Axium PrimeTM APB-6-20-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536032378), received between Sep 12, 2023 and Sep 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2023Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE 5TH AXIUM COIL WAS TAKEN TO FILL THE INFERIOR SPACE OF THE ANEURYSM WHICH WAS FILLING IN THE ANGIOGRAPHY, IT COULD NOT DETACH. THE AXIUM COIL WAS NOT DETACHED WITH THE INSTANT DETACHER AND MANUAL ALSO TRIED BUT THAT WAS UNSUCCESSFUL. THE PHYSICIAN TOOK OUT THE AXIUM COIL AND ANOTHER COIL WAS DEPLOYED. THE PHYSICIAN ATTEMPTED TO DETACH THE AXIUM USING THE INSTANT DETACHER 3 TIMES WITH ONLY 1 INSTANT DETACHER. THERE WAS A 1 MANUAL ATTEMPT BY USING THE HYPOTUBE BUT IT GOT BROKEN. THE AXIUM AND ANY ACCESSORIES 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 A SACCULAR, RUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 16MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A NEURONMAX SHEATH, NEURON GUIDE CATHETER, ECHELON 10 MICROCATHETER, AND A TRAXCESS GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733772 ↗

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-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
• 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