AxiumTM QC-1.5-1-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536017153), received between Mar 8, 2019 and Apr 27, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 27, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE PUSHED OUT OF THE DISTAL END AFTER BEING PUSHED INTO THE MICROCATHETER. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER OR COIL. A REPLACEMENT COIL 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 FUSIFORM, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 6 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER USED IN THE EVENT WAS AN ECHELON-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735682 ↗
• InjuryMar 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THE LAST COIL PREMATURELY DETACHED AS THE PHYSICIAN WAS ATTEMPTING TO DEPLOY IT WHICH RESULTED IN THE COIL BEING PARTIALLY DEPLOYED IN THE ANEURYSM AND HALF OF THE COIL WAS OUTSIDE THE ANEURYSM UNSECURE IN THE PARENT VESSEL. A MICRO SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE IMPLANT COIL FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 4MM X 2MM LOCATED IN THE MCA ¿ M2 BIFURCATION. THE PATIENT¿S VASCULATURE WAS MODERATE IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL. THE PUSHWIRE WAS NOT BENT OR BROKEN AND WILL NOT RETURNED AS IT WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405737 ↗