Axium Detachable Coil System QC-2-6-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00847536037632), received between Mar 10, 2022 and Jun 30, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (10 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Difficult or Delayed Positioning; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS ENCOUNTERED DIFFICULT PLACEMENT. IT WAS REPORTED THAT THE 2-6 COIL WAS ADVANCED BUT COULD NOT BE PLACED IN. IT WAS REPLACED WITH A 2-4 COIL, BUT THE 2-4 COIL SILL COULD NOT BE PLACED IN. THEN A 1.5 MM PRIME COIL WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. THE DEVICES DID NOT JUMP DURING DEPLOYMENT AND THE VESSEL WAS NOT DAMAGED. THE TIP OF THE CATHETER WAS UNDER STRESS FOR THE 2-4 COIL, BUT NOT FOR THE 2-6 COIL, AND THE CATHETER MOVED DURING DEPLOYMENT. THE PHYSICIAN ROTATED THE 2-6 COIL DELIVERY PUSHER DURING THE PROCEDURE. THE ANEURYSM DID NOT RUPTURE. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE VESSEL TORTUOSITY WAS NORMAL. THE PATIENT EXPERIENCED NO ADVERSE REACTIONS RELATED TO THE EVENT. THE CAUSES OR CONTRIBUTING FACTORS FOR THE DIFFICULT PLACEMENT AND CATHETER MOVEMENT COULD NOT BE DETERMINED. THE USED CATHETER WAS AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25672610 ↗
• MalfunctionJan 16, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING DELIVERY OF AN AXIUM COIL IT ENCOUNTERED RESISTANCE AND DETACHED AUTOMATICALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR INTERVENTIONAL EMBOLIZATION SURGERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PATIENT HAD UPPER GASTROINTESTINAL BLEEDING AND UNDERWENT VARICEAL EMBOLIZATION. DURING THE DELIVERY OF THE COIL WITH THE MICROCATHETER THERE WAS SIGNIFICANT RESISTANCE MAKING ADVANCEMENT DIFFICULT. UPON WITHDRAWAL, THE COIL DETACHED AUTOMATICALLY. ANOTHER COIL WAS THEN USED INSTEAD TO COMPLETE THE EMBOLIZATION. 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. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE CATHETER USED WAS NOT A MEDTRONIC PRODUCT. RESISTANCE WAS ENCOUNTERED IN THE MIDDLE SECTION OF THE CATHETER. A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL DETACHED BUT DID NOT REMAIN IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093241 ↗
• MalfunctionNov 22, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE PUSH INTO THE ECHELON CATHETER. THE DOCTOR CHANGED ANOTHER ECHELON AND DEPLOYED THE OTHER COIL SUCCESSFULLY. IT WAS REPORTED THERE WAS CATHETER RESISTANCE AT THE HUB. THE TIP OF THE SHEATH WAS SEATED SECURELY IN THE HUB. IT WAS REPORTED THERE WAS CATHETER AND COIL DAMAGE OBSERVED. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. 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. THE PATIENT WAS UNDERGOING TREATMENT FOR A BRAIN ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625700 ↗
• MalfunctionAug 6, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT ONE AXIUM COIL COULD NOT BE DETACHED AND ANOTHER AXIUM COIL HAD RESISTANCE AND WAS STUCK IN THE ECHELON 10 MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR EMBOLIZATION TREATMENTOF A SACCULAR ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.9 MM AND A 4.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE ECHELON-10 MICROCATHETER WAS POSITIONED INTO THE ANEURYSM CAVITY WITH THE HELP OF A MICROGUIDEWIRE. THE AXIUM FILLING COILS QC-5-15-3D AND QC-3-8-3D WERE SUCCESSFULLY DELIVERED THROUGH THE ECHELON10 EMBOLIZATION MICROCATHETER WITH THE SUPPORT OF THE NAVIEN CATHETER AND THE MICROGUIDEWIRE. AN AXIUM QC-2-6-3D COIL WAS THEN DELIVERED TO THE ANEURYSM, HOWEVER, DURING THE DELIVERY PROCESS, IT WAS FOUND THAT THE COIL COULD NOT BE DETACHED. IT IS UNKNOWN IF THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER OR HOW MANY DETACHMENT ATTEMPTS WERE MADE USING THE INSTANT DETACHER, HOWEVER, IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE INSTANT DETACH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729283 ↗
• MalfunctionJun 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE ANEURYSM PREPARATION PROCESS, THE STENT WAS FULLY HYDRATED AND WAS ABOUT TO BE DELIVERED TO THE LESION THROUGH THE MICROCATHETER. HOWEVER, THE RESISTANCE GRADUALLY INCREASED AFTER ENTERING THE MICROCATHETER UNTIL IT COULD NOT BE PUSHED. AFTER BEING WITHDRAWN FROM THE BODY AND REHYDRATED, THE PROBLEM STILL EXISTED. THE 6-30 STENT WAS REPLACED AND THE PROBLEM WAS SOLVED. THERE WAS RESISTANCE DURING PREP. THE STENT WAS ABLE TO BE PUSHED OUT OF THE SHEATH. THERE WAS RESISTANCE IN THE SHEATH. DURING THE NORMAL ANEURYSM FILLING PROCESS, THE QC-2-6-3D COIL WAS USED AT THE END, BUT THE MICROCATHETER COULD NOT BE INSERTED AT THE SL-10 HUB. AFTER MULTIPLE ATTEMPTS, IT COULD NOT BE INSERTED, THERE WAS RESISTANCE. THE SURGERY WAS COMPLETED AFTER REPLACING WITH THE COIL OF OTHER MANUFACTURER. THERE WAS COIL RESISTANCE/STUCK IN SHEATH. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE 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 RIGHT INTERNAL CAROTID ARTERY C6 SEGMENT LATERAL WALL ANEURYSM WITH A MAX DIAMETER OF 5 MM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128233 ↗
• MalfunctionJun 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT 2 AXIUM COILS WERE STUCK IN THE CATHETER. THE DOCTOR PREPARED AND CANNULATED THE ARTERY TO TREAT AN ANEURYSM IN THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA), FOR WHICH WHEN PASSING THE QC-2-6-3D COIL IT DOES NOT ADVANCE THROUGH THE HYPOTUBE FOR PASSAGE THROUGH THE MICROCATHETER. IT WAS REPORTED THE COIL WAS STUCK IN THE CATHETER HUB AND IT WAS ALSO STUCK IN THE DISTAL SECTION OF THE CATHETER. THE CATHETER AND COILS WERE NOT DAMAGED. THE APB-2-4-3D-ES COIL WAS STUCK IN AN ECHELON CATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, FUSIFORM ANEURYSM IN THE PICA. THE MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT INJURY OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER RESISTANCE WAS IN THE HUB. THE COILS CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE CATHETER WAS A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126929 ↗
• MalfunctionApr 30, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS ENCOUNTERED RESISTANCE AT THE HUB OF THE ECHELON CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT THE AXIUM COIL WAS STUCK IN ECHELON HUB AND THE COIL STRETCHED. IT WAS CHANGED TO ANOTHER AXIUM COIL BUT WAS STILL STUCK. THE ECHELON WAS CHANGED TO ANOTHER MICROCATHETER (NON-MEDTRONIC CATHETER) WHICH WORKED. THE TIP OF THE SHEATH WAS SEATED SECURELY IN THE HUB. THE IMPLANT COIL WAS PUSHED OUT SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THE CATHETER WAS NOT DAMAGED. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE RESISTANCE AND COIL STRETCH MIGHT BE DUE TO THE DESIGN OF THE HUB OF ECHELON. THE RESISTANCE WAS IN THE HUB OF THE CATHETER. THE SECOND AXIUM COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936768 ↗
• MalfunctionMar 17, 2025Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  IT WAS REPORTED THAT DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE FOR AN UNRUPTURED SACCULAR ANTERIOR CEREBRAL ARTERY ANEURYSM. THE MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 4MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. THE BARE AXIUM 3D COIL WAS FOUND DETACHED WHEN THE PACKAGE WAS OPENED. THE COIL WAS REPLACED WITH A NEW COIL DURING THE OPERATION, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620232 ↗
• MalfunctionMar 17, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620047 ↗
• MalfunctionAug 28, 2024Break; Stretched; Break; Stretched

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS DAMAGED AND BROKEN. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANTERIOR CIRCULATION ANEURYSM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY BUT THE COIL WAS OBSERVED TO BE STRETCHED DURING THE FILLING PROCESS. THE COIL WAS REMOVED AND IT WAS NOTED THE COIL WAS BROKEN OR PREMATURELY DETACHED. THE PHYSICIAN HAD NOT ATTEMPTED TO DETACH THE COIL AND DID NOT ROTATE THE PUSHER WIRE DURING THE PROCEDURE. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INTERVENTION WAS REQUIRED. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICE: ECHELON MICROCATHETER (MODEL/LOT UNKNOWN)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086322 ↗
• MalfunctionAug 8, 2024Stretched; Separation Failure; Stretched; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE DETACHED. WHEN REMOVED FROM THE BODY, IT WAS FOUND TO BE STRETCHED. A REPLACEMENT COIL WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY. 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 A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939731 ↗
• MalfunctionJun 17, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL HOOP COULD NOT BE FORMED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5.2 MM AND A 2.9 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT FOR RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM, AFTER THE MICROCATHETER WAS DELIVERED INTO PLACE THROUGH THE GUIDE WIRE, QC2-6-3D WAS USED AS THE COIL TO FORM THE HOOP. AFTER REPEATED ADJUSTMENTS AFTER ENTERING THE ANEURYSM, THE HOOP COULD NOT BE FORMED, SO IT WAS REMOVED FROM THE BODY AND REPLACED WITH A NEW QC2-6 SPRING COIL, AND THEN THE HOOP WAS FORMED 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 WAS RECEIVED THAT THE CAUSE OF THE POOR SHAPE/INABILITY TO FORM A HOOP WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19551605 ↗
• MalfunctionApr 15, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT AFTER TAKING OUT THE COIL THAT COULD NOT BE DETACHED, THE COIL WAS REPLACED AND FILLED, AND THE DETACHMENT WAS SUCCESSFULLY ACHIEVED. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105325 ↗
• MalfunctionApr 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING THE COIL FILLING PROCESS, THE SPRING COIL WAS FOUND TO BE AUTOMATICALLY DETACHED IN THE MICROCATHETER DURING RETRIEVAL AND ADJUSTMENT. THE SURGEON IMMEDIATELY REMOVED THE MICROCATHETER AND THE COIL FROM THE BODY. NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL ONCE. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE OPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 5MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19012715 ↗
• MalfunctionMar 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE IN THE CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 4 MM AND A 6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PATIENT HAD AN ANEURYSM OF THE OPHTHALMIC ARTERY SEGMENT, THE ANEURYSM BODY WAS 4 MM X 6MM, AND THE DIAMETER WAS 2.5MM. THE MICROCATHETER WAS IN PLACE, AND COILS WERE IMPLANTED IN TURN, ONE 3 X 8, 2-6. WHEN THE SECOND SPRING COIL WAS IMPLANTED, IT WAS FOUND THAT THE COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER. IT STILL COULD NOT BE PUSHED OUT EVEN AFTER REPEATED OPERATIONS. FINALLY, A NEW COIL WAS REPLACED, AND THE PROBLEM WAS SOLVED. THEN ONE 2X4 AND ONE 1X3 WERE FILLED IN TURN, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THERE WAS CATHETER RESISTANCE /STUCK IN CATHETER. THERE WAS NO CATHETER DAMAGE OBSERVED. 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. ADDITI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933129 ↗
• MalfunctionNov 22, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CATHETER RESISTANCE WAS IN THE HUB. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY, WHEN THEY SUCCESSFULLY WITHDREW IT FROM THE INTRODUCTION SHEATH, IT WAS FOUND THAT THE COIL BODY HAD BEEN DETACHED AUTOMATICALLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191979 ↗
• InjurySep 20, 2023Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Migration; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT DUAL ANTIPLATELET TREATMENT (DAPT) WAS NOT ADMINISTERED BEFORE THE PROCEDURE. HOWEVER, THE PATIENT WAS TREATED WITH A DAPT REGIMEN (ASPIRIN AND CLOPIDOGREL) POST-OPERATIVELY. IT WAS NOTED THAT, "DURING THE OPERATION, INTERVENTION WAS PERFORMED THROUGH GUIDE WIRE AND STENT, HOPING THAT THE EXPOSED [COIL] WOULD RETURN TO ITS ORIGINAL POSITION."

  Patient problems: Cerebral Edema; Cognitive Changes; Ischemia Stroke; Thrombosis/Thrombus; Visual Impairment

  MAUDE report 17785017 ↗
• MalfunctionFeb 13, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL COULD NOT BE PUSHED OUT OF THE SHEATH. IT WAS NOTED THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A PROCEDURE TO TREAT AN UNRUPTURED SACCULAR LEFT CAROTID OPHTHALMIC ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 7.3MM AND THE NECK DIAMETER WAS 4.9MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THERE WAS NO DAMAGE OBSERVED TO THE COIL, COIL PUSHWIRE, OR THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363136 ↗
• MalfunctionDec 29, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT FIRST, THE AVIGO GUIDE WIRE GUIDED ECHELON10 CATHETER IN PLACE, AND THEN THE QC-8-30-3D WAS FIRST IMPLANTED TO FORM A HOOP, AND THEN THE SECOND COIL 7-20-3D WAS SMOOTHLY PUSHED, AND THE THIRD COIL 6-20-3D WAS SUCCESSFULLY IMPLANTED. 5-15-3D, 4-12-3D WERE IMPLANTED IN SEQUENCE. THEN QC-2-6-3D WAS IMPLANTED INTO THE MICROCATHETER SMOOTHLY, AND THEN IT WAS READY FOR DETACHMENT AFTER ENTERING THE ANEURYSM. THE SURGEON COULDN'T DETACH IT WITH THE INSTANT DETACHMENT DEVICE, AND THE SURGEON BROKE IT OFF IN THE DETACHMENT AREA TO DETACH IT. TWO ATTEMPTS TO DETACH THE COIL WITH THE INSTANT DETACHER (ID) HAD BEEN MADE. THE PHYSICIAN DID NOT TRY ANOTHER ID. 3 MANUAL ATTEMPTS WITH A HYPOTUBE WAS MADE, THERE WAS NO ISSUE WITH THE ID. AFTER THE INNER CORE WAS COMPLETELY WITHDRAWN, THE COIL WENT OUT TOGETHER WITH THE DELIVERY GUIDE WIRE WHEN REMOVING THE DELIVERY GUIDE WIRE, AND IT WAS WITHDRAWN INTO THE MICROCATHETER WITHOUT BEING DETACHED. THE COIL WAS REMOVED. AFTER REPLACING IT WITH THE COIL QC-2-4-3D, IT WAS SUCCESSFULLY DETACHED. AFTER THAT, IMPLANTED THE QC-2-4-3D COIL AGAIN TO ANEURYSM, AND THIS PROCESS WENT SMOOTHLY, AND THE EMBOLIZATION WAS COMPLETED, AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16070752 ↗
• MalfunctionSep 8, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURE AFTER FAILING TO DETACH WHEN ATTEMPTED AND THE ECHELON CATHETER WAS DAMAGED. THAT PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT MIDDLE CEREBRAL ARTERY BRAIN ANEURYSM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS NOTED THE ECHELON CATHETER WAS SHAPED WITH STEM. WHEN THE COIL WAS POSITIONED IN THE ANEURYSM, DETACHMENT WAS TRIED TWICE AND THE COIL SEEMED TO BE DETACHED BUT THE WHEN DOCTOR REMOVED THE PUSHED, THE COIL FELL OFF IN THE PATIENT'S VESSEL. A SOLITAIRE WAS USED TO RETRIEVE THE COIL. IT WAS ALSO REPORTED THAT THE DISTAL END OF THE ECHELON CATHETER APPEARED CRUSHED. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE EVENT DID NOT EXTEND THE PATIENT'S HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15385554 ↗
• MalfunctionApr 13, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS PRE IT WAS FOUND THAT THE COIL COULD NOT PUSH OUT OF THE DELIVERY ROD TIP. IT WAS DETERMINED THE PART WAS NOT RUPTURED AND NO ACTIVE INTERVENTION WAS NEEDED. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2.16MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14093050 ↗
• MalfunctionMar 10, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL FAILED TO DETACH. THE PATIENT WAS BEING TREATED FOR A POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE MAX DIAMETER WAS 5.1MM AND THE NECK DIAMETER WAS 3.0MM. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  AFTER THE QC-2-6-3D COIL WAS IMPLANTED INTO THE TUMOR, IT COULD NOT BE DETACHED. THE SURGEON HAD ALREADY WITHDRAWN ALL THE DETACHMENT WIRES, BUT IT STILL COULD NOT BE DETACHED. AND USED THE TWIST CONTROLLER, TWISTED THE DELIVERY ROD FOR A LONG TIME, IT STILL COULD NOT BE DETACHED. THE PHYSICIAN TRIED TO DETACH THE COIL WITH THE INSTANT DETACHER 1 TIME. 1 MANUAL ATTEMPT AT DETACHMENT WAS MADE WITH THE HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727332 ↗

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