AxiumTM QC-3-10-3D (UDI 00847536017511)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536017511), received between Mar 11, 2019 and Apr 7, 2020 — 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.

• MalfunctionApr 7, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORTED THAT THERE WAS FRICTION/DIFFICULTY DURING DELIVERY OF THE AXIUM COIL, AND IT BECAME STUCK IN THE MIDDLE SECTION OF THE MICROCATHETER. NO DAMAGE WAS NOTED TO THE CATHETER, BUT THE PUSH WIRE BECAME KINKED/DAMAGED IN THE MIDDLE SEGMENT. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, AND THE PHYSICIAN DID NOT REPOSITION THE COIL. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT. THE MODEL/LOT NUMBERS OF MICROCATHETER ARE UNKNOWN. THE PATIENT¿S AGE, GENDER, WEIGHT AND LESIONS CHARACTERISTICS, AND VESSEL TORTUOSITY IS UNKNOWN. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9933397 ↗
• MalfunctionMar 11, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE PHYSICIAN ATTEMPTED TO DETACH THE IMPLANT COIL WITH THE INSTANT DETACHER BUT WAS UNSUCCESSFUL. AN ATTEMPT TO DETACH WITH THE MANUAL METHOD (BREAKING OF THE HYPOTUBE, AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE) WAS MADE, BUT IT WAS ALSO UNSUCCESSFUL. THE IMPLANT COIL WAS FINALLY REMOVED FROM THE PATIENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED AMORPHOUS ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY (ICA). THE PATIENT¿S DISTAL AND PROXIMAL LANDING ZONE WAS 14MM X 3MM. THE PATIENT¿S VASCULATURE WAS NORMAL IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL. THE PHYSICIAN ATTEMPTED TO DETACH WITH THE INSTANT DETACHER TWICE AND DID NOT TRY A DIFFERENT INSTANT DETACHER. MANUAL METHOD WAS ATTEMPTED 3 TIMES WITHOUT SUCCESS. INSTANT DETACHER WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8409623 ↗

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