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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536034068), received between Aug 16, 2021 and Mar 1, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT THE AXIUM COIL'S WIRE WAS BROKEN SO THE DOCTOR COULDN'T SELECT THE COIL IN LESION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NEW INFORMATION WAS RECEIVED. THE PUSHWIRE WAS THE PART OF THE COIL WITH THE DAMAGE. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16463694 ↗
• MalfunctionFeb 23, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL'S WIRE WAS BROKEN SO THE DOCTOR FAILED TO SELECT ON TARGET LESION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM.  IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS UNKNOWN AND VESSEL TORTUOSITY WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED THAT ACTIONS TAKEN TO RESOLVE THE PUSHWIRE DAMAGE WAS THEY CHANGED TO A NEW DEVICE WHEN THE PROBLEM OCCURRED. IT WAS CLARIFIED THAT "THE DOCTOR FAILED TO SELECT ON TARGET LESION" THAT THE DOCTOR COULDN'T CONTROL THE COIL BECAUSE OF THE PUSHWIRE. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432196 ↗
• MalfunctionDec 1, 2022Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL ADVANCED AND FORMED AS NORMAL. PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT ONLY FROM TRYING TO MANUALLY DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894231 ↗
• MalfunctionAug 16, 2021Difficult or Delayed Positioning; Stretched; Detachment of Device or Device Component; Unintended Movement; Difficult or Delayed Positioning; Stretched; Detachment of Device or Device Component; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM FRAMING COIL THAT HAD DIFFICULTY WITH POSITIONING AND BLOCKED THE PARENT VESSEL AND THEN DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED AMORPHOUS ANEURYSM OF THE RIGHT ANTERIOR COMMUNICATING ARTERY. THE ANEURYSM MAX DIAMETER WAS 4.02MM AND THE NECK DIAMETER WAS 2.89MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE MICROCATHETER WAS IN PLACE AND THE AXIUM FRAMING COIL WAS SELECTED TO FORM THE HOOP. DURING HOOP FORMATION, THE COIL WAS ADJUSTED SLIGHTLY AND HOOP FORMATION WAS CONSIDERED COMPLETE. HOWEVER, ANGIOGRAPHY REVEALED BLOOD FLOW OF ONE OF THE A2 VESSELS WAS BLOCKED SO ADJUSTMENT OF THE COIL WAS ATTEMPTED AND THE COIL WAS FOUND STRETCHED AND DETACHED. IT WAS NOTED THAT THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OF THE COIL. THERE WAS NO DAMAGE TO THE PUSHWIRE. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE AXIUM FRAMING COIL AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COIL EMBOLIZATION PROCEDURE CONTINUED. THOUGH THERE WAS AFFECTE

  Patient problems: Obstruction/Occlusion

  MAUDE report 12324891 ↗