Axium PrimeTM APB-4-12-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536032323), received between Sep 2, 2020 and May 24, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

• MalfunctionMay 24, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS STUCK IN THE PROXIMAL SECTION OF THE CATHETER. THE IMPLANT COIL PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THERE WAS NO COIL DAMAGE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A NAVIEN072 GUIDE CATHETER, SL-10 MICROCATHETER, AND SYNCHRO14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489928 ↗
• InjurySep 2, 2020Stretched; Migration; Stretched; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL MIGRATED, BECAME STUCK ON THE PIPELINE AND STRETCHED RESULTING IN THE COIL BEING LEFT IN THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RECURRENT SACCULAR, RUPTURED ANEURYSM OF THE LEFT, POSTERIOR COMMUNICATING (PCOM) ARTERY WITH A MAX DIAMETER OF 8MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE PLAN IN THE CASE WAS TO LAY A SECOND LAYER OF PIPELINE IN THE INTERNAL CAROTID ARTERY AND THEN APPROACH THE ANEURYSM FROM THE POSTERIOR FLOW AND COIL THE RECAN AND COIL OCCLUDE THE POSTERIOR COMMUNICATING (PCOM) ARTERY. THE PIPELINE DEPLOYMENT WENT WITHOUT ISSUE. THE MICROCATHETER WAS ABLE TO BE DELIVERED AND PLACED JUST OUTSIDE OF THE ANEURYSM. THE AXIUM SOFT COIL WAS DELIVERED, AND IT WAS THOUGHT THE COIL SHOULD HAVE BEEN PROTECTED FROM ENTERING THE ICA BY THE DOUBLE PIPELINES. THE AXIUM COIL SEEMED TO FILL THE ANEURYSM, BUT THEN MIGRATED PAST THE PIPELINE AND INTO THE MIDDLE CEREBRAL ARTERY (MCA). IT WAS NOTED NO REAL FORCE WAS REQUIRED. DYNA CT APPEARED TO SHOW THE COIL WENT THROUGH THE PIPELINE, AND WAS FLOATING WITHIN THE STENT AND OUT INTO

  Patient problems: Device Embedded In Tissue or Plaque; Dysphasia; Encephalopathy; Hemorrhage, Subarachnoid; Muscle Weakness/Atrophy; Vascular Dissection

  MAUDE report 10486439 ↗

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