Axium Detachable Coil System QC-5-20-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536037427), received between Oct 13, 2022 and Nov 4, 2025 — classified as 2 deaths, 5 malfunctions.

The most frequently reported specific device problem is “Stretched” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL EXPERIENCED RESISTANCE IN THE ECHELON CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 10 MM DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND THE VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT AFTER THE ECHELON MICROCATHETER WAS POSITIONED, AN ATTEMPT WAS MADE TO DELIVER THE AXIUM COIL, BUT THE COIL COULD NOT COME OUT, AND SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING DELIVERY. THE SURGEON INDICATED THAT THERE MIGHT BE ISSUES WITH BOTH THE MICROCATHETER AND THE COIL. AFTER REPLACING THE MICROCATHETER, THE COIL WAS SUCCESSFULLY DELIVERED. THE SURGEON ATTEMPTED TO RE-DELIVER THE FIRST AXIUM COIL INTO THE ANEURYSM BUT FOUND THAT THE COIL WAS ALREADY DEFORMED. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTERWARD, BUT THE SURGEON INDICATED THAT BOTH PRODUCTS HAD ISSUES. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468292 ↗
• DeathSep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT, THAT A PATIENT DEATH. THE PATIENT WAS UNDERGOING ANEURYSM TREATMENT, IMPLANTED SPRING COIL AND BLOOD FLOW DIVERSION DENSE MESH STENT. THE REPORTED, DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNKNOWN ANEURYSM. ANEURYSM DIMENSIONS, BLOOD FLOW AND TORTUOSITY WAS UNKNOWN. THE CAUSE OF THE PATIENT¿S DEATH WAS UNKNOWN. IT WAS UNKNOWN, IF DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS UNKNOWN. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED REPORTED, THAT THE DATE OF DEATH WAS UNKNOWN. THE CAUSE OF THE PATIENT¿S DEATH WAS UNKNOWN. NO EQUIPMENT MALFUNCTION, DURING THE OPERATION WAS IDENTIFIED. IT WAS UNKNOWN, IF THE PATIENT FOLLOWED THE DOCTOR'S INSTRUCTIONS AND TAKE RELEVANT MEDICATIONS AFTER THE OPERATION. ADDITIONAL, INFORMATION RECEIVED REPORTED, THAT THE PATIENT WAS BEING TREATED FOR AN INTERNAL CAROTID ARTERY ANEURYSM NEAR THE INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY. THE CAUSE OF DEATH WAS UNKNOWN. THE FULL PROCEDURE, COMPLICATIONS, DURING THE PROCEDURE. AND WHEN THE PATIENT DIED WAS UNKNO

  Patient problems: Insufficient Information; Unspecified Nervous System Problem

  MAUDE report 20217424 ↗
• DeathSep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT DEATH. THE PATIENT WAS UNDERGOING ANEURYSM TREATMENT, IMPLANTED SPRING COIL AND BLOOD FLOW DIVERSION DENSE MESH STENT. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNKNOWN ANEURYSM. ANEURYSM DIMENSIONS, BLOOD FLOW AND TORTUOSITY WAS UNKNOWN. THE CAUSE OF THE PATIENT¿S DEATH WAS UNKNOWN. IT WAS UNKNOWN IF DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS UNKNOWN. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. 2024-AUG-19 E1 (FOR, REP, HCP): ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DATE OF DEATH WAS UNKNOWN. THE CAUSE OF THE PATIENT¿S DEATH WAS UNKNOWN. NO EQUIPMENT MALFUNCTION DURING THE OPERATION WAS IDENTIFIED. IT WAS UNKNOWN IF THE PATIENT FOLLOWED THE DOCTOR'S INSTRUCTIONS AND TAKE RELEVANT MEDICATIONS AFTER THE OPERATION. 2024-09-04 E2 (FOR, REP, HCP): ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BEING TREATED FOR AN INTERNAL CAROTID ARTERY ANEURYSM NEAR THE INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY. THE CAUSE OF DEATH WAS UNKNOWN. THE FULL PROCEDURE, COMPLICATIONS DUR

  Patient problems: Insufficient Information; Unspecified Nervous System Problem

  MAUDE report 20213611 ↗
• MalfunctionJan 30, 2024Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS FOUND STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) C6 SEGMENT WITH A MAX DIAMETER OF 6 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM COIL WAS UNPACKED AND HYDRATED. THE COIL WAS STRETCHED AND THEN IT WAS REPLACED TO COMPLETE THE PROCEDURE. 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 THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607420 ↗
• MalfunctionAug 30, 2023Separation Failure; Separation Failure

  2023-AUG-28 MPXR 1092053 (REP, HCP, FOR): MEDTRONIC RECEIVED A REPORT THAT THE AXIUM SPRING COIL COULD NOT BE DETACHED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT TWO TIMES. THERE WAS THREE ATTEMPTS MADE TO DETACH THE AXIUM COIL MANUALLY. 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 7MM AND A 6MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL ANDVESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO PUSH WIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17657047 ↗
• MalfunctionFeb 8, 2023Break; Therapy Delivered to Incorrect Body Area; Stretched; Detachment of Device or Device Component; Break; Therapy Delivered to Incorrect Body Area; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THE TIP WAS DRAWN WIRE AND IT WAS DETACHED PREMATURELY. THE COIL DID NOT PREMATURELY SEPARATE FROM TH THE DELIVERY WIRE. PART OF THE COIL DID NOT FRACTURE OR SEPARATE FROM THE REST. SURGEON SAID THAT USAGE PROCESS WAS THE SAME AS BEFORE. NO FURTHER ACTIONS ARE PLANNED TO RESOLVE THE EVENT. AFTER SURGERY, THE SURGEON SAID IT SHOULD BE OBSERVED FIRST, AND THERE ARE CURRENTLY NO OTHER MEASURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326563 ↗
• MalfunctionOct 13, 2022Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPRING COIL WAS PARTIALLY BROKE AND STRETCHED. THE COIL DID NOT PREMATURELY SEPARATE FROM THE DELIVERY WIRE. PART OF THE COIL WAS SEPARATED FROM THE REST. THERE WERE NO OTHER ISSUES. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE ENTIRE COIL WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598000 ↗

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