Axium QC-5-10-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00836462010369), received between Jul 11, 2017 and Oct 24, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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.

• MalfunctionOct 24, 2024Break; Separation Failure; Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WOULD NOT DETACH. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 6 MM AND NECK DIAMETER 3 MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND THE VESSEL TORTUOSITY WAS MODERATE. WHEN THE SURGEON USED THE COIL TO EMBOLIZE THE MIDDLE CEREBRAL ARTERY ANEURYSM, HE USED THE QC5-10-3D COIL. THE EMBOLIZATION WAS SATISFACTORY, AND WHEN HE WAS READY TO DETACH THE COIL, HE USED THE ALTERNATIVE DETACHMENT METHOD AND BROKE THE SPARE DETACHMENT POINT BY HAND AND FOUND THAT THE COIL WAS NOT DETACHED. HE PULLED OUT THE DETACHMENT WIRE FOR OBSERVATION AND FOUND THAT THE PROXIMAL END OF THE DETACHMENT WIRE WAS SHORT AND BROKE IN ADVANCE. THE PHYSICIAN USED STERILE NEEDLE-NOSED PLIERS TO TWIST OFF THE PROXIMAL PUSHER ROD, FOUND THE TAIL END OF THE BROKEN DETACHMENT WIRE IN THE PUSHER ROD AND PULLED IT OUT, AND THEN THE DETACHMENT WAS SUCCESSFUL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER. A MANUAL ATTEMPT AT DETACHMENT VIA HYPO

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 20521670 ↗
• MalfunctionFeb 10, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH WITH DETACHMENT ATTEMPTS AND THEN DETACHED PREMATURELY WITHIN THE CATHETER. THE PATIENT WAS UNDERGOING A PROCEDURE FOR COIL EMBOLIZATION TREATMENT OF A RUPTURED SPINDLE SHAPED ANEURYSM OF THE RIGHT ANTERIOR C OMMUNICATING ARTERY (A-COM) WITH A MAX DIAMETER OF 5MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL WAS THE FIRST USED IN THE TREATMENT OF THE A-COM ANEURYSM. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS DELIVERED BUT COULD NOT BE DETACHED. THREE DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER AND ONE MANUAL ATTEMPT WITH THE HYPOTUBE BUT ALL FAILED. WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL, IT DETACHED WITHIN THE CATHETER. THE WHOLE SYSTEM WAS REMOVED AND THE COIL WAS PROTRUDING 1CM FROM THE TIP FROM THE CATHETER TIP. THE SAME MICROCATHETER WAS USED WITH A NEW COIL OF THE SAME MODEL FROM A DIFFERENT LOT WHICH WAS SUCCESSFULLY IMPLANT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310320 ↗
• MalfunctionApr 9, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS INSERTED, BUT WHEN DETACHMENT WAS PERFORMED MORE THAN ONCE, IT FAILED. THE MANUAL DETACHMENT METHOD WAS PERFORMED MORE THAN ONCE, BUT IT ALSO FAILED. THE COIL THEN DETACHED DURING THE RETRIEVAL PROCESS, AND A SNARE WAS USED TO RETRIEVE THE COIL. 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 9945315 ↗
• MalfunctionJul 11, 2017Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT OF AN ANEURYSM, THIS COIL WOULD NOT DETACH WITH AN INSTANT DETACHER OR USING MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE). IT WAS REPORTED THAT THE PHYSICIAN TRIED WITH THE TWO INSTANT DETACHER AND THEN TRIED MANUAL METHOD BUT THE COIL DIDN'T DETACH. AFTER A LOT OF MANEUVERING, THE COIL FINALLY DETACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6703525 ↗

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