Axium PrimeTM APB-5-10-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536032033), received between Jun 10, 2020 and Jan 23, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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.

• MalfunctionJan 23, 2023Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THE AXIUM WAS NOT CONFIRMED TO BE RELEASING IN THE CATHETER. IT ONLY PRESENTED RESISTANCE AND DID NOT PROGRESS INSIDE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224740 ↗
• MalfunctionJun 10, 2020Separation Failure; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Separation Failure; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WOULD NOT DETACH. IT WAS REPORTED THAT PHYSICIAN TRIED TO MANY TIMES TO DETACH THE COIL, INCLUDING MANUALLY. THE COIL WAS WITHDRAWN AND WAS FOUND TO BE BROKEN AND STUCK IN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED TOGETHER WITH THE COIL. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY SEGMENT C4. THE MAX DIAMETER WAS 5 MM, AND THE NECK DIAMETER WAS 2 MM. THE PATIENT¿S BLOOD FLOW AND TORTUOSITY WERE NORMAL. ANCILLARY DEVICES INCLUDE AN ECHELON MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10140878 ↗

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