE PATIENT RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820559 ↗
• MalfunctionSep 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING ANEURYSM COIL EMBOLIZATION, THE AXIUM COIL HAD EARLY DETACHMENT. A SOLITAIRE AB WAS THEN USED TO RETRIEVE THE COIL AND REMOVE IT FROM THE PATIENT. IT WAS UNKNOWN IF THERE WAS ANY FRICTION, IF THE PUSHWIRE WAS DAMAGED, IF THERE WAS REPOSITIONING, ATTEMPTS TO DETACH THE COIL, ROTATION OF THE PUSHWIRE, OR IF A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. IT WAS ALSO UNKNOWN IF THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED, BUT THE PATIENT STATUS WAS UNKNOWN. ANCILLARY DEVICES INCLUDE AN ECHELON MICROCATHETER, SOLITAIRE AB, REBAR 27, FOUR OTHER COILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10493910 ↗
• MalfunctionMar 23, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE BASILAR TOP WITH A MAX DIAMETER OF 10MM AND A 4.2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL WAS POSITIONED WELL IN THE ANEURYSM, BUT WOULD NOT DETACH. THE INSTANT DETACHER WAS USED TWICE, ANOTHER INSTANT DETACHER WAS USED TWICE, AND NO MANUAL DETACHMENT METHOD WAS USED. THE COIL WAS REPLACED BY ANOTHER PRODUCT TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9869728 ↗
• InjuryFeb 26, 2019Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION THAT THE IMPLANT COIL PREMATURELY DETACHED AS IT WAS BEING HALFWAY DELIVERED INTO THE ANEURYSM. THE PHYSICIAN USED THE GUIDEWIRE TO PUSH PART OF THE COIL INTO THE DESIRED LOCATION; HOWEVER, A SMALL PART OF THE COIL WAS IN THE PARENT VESSEL. THE PHYSICIAN USED A STENT TO PRESS THE COIL AGAINST THE VESSEL WALL AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF A RUPTURED SACCULAR ANEURYSM MEASURING 12.1MM X 3.8MM LOCATED IN THE A3 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). THE PATIENT¿S VASCULATURE WAS MINIMAL IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO DIFFICULTY OR FRICTION DURING DELIVERY AND THE PHYSICIAN DID NOT REPOSITION THE COIL. CONTINUOUS FLUSH WAS ADMINISTERED AND THERE WAS NO ROTATION OF THE PUSHWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8372255 ↗

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