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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536038530), received between Aug 17, 2026 and Aug 17, 2026 — classified as 1 malfunction.

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

• MalfunctionAug 17, 2026Detachment of Device or Device Component

  Medtronic received a report that an Axium coil prematurely detached. The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the M2 Bifurcation Sinistra with a max diameter of 8mm and a 4mm neck diameter. It was noted the patient's blood flow was normal and vessel tortuosity was minimal. It was reported that the coil remains in the patient body. It was unknown if the coil was implanted at the intended location. Patient is alive and in good condition. No surgical or medicinal intervention was 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. A 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. Ancillary devices include an Avigo guidewire and Echelon microcatheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50272946 ↗

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