Axium QC-6-15-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836462010383), received between Sep 2, 2020 and Sep 2, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionSep 2, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE WITH TWO AXIUM COILS. IT WAS REPORTED THAT THE MICROCATHETER WAS MOVED TO THE ANEURYSM LOCATION AND THE DOCTOR STARTED PASSING A QC 6-20 AXIUM COIL THROUGH THE SHEATH INTO THE MICROCATHETER. HIGH RESISTANCE WAS FELT BY THE OPERATOR, AND IT WAS NOTICED THAT THE THERE WAS A KINK ON THE PROXIMAL PARTOF THE PUSHER WIRE. THE DOCTOR TRIED TO RESHEATH AND PUSH AGAIN, BUT IT WAS NOT ABLE TO BE ADVANCED DUE TO THE PUSHER WIRE KINK. LATER THE DOCTOR TOOK A QC 6-15 AXIUM COIL AND WAS ABLE SMOOTHLY PASS THROUGH THE MICROCATHETER, BUT WHILE DEPLOYING IT INTO THE ANEURYSM THERE WAS RESISTANCE FELT WHEN THE COIL WAS PARTIALLY DEPLOYED. THE COIL WAS TAKEN BACK COMPLETELY INTO THE MICROCATHETER AND THE DOCTOR TRIED DEPLOYING AGAIN, BUT RESISTANCE WAS FELT AGAIN. THE DOCTOR WAS ABLE TO SUCCESSFULLY DEPLOY OTHER COILS USING THE SAME MICROCATHETER WITHOUT ISSUE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCOR DING TO THEINSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT SUPRACLINOID. THE MAX DIAMETER WAS 6 MM. THE NECK DIAMETER WAS 3.7 M

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10486173 ↗

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