Axium PrimeTM APB-2.5-6-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536031913), received between Nov 18, 2020 and Nov 1, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO COIL NON-DETACHMENT THERE WERE NO ISSUE ENCOUNTERED. THERE WAS NO PUSHWIRE DA MAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728568 ↗
• MalfunctionJun 8, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION AN AXIUM COIL THAT FAILED TO DETACH DURING A PROCEDURE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF A M2 SEGMENT. PATIENT VESSEL TORTUOSITY WAS VERY SEVERE AND THE PHYSICIAN REPORTED IT MADE THE CASE DIFFICULT. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED CONTINUOUSLY DURING THE PROCEDURE. THE MICROCATHETER WAS PLACED AT THE INTENDED LOCATION IN THE M2. THE AXIUM COIL (MODEL: APB-2.5-6-3D-ES, LOT: B093781) WAS DELIVERED TO THE ANEURYSM BUT COULD NOT BE DETACHED. ABOUT 10 ATTEMPTS WERE MADE TO DETACH THE COIL WITH THE INSTANT DETACHER (ID) WITHOUT SUCCESS. A SECOND ID WAS TRIED, AGAIN ABOUT 10 TIMES, WITHOUT SUCCESS. IT WAS NOTED THERE WAS NOTHING WRONG WITH EITHER ID. MANUAL DETACHMENT WAS ALSO ATTEMPTED 5 TIMES WITHOUT SUCCESS. FINALLY THE COIL WAS REMOVED AND REPLACED. THERE WAS NO DAMAGE NOTED TO THE CATHETER. THIS COIL REPLACED. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960106 ↗
• MalfunctionJun 7, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11950255 ↗
• MalfunctionJun 2, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT, AND NO DAMAGE WAS OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925342 ↗
• MalfunctionDec 8, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN ATTEMPTED TO DETACH 2 OR 3 TIMES USING AN INSTANT DETACHER AND THE MANUAL DETACHMENT METHOD, BUT THOUGHT IT WOULDN'T WORK BECAUSE THE COIL WAS BROKEN. PRIOR TO NON-DETACHMENT THE COIL WAS BROKEN IN THE MIDDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10969154 ↗
• MalfunctionDec 7, 2020Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  NO INVESTIGATION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10959193 ↗
• MalfunctionNov 18, 2020Separation Failure; Separation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10864477 ↗