Axium PrimeTM FC-9-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536034327), received between Sep 22, 2020 and Mar 28, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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.

• MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY. THE COIL HAS BEEN DETACHMENT IN ADVANCE. THE PROCEDURE IS COMPLETED BY PUSHING THE COIL WITH A WIRE. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICAIN REPOSITIONED THE COIL 2 TIMES. THE PHYSICIAN DID NOT ROTATED GTHE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PERPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT PARACLINOID. THE MAX DIAMETER WAS 10MM AND THE NECK DIAMETER WAS 4MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTOUSITY WAS MODERATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996433 ↗
• MalfunctionSep 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE FIRST COIL WAS DELIVERED TO THE TARGET LESION, BUT IT WAS NOTICED THE COIL STRETCHED IN THE HUB. A SECOND COIL WAS DELIVERED, BUT IT PREMATURELY DETACHED IN THE CATHETER. A THIRD COIL WAS THEN USED, BUT IT BECAME STUCK AT THE CATHETER HUB. IT WAS REPORTED TO BE UNKNOWN IF THERE WAS ANY DAMAGE TO THE COILS OR CATHETER AND UNKNOWN IF THE COIL PUSHED OUT OF THE SHEATH SMOOTHLY. 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. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT WITH THE EVENT. ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10570159 ↗