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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000845797), received between Mar 5, 2026 and Mar 5, 2026 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE THE AXIUM COIL WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH A MAX DIAMETER OF 2.4 MM AND A 1.5 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED FOR A SUBARACHNOID HEMORRHAGE FROM AN ACOM ANEURYSM. DURING THE PROCEDURE, THE COIL WAS SEATED PROPERLY IN THE ANEURYSM WITHOUT ANY TROUBLE, HOWEVER, IT WOULD NOT DETACH USING THE DETACHER. THE COIL WAS MANUALLY BROKEN AT THE DETACHMENT ZONE, HOWEVER, WOULD NOT ACTUALLY DETACH. THE PHYSICIAN WAS ABLE TO PULL THE ENTIRE COIL INTO THE SL 10 CATHETER, HOWEVER, ONCE IT WAS IN THE CATHETER IT DETACHED. THE PHYSICIAN WAS ABLE TO PULL THE CATHETER WITH THE COIL INSIDE OUT OF THE PATIENT WITHOUT ANY TROUBLE. THE PATIENT¿S TORTUOSITY WAS NOTED AS SEVERE, HOWEVER, THE PHYSICIAN DID NOT BEND OR USE EXCESSIVE PUSH TO GET THE COIL TO THE ANEURYSM. AFTER THE COIL AND CATHETER WERE REMOVED FROM THE PATIENT, THE PATIENT RE-RUPTURED ON THE TABLE. THE PHYSICIAN WAS ABLE TO GO BACK UP AND PLACE A FEW AXIO

  Patient problems: Intracranial Hemorrhage; Ruptured Aneurysm

  MAUDE report 24523666 ↗