Axium Detachable Coil System QC-2-4-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536037281), received between Aug 29, 2022 and Nov 25, 2025 — classified as 1 death, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Break; Difficult or Delayed Positioning; Migration; Break; Difficult or Delayed Positioning; Migration

  IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE WITH BALLOON REMODELING IN THE INTERNAL CAROTID ARTERY USING THE BARE AXIUM HELIX COIL, THERE WAS SIGNIFICANT INSTABILITY DURING COIL DEPLOYMENT DUE THE PATIENT¿S ANATOMY. THE EXCELSIOR MICROCATHETER CAME OUT OF THE ANEURYSM DURING THE PROCEDURE, REQUIRING THE COIL PUSHER TO BE USED AS A GUIDE TO REPOSITION THE COIL BACK INSIDE THE ANEURYSM BEFORE DETACHMENT. THE COIL MIGRATED AND CAME OUT OF THE ANEURYSM AGAIN AND WAS NOT IMPLANTED AT THE INTENDED LOCATION, NECESSITATING RETRIEVAL WITH A SOLITAIRE DEVICE. DIFFICULT PLACEMENT OF THE COIL WAS NOTED, AND THE TIP OF THE CATHETER WAS UNDER STRESS AND MOVED DURING DEPLOYMENT. THE DEVICE DID NOT JUMP DURING DEPLOYMENT, AND THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THERE WAS NO VESSEL DAMAGE AND THE ANEURYSM DID NOT RUPTURE. ADDITIONAL STEPS WERE REQUIRED TO SECURE THE COIL, INCLUDING CAPTURING IT WITH A STENT RETRIEVER. AFTER THE PROCEDURE, THE PATIENT DEVELOPED A HEADACHE, PROMPTING MAGNETIC RESONANCE IMAGING. A COMPUTED TOMOGRAPHY SCAN REVEALED A DISTAL MARKER WHICH WAS THOUGHT A MARKER OR ELEMENT FROM THE COIL DETACHED, THOUGH IT WAS NOTED THIS

  Patient problems: Foreign Body In Patient; Headache

  MAUDE report 23646474 ↗
• MalfunctionNov 4, 2025Stretched; Stretched

  MEDTRONIC RECEIVED INFORMATION REGARDING AXIUM COIL STRETCH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANTERIOR COMMUNICATING ARTERY SEGMENT UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4.3MM AND THE NECK DIAMETER WAS 3.4MM. PATIENT'S BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. DURING THE PUSHING/DELIVERY PROCESS, THE AXIUM IMPLANT COIL WAS STRETCHED. IT WAS NOTED THAT THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING TESTING OR DELIVERY OF THE COIL. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE TO CONTINUE THE PROCEDURE. IT WAS NOTED THAT THE SAME MICROCATHETER WAS USED WITHOUT ISSUE TO THE COMPLETION OF THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES: COOK 7F SHEATH, NAVIEN 6F CATHETER, ECHELON MICROCATHETER ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE ISSUES THAT RESULTED IN THE DAMAGE THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465678 ↗
• MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066703 ↗
• DeathAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS CONFIRMED THE PATIENT PASSED AWAY.

  Patient problems: Foreign Body In Patient; Hemorrhagic Stroke; Intracranial Hemorrhage; Obstruction/Occlusion

  MAUDE report 20009399 ↗
• MalfunctionDec 5, 2023Separation Failure; Material Deformation; Separation Failure; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES PRIOR TO NON-DETACHMENT, AND IT WAS OBSERVED THAT THE PUSHWIRE WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266219 ↗
• MalfunctionMar 24, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT VASCULAR TORTUOSITY WAS NORMAL. THE PATIENT'S PROGNOSIS WAS GOOD AND THERE WERE NO OTHER SPECIAL CIRCUMSTANCES. THE COIL HAD BEEN TAKEN OUT OF THE BODY, AND NOTHING ELSE HAD HAPPENED. AT PRESENT, THERE ARE NO OTHER SPECIAL CIRCUMSTANCES REPORTED BY CUSTOMERS. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS GOING HOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615098 ↗
• MalfunctionJan 3, 2023Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT REGARDING AN AXIUM COIL THAT HAD PREMATURELY DETACHED, STRETCHED, AND SEPARATED/BROKE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM IN THE RIGHT CAVERNOUS SINUS WITH A MAX DIAMETER OF 12.8 MM AND A 8.9 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SURGEON PERFORMED ANEURYSM EMBOLIZATION. AFTER THE MICROCATHETER WAS IN PLACE, THE COILS WERE FILLED. AFTER 8 COILS WERE PLACED, THE QC-2-4-HELIX COIL WAS SELECTED FOR FILLING. POSITION ADJUSTMENT WAS REQUIRED DURING EMBOLIZATION. THE COIL WAS STRETCHED DURING THE RE-RETRIEVAL ADJUSTMENT PROCESS AND COULD NOT BE FULLY RETRACTED INTO THE MICROCATHETER. THEN WHEN WITHDREW THE COIL, PUSH GUIDE WIRE AND MICROCATHETER AS A WHOLE, CONFIRMED THAT THE COIL HAD ACCIDENTALLY DETACHED AND REMAINED IN THE PARENT VESSEL. FINALLY, THE SURGEON USED A STENT TO PRESS THE COIL TO AVOID EXCESSIVE EXPOSURE OF THE COIL IN THE BLOOD VESSEL. THE SURGEON BELIEVED THAT THIS WAS A PRODUCT QUALITY PROBLEM AND REQUESTED TO RETURN IT, PLEASE IDENTIFY IT. IT WAS REPORTED COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087398 ↗
• InjuryAug 29, 2022Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME COIL WAS STUCK IN THE SHEATH, AND ANOTHER AXIUM COIL USED IN THE PROCEDURE PREMATURELY DETACHED . THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE LEFT CAVERNOUS SINUS SEGMENT. THE MAX DIAMETER WAS 12.8MM, AND THE NECK DIAMETER WAS 8.9MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT RESISTANCE WAS VERY LARGE AND THE COIL COULD NOT BE PUSHED INTO THE MICROCATHETER. AFTER THE COIL WAS WITHDRAWN AND THEY TRIED TO PUSH IN VITRO, BUT IT COULD NOT BE PUSHED OUT. A REPLACEMENT COIL ENTERED THE MICROCATHETER SMOOTHLY AND EMBOLIZED IN PLACE. DURING THE PROCEDURE OF EMBOLIZATION, WHEN THE SURGEON MADE THE RE-RECOVERY ADJUSTMENT, THE COIL AUTOMATICALLY STRETCHED DURING THE RECOVERY PROCESS AND COULD NOT BE COMPLETELY RECOVERED INTO THE MICROCATHETER. THEN, THE SURGEON DECIDED TO WITHDRAW THE MICROCATHETER AND THE COIL AS A WHOLE. DURING THE OVERALL WITHDRAWAL, IT WAS FOUND THAT THE COIL HAD BEEN DETACHED AND REMAINED IN THE INTRACAVITY OF THE TUMOR-BEARING ARTERY. FINALLY, THE SURGEON PRESSED THE COIL LEFT OUTSIDE THE ANEURYSM WITH A STENT. THE SURGEO

  Patient problems: Foreign Body In Patient

  MAUDE report 15316459 ↗

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