Axium Prime Detachable Coil System APB-6-15-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536038295), received between Jun 28, 2024 and Sep 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Separation Failure; Physical Resistance/Sticking

  Medtronic received a report that an Axium coil encountered resistance in the Echelon catheter and failed to deploy. The Echelon catheter was also found kinked. The patient was undergoing aneurysm embolization for treatment of a saccular, unruptured aneurysm located in the C6 segment with a max diameter of 3.69 mm and a 3.45 mm neck diameter. The accessed vessel was the femoral artery with a diameter of 6.5 mm. It was noted the patient's blood flow was normal, and vessel tortuosity was normal. It was reported that during the aneurysm procedure, when using the Echelon to deliver the Axium coil, the resistance was obvious during advancement. Upon continuing to push, after it was advanced into position with difficulty, the coil could not be deployed normally. The operator suspected an Echelon issue. After removing the Echelon, it was found that the tip end had kinked and could not be used. After replacing with a new Echelon, coil advancement was smooth; however, after reaching the target position, it still could not be detached. Subsequently, a new coil was used instead; advancement was smooth and all were successfully deployed. The reported device and any accessory devices were prepar

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915621 ↗
• MalfunctionSep 24, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892345 ↗
• MalfunctionAug 31, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525667 ↗
• MalfunctionJul 23, 2025Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE AB STENT FAILED TO DETACH. THE PATIENT WAS UNDERGOING TREATMENT OF A SACCULAR, UNRUPTURED LEFT INTERNAL CAROTID ANTERIOR COMMUNICATING SEGMENT ANEURYSM WITH UNKNOWN DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SOLITAIRE AB STENT WAS BEING USED FOR ANEURYSM COILING WITH A REMODELING TECHNIQUE. DURING THE DETACHMENT PHASE, THE DEVICE FAILED TO RELEASE. TROUBLESHOOTING STEPS INCLUDED BATTERY REPLACEMENT, CABLE CHANGES, AND REPLACEMENT OF THE DETACHMENT BOX, BUT ALL ATTEMPTS WERE UNSUCCESSFUL. THE SETUP FOLLOWED STANDARD PROTOCOL: THE RED CABLE WAS CONNECTED TO THE PUSHER WIRE, THE BLACK CABLE TO THE NEEDLE, AND THE PUSHWIRE WAS PLACED ON A CLEAN, DRY SURFACE.AS DETACHMENT COULD NOT BE ACHIEVED AND REMOVING THE STENT WOULD HAVE LED TO COIL DISPLACEMENT, THE PHYSICIAN DECIDED TO CUT THE PUSHER WIRE, LEAVING THE STENT IN PLACE. NO ADVERSE EFFECTS WERE REPORTED, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT, DURING A FOLLOW-UP MEDICAL VISIT AFTER THE PROCEDURE, REPORTED EXPERIENCING NECK PAIN WHEN TURNING THEIR HEAD, DESCRIBING IT AS A PULLING SEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580374 ↗
• MalfunctionJan 9, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE FIRST SPRING COIL 6-15 ENTERED THE MICROCATHETER, IT COULD NOT BE PUSHED OR WITHDRAWN. THE WHOLE WAS WITHDRAWN FROM THE BODY. THE MICROCATHETER AND THE SPRING COIL BODY WERE FOUND TO BE DAMAGED. IT  WAS REPLACED WITH A NEW MICROCATHETER AND THE SPRING COIL WAS DELIVERED. WHEN DELIVERING THE 2.5-4 SPRING COIL, THE RESISTANCE WAS FOUND TO BE LARGER, AND THE SPRING COIL WAS WITHDRAWN FROM THE BODY AND THE COIL BODY WAS FOUND TO BE DAMAGED. RESISTANCE HAD BEEN IN THE MIDDLE SEGMENT OF THE CATHETER. THERE WERE NO SYMPTOMS REPORTED. THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS BEING TREATED FOR A SACCULAR, UNRUPTURED ANEURYSM IN C4 WITH A MAX DIAMETER OF 6MM AND A NECK DIAMETER OF 2MM. BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 10MM DIAMETER. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE RESISTANCE/DAMAGE WAS NOT DETERMINED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. BESIDES THE RESISTANCE, THERE WERE NO OTHER ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118887 ↗
• MalfunctionJun 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT BROKE OR DETACHED PREMATURELY. IT WAS REPORTED THAT THE COIL CAME OFF WHEN INSERTED IN THE MICROCATHETER. IT IS UNCLEAR IF THE PHYSICIAN HAD ATTEMPTED COIL DETACHMENT. THERE WAS NO FRICTION OR OTHER DIFFICULTY OBSERVED DURING DELIVERY OF THE COIL. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE COIL WAS REMOVED FROM THE PATIENT; NO ADDITIONAL INTERVENTION WAS REQUIRED. THERE AS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637722 ↗

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