Axium Prime Detachable Coil System APB-4-6-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536038219), received between Nov 1, 2024 and Mar 30, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionMar 30, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR LEFT POSTERIOR COMMUNICANT SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3.8MM AND A 3.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AXIUM COIL ENCOUNTERED RESISTANCE AND STUCK IN SHEATH. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS RESISTANCE IN TWO COILS. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS CARRIED OUT ACCORDING TO WHAT WAS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THE PROCEDURE WAS COMPLETED BY OPENING THE SHEATH, IMMERSING IT IN SALINE SOLUTION, AND PROCEED TO RAISE IT THROUGH THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716038 ↗
• MalfunctionNov 1, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AXIUM COIL NON-DETACHMENT. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A PERCUTANEOUS ANTERIOR COMMUNICATING (ACOM) ARTERY  ANEURYSM STENT-ASSISTED COIL EMBOLIZATION. AFTER THE COIL WAS DELIVERED, IT COULD NOT BE DETACHED. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE SUCCESSFULLY. THE CAUSE OF THE COIL NON-DETACHMENT WAS INITIALLY CONSIDERED TO LIKELY BE A PROBLEM WITH THE COIL PUSHER WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586873 ↗

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