AXIUM NC-4-10-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462011106), received between Apr 4, 2019 and Apr 4, 2019 — 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 16, 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.

• DeathApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT OF PATIENT DEATH AFTER COILING. THE PATIENT PRESENTED WITH HEMORRHAGE. THE PATIENT HAD A RUPTURED, SACCULAR ANEURYSM. IT WAS REPORTED THAT THE PATIENT UNDERWENT COILING IN ORDER TO IMPROVE THE SITUATION. THE PATIENT UNDERWENT IMPLANTATION OF 13 COILS INCLUDING 9 MEDTRONIC COILS. THE PATIENT REPORTEDLY PASSED AWAY POST-PROCEDURE DUE TO THE MASSIVE HEMORRHAGE.

  Patient problems: Death

  MAUDE report 8483739 ↗
• DeathApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT OF PATIENT DEATH AFTER COILING. THE PATIENT PRESENTED WITH HEMORRHAGE. THE PATIENT HAD A RUPTURED, SACCULAR ANEURYSM. IT WAS REPORTED THAT THE PATIENT UNDERWENT COILING IN ORDER TO IMPROVE THE SITUATION. THE PATIENT UNDERWENT IMPLANTATION OF 13 COILS INCLUDING 9 MEDTRONIC COILS. THE PATIENT REPORTEDLY PASSED AWAY POST-PROCEDURE DUE TO THE MASSIVE HEMORRHAGE.

  Patient problems: Death

  MAUDE report 8483690 ↗

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