Axium Detachable Coil System QC-4-12-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000320997), received between May 16, 2022 and Sep 8, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Break; Detachment of Device or Device Component; Unintended Movement; Migration; Break; Detachment of Device or Device Component; Unintended Movement; Migration

  ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 22998444 ↗
• MalfunctionJul 7, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS CATHETER RESISTANCE IN THE MIDDLE SEGMENT. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE COIL WAS KINKED, BUT NO DAMAGE TO THE CATHETER WAS OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22427717 ↗
• MalfunctionJun 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL FAILED TO PASS THROUGH THE ECHELON 10 HUB. THE IMPLANT COIL PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THERE WAS NO DAMAGE TO THE CATHETER AND COIL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 5MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS COMPLETED BY SWITCHING TO ANOTHER AXIUM. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207540 ↗
• MalfunctionMay 6, 2025Stretched; Stretched

  MEDTRONIC RECEIVED INFORMATION THAT INTRACRANIAL ANEURYSM EMBOLIZATION WAS BEING PERFORMED. AFTER THE MICROCATHETER WAS IN PLACE, THE DETACHABLE COIL QC-4-12-3D WAS SELECTED TO FORM A HOOP. THE TAIL ENDS OF TWO CONSECUTIVE COILS WERE STRETCHED AND REPLACED IT WITH ANOTHER NEW COIL, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCUALR ANEURYSM IN THE OPTHALMIC ARTERY. THE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTOUSITY WAS MINIMAL. NO PATIENT INJURY OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE NO ISSUES RESULTING IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970061 ↗
• MalfunctionMay 6, 2025Stretched; Stretched

  MEDTRONIC RECEIVED INFORMATION THAT INTRACRANIAL ANEURYSM EMBOLIZATION WAS BEING PERFORMED. AFTER THE MICROCATHETER WAS IN PLACE, THE DETACHABLE COIL QC-4-12-3D WAS SELECTED TO FORM A HOOP. THE TAIL ENDS OF TWO CONSECUTIVE COILS WERE STRETCHED AND REPLACED IT WITH ANOTHER NEW COIL, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCUALR ANEURYSM IN THE OPTHALMIC ARTERY. THE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTOUSITY WAS MINIMAL. NO PATIENT INJURY OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE NO ISSUES RESULTING IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970047 ↗
• MalfunctionMay 9, 2024Stretched; Separation Failure; Stretched; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN C4 WITH A MAX DIAMETER OF 3 MM AND A 2.6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. THE PATIENT'S PAST MEDICAL HISTORY INCLUDES HIGH BLOOD PRESSURE FOR SEVERAL YEARS, AND AN ANEURYSM. IT WAS REPORTED THAT THE AXIUM COIL COULD NOT BE DETACHED AND WAS THEN REMOVED. THE SURGERY WAS COMPLETED AFTER REPLACING IT WITH THE NEW SPRING COIL. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER TWO TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WERE TWO 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277695 ↗
• MalfunctionMar 20, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSION: MAX DIAMETER 6 MM AND NECK DIAMETER 4 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. THE TREATMENT PLAN WAS A STENT PLACEMENT PLUS A COIL EMBOLIZATION. THE CATHETER WAS SENT TO THE DISTAL END OF THE POSTERIOR INFERIOR CEREBELLAR ARTERY AND THE MICROCATHETER WAS INSERTED INTO THE ANEURYSM. THE AXIUM COIL WAS HYDRATED AND SENT INTO THE MICROCATHETER. WHEN DELIVERED INTO THE MICROCATHETER, THE SURGEON INDICATED THAT THERE WAS RESISTANCE AND WAS DIFFICULT TO PUSH. AFTER WITHDRAWING THE COIL, IT WAS FOUND THAT THE PROXIMAL PUSH ROD OF THE COIL WAS KINKED. THEN COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943327 ↗
• MalfunctionAug 31, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS UNABLE TO DEPLOY. THE AXIUM COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.2MM AND A 2.3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664334 ↗
• MalfunctionMay 16, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SURGEON USED THE COIL TO PERFORM ANEURYSM EMBOLIZATION. THE COIL COULD NOT BE PUSHED OUT FROM THE INTRODUCER SHEATH. INABILITY TO ENTERED THE MICROCATHETER DURING THE PROCESS (COULD NOT BE PUSHED OUT FROM THE INTRODUCER SHEATH). THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.6MM X 7.9MM AND A 2.3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT 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 16938655 ↗
• MalfunctionJun 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL PREMATURELY DETACHED. AFTER THE SPRING COIL WAS DEPLOYED, IT WAS ADJUSTED WITHOUT BEING DETACHED. WHEN RETRIEVED A PART OF THE SPRING COIL, IT WAS FOUND THAT THE SPRING COIL WAS DETACHED. THE PART OF THE SPRING COIL THAT HAD BEEN DETACHED AT THIS TIME WAS LOCATED IN THE INTERMEDIATE CATHETER, SO SAB WAS USED TO ENTER THE INTERMEDIATE CATHETER. THE DOCTOR OPENED THE STENT TO PRESS THE SPRING COIL AND WITHDREW THE WHOLE PART. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE POSTERIOR COMMUNICATING SEGMENT OF THE LEFT BRAIN. THE M AX DIAMETER WAS 5.2MM AND THE NECK DIAMETER WAS 3.5MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14784337 ↗
• MalfunctionMay 16, 2022Detachment of Device or Device Component; Unintended Movement; Physical Resistance/Sticking; Detachment of Device or Device Component; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE AND DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT MULTIPLE INTRACRANIAL ANEURYSMS IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM BEING TREATED WITH THE COMPLAINT COIL HAD A MAX DIAMETER OF 6MM AND NECK DIAMETER OF 4MM. 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). AN AXIUM COIL (MODEL: QC-6-20-3D) WAS USED TO FORM THE HOOP. THE COMPLAINT COIL (MODEL: QC-4-12-3D, LOT: 223109281) WAS THEN BEING USED FOR FILLING BUT THE MICROCATHETER WAS PUSHED OUT OF THE ANEURYSM. AN ATTEMPT WAS MADE TO RETRACT THE COIL AND REDELIVER THE MICROCATHETER INTO THE ANEURYSM BUT THERE WAS STRONG RESISTANCE WITH THE COIL IN THE MIDDLE OF THE MICROCATHETER DURING ATTEMPT TO RETRACT. AFTER SEVERAL ATTEMPTS, IT WAS FOUND THAT THE COIL HAD DETACHED FROM THE PUSHER. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407655 ↗

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