Axium PrimeTM APB-4-10-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536032002), received between Apr 12, 2020 and Mar 26, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 14MM AND THE NECK DIAMETER WAS 4MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED CONTINUOUSLY DURING THE PROCEDURE. WHEN THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE COIL, IT DETACHED BY ITSELF. THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY. THE PHYSICIAN HAD NOT REPOSITIONED OR ATTEMPTED TO DETACH THE COIL. A SNARE WAS USED TO REMOVE THE COIL FROM THE PATIENT'S VESSEL. ANOTHER MANUFACTURER'S PRODUCT WHEN THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13918905 ↗
• MalfunctionNov 16, 2021Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS BACK FLUSHED AND TAKEN IN THE MICROCATHETER TO THE ANEURYSM. AS THE COIL WAS PLACED AND ATTEMPTED TO BE REPOSITIONED, THE COIL WAS HERNIATING IN THE PATIENT ARTERY AND THEY FOUND THE COIL TO BE STIFF AND THERE WAS FRICTION. THE COIL WAS ATTEMPTED TO BE PULLED BACK, HOWEVER, IT WAS STUCK AND THE COIL GOT STRETCHED AND DETACHED. THE COIL WAS REMOVED USING A SNARE. A CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE. THE PHYSICIAN REPOSITIONED THE COIL 2-3 TIMES. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE DACA WITH A MAX DIAMETER OF 4.2MM AND A 1.7MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. ANCILLARY DEVICES INCLUDE A COOK SHUTTLE GUIDE CATHETER, A NEURON MICROCATHETER, A HEADWA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12823444 ↗
• MalfunctionApr 12, 2020Unintended Movement; Unintended Movement

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9951994 ↗

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