Axium Detachable Coil System QC-12-40-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536037960), received between Jul 20, 2022 and Apr 27, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Stretched; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO AXIUM COILS THAT HAD RESISTANCE AND WERE DAMAGED DURING DELIVERY IN AN ECHELON 10 MICRO CATHETER. THE PATIENT WAS UNDERGOING HEPATIC ARTERY COIL EMBOLIZATION PROCEDURE VIA FEMORAL ARTERY ACCESS. PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE ECHELON MICROCATHETER WAS IN PLACE AT THE TREATMENT LOCATION. THE FIRST COIL SELECTED QC-12-40-3D (LOT NUMBER 230184266). AFTER THE COIL WAS PREPARED AND HYDRATED, RESISTANCE WAS FELT WHEN ADVANCING THE COIL IN THE MIDDLE SEGMENT OF THE ECHELON MICROCATHETER AND THE MIDDLE OF THE PUSHER BECAME KINKED. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER QC-12-40-3D COIL (LOT NUMBER 230193615) WHICH WAS PREPPED AND HYDRATED. AGAIN, THERE WAS SIGNIFICANT RESISTANCE DURING DELIVERY. THE COIL STRETCHED IN THE MICROCATHETER. THE SYSTEM WAS THEM REPLACED AND THE PROCEDURE WAS COMPLETE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009420 ↗
• MalfunctionApr 27, 2026Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO AXIUM COILS THAT HAD RESISTANCE AND WERE DAMAGED DURING DELIVERY IN AN ECHELON 10 MICRO CATHETER. THE PATIENT WAS UNDERGOING HEPATIC ARTERY COIL EMBOLIZATION PROCEDURE VIA FEMORAL ARTERY ACCESS. PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE ECHELON MICROCATHETER WAS IN PLACE AT THE TREATMENT LOCATION. THE FIRST COIL SELECTED QC-12-40-3D (LOT NUMBER 230184266). AFTER THE COIL WAS PREPARED AND HYDRATED, RESISTANCE WAS FELT WHEN ADVANCING THE COIL IN THE MIDDLE SEGMENT OF THE ECHELON MICROCATHETER AND THE MIDDLE OF THE PUSHER BECAME KINKED. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER QC-12-40-3D COIL (LOT NUMBER 230193615) WHICH WAS PREPPED AND HYDRATED. AGAIN, THERE WAS SIGNIFICANT RESISTANCE DURING DELIVERY. THE COIL STRETCHED IN THE MICROCATHETER. THE SYSTEM WAS THEM REPLACED AND THE PROCEDURE WAS COMPLETE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009413 ↗
• MalfunctionAug 27, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 13.4 MM AND A 5.3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT ANGIOGRAPHY SHOWED THAT THE ANEURYSM WAS LOCATED IN THE LEFT POSTERIOR COMMUNICATING ARTERY, WITH A SIZE OF 13.4 MM X 11.2 MM AND A NECK OF 5.3 MM.  AN ECHELON10 MICROCATHETER WAS GUIDED BY THE GUIDEWIRE INTO PLACE, AND THEN THE FIRST QC-12-40-3D WAS FILLED, BUT IT COULD NOT BE PUSHED.  AFTER REPLACING THE PRODUCT WITH THE SAME MODEL, WHICH COULD PASS SMOOTHLY AND THE SURGERY WENT SMOOTHLY. 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. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE RESISTANCE WAS LOCATED IN THE DISTAL SECTION OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080096 ↗
• MalfunctionJul 26, 2024Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS WERE FOUND STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM SPRING COIL WAS STRETCHED. AFTER REPLACEMENT, IT WAS SUCCESSFULLY IMPLANTED. 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. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE COIL STRETCH WAS DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE CAUSE WAS UNDETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19842247 ↗
• MalfunctionMar 13, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ACCORDING TO THE SURGEON'S DESCRIPTION, EVERYTHING WENT SMOOTHLY DURING DELIVERY AND NO DIFFICULTIES WERE ENCOUNTERED. IT WAS JUST THAT THE DETACHMENT WAS DIFFICULT. ¿NO PUSHWIRE¿DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896162 ↗
• MalfunctionJul 20, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE DETACHED. ONE DETACHMENT ATTEMPT WAS MADE WITH THE INSTANT DETACHER (ID), AND 3 ATTEMPTS WERE MADE MANUALLY. A SECOND ID WAS NOT USED AS THERE WERE NO ISSUES WITH THE ID. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE C4 SECTION. THE MAX DIAMETER WAS 12MM, AND THE NECK DIAMETER WAS 8MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065102 ↗

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