Axium Detachable Coil System QC-8-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037472), received between Sep 13, 2024 and Sep 13, 2024 — classified as 2 deaths.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 20214991 ↗
• 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 UNKNOW

  Patient problems: Insufficient Information; Unspecified Nervous System Problem

  MAUDE report 20214312 ↗

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