Axium PrimeTM APB-2-2-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536031876), received between Jan 15, 2021 and Nov 21, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT COIL COULD NOT BE WITHDRAWN DUE TO ACCIDENTAL DETACH. THE PUSH GUIDE WIRE WAS ABANDONED BY THE HOSPITAL, ONLY THE PACKING BOX WAS GIVEN, AND IT WAS NOT SENT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834091 ↗
• MalfunctionJun 9, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE ONE AXIUM PRIME COIL EXPERIENCED RESISTANCE AND SEPARATED/BROKE/PREMATURELY DETACHED IN THE CATHETER, AND ANOTHER COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3.8MM, AND THE NECK DIAMETER WAS 3.0MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT COIL COULD NOT BE PUSHED OUT OF THE DISTAL PART OF THE MICROCATHETER. AFTER SEVERAL ATTEMPTS, IT WAS FOUND THAT THE SPRING COIL WAS "BROKEN" IN THE MICROCATHETER AFTER IT WAS WITHDRAWN. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PHYSICIAN DID NOT REPOSITION THE COIL, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. ANOTHER COIL IN THE PROCEDURE COULD NOT BE DETACHED. THREE ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND ONE ATTEMPT WAS MADE WITH THE MANUAL METHOD. A SECOND INSTANT DETACHER WAS NOT USED AS THERE WERE NO PROBLEMS WITH IT. AFTER WAITING A FEW MINUTES, IT WAS DECIDED TO WITHDRAW THE COIL; HOWEVER, THE COIL BODY WAS DETACHED IN THE MICROCATHETER DURING THE WITHDRAWAL PROCESS. THE PATIENT DID NOT EXPERIENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644210 ↗
• MalfunctionNov 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS NOT DETACHABLE, SO IT WAS DETACHED INSIDE THE CATHETER WHILE BEING REMOVED. THE COIL WAS REMOVED FROM THE CATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO SURGICAL OR MEDICINAL INTERVENTIONS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL TWICE WITH THE INSTANT DETACHER AND TWICE WITH THE MANUAL METHOD. TWO INSTANT DETACHERS WERE USED. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT ACOM WITH A MAX DIAMETER OF 3MM AND A 1.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE: FUBUKI 8F GUIDE CATHETER AND A HEADWAY 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830486 ↗
• MalfunctionJul 31, 2021Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROBLEM WAS THE DISTAL PUSHER ITSELF. IT WAS DAMAGED (GIVING THE IMPRESSION AS IF THE SPRING WAS ALREADY DETACHED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257058 ↗
• MalfunctionJan 15, 2021Difficult or Delayed Positioning; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO RESISTANCE NOTED AT ANY POINT WHEN THE COIL WAS BEING USED. WHEN THE PHYSICIAN PULLED BACK ON THE COIL TO REPOSITION, IT WAS NOTED THAT THE COIL DID NOT MOVE AND THIS WAS WHEN IT WAS NOTED TO BE DETACHED. THE COIL AND PUSHWIRE REMAINED WITHIN THE CATHETER SO IT WAS UNKNOWN IF THERE WAS ANY DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11179764 ↗