AxiumTM QC-3-8-3D (UDI 00847536017610)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536017610), received between Apr 10, 2019 and Jul 11, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 11, 2019Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE PUSHED INTO THE Y VALVE TO CONNECT TO THE MICROCATHETER. IT WAS NOTED THERE WAS FRICTION/DIFFICULTY DURING TESTING/DELIVERY. TRIED SEVERAL TIMES WITHOUT RESULT. THEN THE COIL WAS TAKEN OUT OF THE Y VALVE AND PUSHED OUT OF THE PROTECTIVE SHEATH. IT WAS FOUND THAT THE COIL HAD 2 BREAKS IN THE ANTI-UNWOUND WIRE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE, AND THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE COIL WAS HYDRATED AS PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS NOT NOTED TO HAVE BEEN DAMAGED PRIOR TO USE. NEW COIL DEVICES WERE USED TO TREAT THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED AT THE OPHTHALMIC SEGMENT OF INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3.8MM AND A NECK DIAMETER OF 3.6MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED/HYDRATED AS INDICATED IN THE IFU. THERE WAS NO KINK/DAMAGE SEEN ON THE CATHETER OR PUSHWIRE. TATE PATIENT WAS ULTIMATELY TREATED WITH REPLACEMENT COILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8780602 ↗
• MalfunctionApr 10, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE BARE AXIUM COIL FAILED TO DETACH FROM THE PUSHWIRE. THE PATIENT WAS UNDERGOING TREATMENT OF AN ANEURYSM WAS IN THE OPHTHALMIC ARTERY SEGMENTS, IT WAS UNRUPTURED AND SACCULAR. THE MAX DIAMETER WAS 9MM AND THE NECK WAS 4MM. BLOOD FLOW WAS NORMAL. THE ANATOMY WAS REPORTED TO BE NORMAL IN TORTUOSITY. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE AXIUM COIL WAS PLACED AND DETACHMENT WAS ATTEMPTED THREE TIMES USING AN INSTANT DETACHER. DETACHMENT WAS UNSUCCESSFUL. MANUAL DETACHMENT WAS ATTEMPTED TWO TIMES ALSO WITHOUT SUCCESS. THE COIL WAS REMOVED. A NEW COIL WAS USED TO TREAT THE PATIENT. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8501913 ↗

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