Axium PrimeTM APB-6-15-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536032064), received between Sep 2, 2022 and Sep 2, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjurySep 2, 2022Stretched; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED AND WAS STRETCHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5.8MM, AND THE NECK DIAMETER WAS 4.6MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT COIL WAS ACCIDENTALLY DETACHED DURING FILLING. PART OF THE COIL WAS IN THE ANEURYSM, AND THE REST WAS IN THE PARENT ARTERY. WHEN THE SURGEON CONTINUED TO PUSH, IT STRETCHED. THE SURGEON USED THREE STENTS TO PRESS THE COIL BODY AGAINST THE VESSEL WALL. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. IT WAS NOTED THAT THE PUSHWIRE WAS BENT OR BROKEN, WHICH WAS NOT ON PURPOSE, AND THERE HAD BEEN FRICTION/DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, NO DETACHMENT ATTEMPTS HAD BEEN MADE, AND THE PUSHER WAS NOT ROTATED. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR SYMPTOMS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Foreign Body In Patient

  MAUDE report 15349721 ↗

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