Axium PrimeTM APB-4-8-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536032309), received between Nov 28, 2020 and Jun 9, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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.

• MalfunctionJun 9, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  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 AFTER SEVERAL ATTEMPTS, IT WAS FOUND THAT THE SPRING COIL WAS "BROKEN" IN THE MICROCATHETER AFTER IT WAS WITHDRAWN.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 14643555 ↗
• MalfunctionNov 28, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10916016 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab