Axium QC-5-15-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462010376), received between Jan 28, 2019 and May 17, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2021Stretched; Detachment of Device or Device Component; Material Deformation; Stretched; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE GUIDE CATHETER AND MICROCATHETER WERE IN PLACE. THE AXIUM COIL BECAME STRETCHED/DAMAGED ON THE PROXIMAL SEGMENT OF THE PUSHWIRE AND WAS UNABLE TO BE IMPLANTED. THE COIL HAD BECOME DETACHED DURING USE. IT WAS NOTED THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A MAX DIAMETER OF 3.7 MM AND A 2.9 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11837422 ↗
• MalfunctionJan 28, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING A COILING PROCEDURE, THE COIL FAILED TO DETACH WITH AN INSTANT DETACHER AND MANUAL DETACHMENT (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE). THE COIL WAS POSITIONED INTO THE ANEURYSM WHEN IT FAILED TO DETACH. TWO DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER AND THEN MANUAL METHOD WAS ATTEMPTED, BUT THE COIL DID NOT DETACH. THE COIL WAS REMOVED FROM WITHIN THE CATHETER. SUBSEQUENT COIL WAS USED TO TREAT THE PATIENT. NO PATIENT INJURY OCCURRED. THIS EVENT OCCURRED DURING THE TREATMENT FOR A SMALL RUPTURED SACCULAR ANEURYSM LOCATED IN LEFT POSTERIOR COMMUNICATING ARTERY, MEASURING 5MMX3MM. THE VESSEL ANATOMY WAS NORMAL. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8282025 ↗

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