Axium Prime Detachable Coil System APB-5-10-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536038264), received between Nov 12, 2025 and Jan 15, 2026 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT A COIL SEPARATED/BROKE/PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 6MM AND A 2.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE OPERATOR DELIVERED THE COIL TO THE MIDDLE OF THE ECHELON CATHETER AND THE COIL STRETCHED. THE OPERATOR WITHDREW THE COIL TOGETHER WITH THE MICROCATHETER AND FILED A COMPLAINT. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. 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. ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THAT THE COIL PREMATURELY SEPARATED FROM THE DELIVERY WIRE. IT WAS UNKNOWN IF THE COIL F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086223 ↗
• MalfunctionNov 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL EXPERIENCED RESISTANCE IN THE ECHELON MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED ANEURYSM IN THE INTERNAL CERVICAL C5 ARTERY WITH A MAX DIAMETER OF 8 MM AND A 6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING THE ANEURYSM EMBOLIZATION COIL PROCEDURE, THE AXIUM COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER. IT WAS NOTED THAT OTHER MEDTRONIC COILS WERE FUNCTIONING NORMALLY. 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 8F CODIS GUIDE CATHETER, AN ECHELON MICROCATHETER, AND A SYNCHRO 14 GUIDEWIRE. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO REPORTED PROBLEM WITH THE CATHETER; RESISTANCE WAS EXPERIENCED BY THE COIL AT THE PROXIMAL END OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. AFTER REMOVAL, NO DAMAGE WAS FOUND TO THE CATHETER, AND ANOTHER COIL WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533530 ↗

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