Axium Prime Detachable Coil System APB-4-8-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536038226), received between Nov 1, 2023 and Aug 8, 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 8, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS HARD TO TAKE OUT THE COIL AS THERE WAS RESISTANCE DURING RETRIEVAL, PARTICULARLY AT THE DISTAL END. NO ISSUES WERE IDENTIFIED THAT DIRECTLY RESULTED IN THE DAMAGE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755304 ↗
• MalfunctionSep 29, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS DOING OKAY POST PROCEDURE AND TAKING ANTIPLATELET MEDS. THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20330604 ↗
• MalfunctionNov 1, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE PUSHED OUT. THE AXIUM WAS STUCK IN THE MIDDLE PORTION OF THE CATHETER. BOTH THE AXIUM COIL AND THE CATHETER WERE NOT DAMAGED. THE AXIUM AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 4MM AND A 3.2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049708 ↗

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