Axium Prime Detachable Coil System APB-4-6-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536038523), received between Feb 1, 2021 and Aug 19, 2025 — classified as 3 malfunctions.

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.

• MalfunctionAug 19, 2025Separation Failure; Migration; Separation Failure; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE AFTER REMOVAL. THE PROCEDURE WAS COMPLETED, COILS WERE ADDED. THE ANEURYSM SAC WAS SUCCESSFULLY FILLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843232 ↗
• MalfunctionJun 26, 2024Stretched; Stretched

  MEDTRONIC RECEIVED REPORT REGARDING THREE DIFFERENT AXIUM COILS THAT WERE STRETCHED DURING THE PROCEDURE. EACH TIME THE STRETCHED COIL WAS REPLACED AND THE REPLACEMENT COIL WAS IMPLANTED SUCCESSFULLY. IT WAS NOTED THAT ALL INVOLVED DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). PATIENT VESSEL TORTUOSITY WAS REPORTED TO BE NORMAL. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY OR POSITIONING. THE CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617758 ↗
• MalfunctionFeb 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING A COIL EMBOLIZATION PROCEDURE TO TREAT A PATIENT FOR AN UNRUPTURED ANEURYSM OF THE BASILAR ARTERY, THE AXIUM COIL WAS DETACHING PREMATURELY. THE COIL WAS PLACED IN THE ANEURYSM. THE PHYSICIAN TRIED TO REPOSITION THE COIL BUT THE COIL WAS DETACHING TOO EARLY SO THE PHYSICIAN LEFT THE COIL IN THE ANEURYSM AND COMPLETED DETACHMENT WITH THE INSTANT DETACHER TO ENSURE THE COIL REMAINED IN THE ANEURYSM AND DID NOT SLIP INTO ARTERY. IT WAS NOTED THAT THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OF THE COIL. THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL ONCE OR TWICE BUT HAD NOT ATTEMPTED TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE PUSHWIRE WAS NOT BENT OR BROKEN. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED. THERE WAS NO PATIENT SYMPTOMS OR INJURY ASSOCIATED WITH THE EVENT. THE COIL WAS ULTIMATELY IMPLANTED AT THE INTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258889 ↗

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