AxiumTM PC-5-15-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536033283), received between Jul 1, 2022 and Jul 1, 2022 — 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 16, 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.

• MalfunctionJul 1, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A AXIUM COIL HAD RESISTANCE AND DEPLOYED IN THE HUB OF THE ECHELON 10 CATHETER. THE PHYSICIAN WAS COILING THE ANEURYSM WITH FIBERED COILS. HE HAD PUT 10 COILS IN THROUGH THE ECHELON 10 WITH NO ISSUE. HE THEN TRIED TO ADVANCE THE PC-5-15-3D INTO THE ECHELON MICROCATHETER AFTER FLUSHING THE COIL, HE WAS ABLE TO GET 5CM OF THE PUSHER WIRE INTO THE MICROCATHETER BUT WITH RESISTANCE. HE THEN PULLED THE PUSHER WIRE BACK AND AS HE DID THAT, THE COIL DETACHED IN THE HUB OF THE MICROCATHETER. HE REMOVED THE COIL FROM THE HUB AND CONTINUED COILING THE ANEURYSM. THE PUSHER WIRE WAS NOT KINKED AND WILL BE RETURNED ALONG WITH THE COIL. NO MEDICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN DID NOT REPOSITION OR ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU).  THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR ANEURYSM IN THE CAVERNOUS RIGHT SIDED INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE MAX DIAMETER WAS 15MM AND THE NECK DIAMETER WAS 6MM. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14882145 ↗

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