Axium Detachable Coil System QC-10-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536037519), received between Apr 18, 2022 and Feb 18, 2025 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE AND WAS STUCK IN THE DISTAL SECTION OF THE ECHELON MICROCATHETER.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY C6 SEGMENT WITH A MAX DIAMETER OF 10MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER THE MICROCATHETER WAS IN PLACE, THE QC-10-30-HELIX COIL WAS SELECTED FOR DELIVERY. THE RESISTANCE IN THE MICROCATHETER WAS LARGE, AND THE COIL WAS PARTIALLY DAMAGED WHEN IT WAS REMOVED. THE CATHETER WAS NOT DAMAGED. ANOTHER COIL WAS USED TO CONTINUE AND COMPLETE THE SURGERY. 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.  ANCILLARY DEVICES INCLUDE AN ECHELON MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS STRETCHED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395299 ↗
• 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 UNKNOWN. THE PO

  Patient problems: Insufficient Information; Unspecified Nervous System Problem

  MAUDE report 20217400 ↗
• InjuryApr 18, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY AFTER NON-DETACHMENT AND REQUIRED MEDICAL INTERVENTION TO REMOVE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE MAX DIAMETER WAS 16MM AND THE NECK DIAMETER WAS 10MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  THE DOCTOR FOUND AN ECHELON MICROCATHETER INSIDE THE ANEURYSM, A BYPASS FLOW DIVERTER HAD ALREADY BEEN PLACED IN THE ARTERY BECAUSE THE NECK OF THE ANEURYSM WAS VERY LARGE, WHEN HE WAS PLACING THE LAST MEDTRONIC COIL HE DID NOT RELEASE DESPITE USING THE RELEASER COIL, WHEN RETRACTING THE PUSHER OF THE COIL, THE ENTIRE COIL COMES INTO THE PATIENT'S ARTERY AND IS RELEASED SPONTANEOUSLY IN THE ARTERY, REMAINING FLOATING IN THE ARTERY, WHILE COIL RECOVERY MANEUVERS WERE PERFORMED, A THROMBUS APPEARED IN THE ARTERY AND IN THE DIVERTER OCCLUDING THE ENTIRE MIDDLE BRAIN AND THE ANTERIOR BRAIN, THEY PLACED BOLUS TIROFIBAN AND IN CONTINUOUS INFUSION, IT WAS POSSIBLE TO REMOVE THE FRAGMENTED AND ENTANGLED COIL IN THE RECOVERY LOOP WITHOUT COMPLICATIONS AND

  Patient problems: Device Embedded In Tissue or Plaque; Thrombosis/Thrombus

  MAUDE report 14139260 ↗

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