Axium PrimeTM FC-4-8-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536034129), received between Oct 19, 2020 and Apr 5, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM FRAMING COIL PREMATURELY DETACHED INSIDE A MICROCATHETER. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT 6X6 SUPRACLINOID. THE MAX DIAMETER WAS 6.1MM AND THE NECK DIAMETER WAS 3.75MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  WHILE ADVANCING, A FC-4-8-3D COIL DETACHED PREMATURELY INSIDE THE SL10 MICRO CATHETER. THE COIL WAS DEPLOYED HALFWAY INTO THE ANEURYSM AND HALF WAS STILL INSIDE THE SL10 MICRO CATHETER. MULTIPLE ATTEMPTS AT RETRIEVING THE MALFUNCTIONED COIL WAS PERFORMED UNTIL SUCCESSFUL RETRIEVAL WAS ACHIEVED WITH MEDTRONIC 6X40 SOLITAIRE DEVICE. SURGICAL INTERVENTION WAS NOT REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION OR ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO SYMPTOMS WERE REPORTED. ANCILLARY DEVICES: 8FR TERUMP SHEATH, PENUMBRA NEURON MAX .088 GUIDECATHETER, STRYKER SL10 MICORCATHETER, MEDTRONIC M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017966 ↗
• MalfunctionJan 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PRE-MATURELY DETACHED. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13186171 ↗
• MalfunctionOct 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROCEDURE WAS COMPLETED AFTER THE COIL WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10701831 ↗