Axium Prime Detachable Coil System APB-4-10-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536038233), received between May 26, 2023 and May 22, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT REGARDING AXIUM COIL NON-DETACHMENT. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A POSTERIOR COMMUNICATING ARTERY (PCOM) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 1.2MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS DELIVERED SUCCESSFULLY THROUGH THE MICROCATHETER TO THE ANEURYSM AND POSITIONED AS DESIRED. DEPLOYMENT WAS INITIATED AND SEEMED TO BE SUCCESSFUL WITH THE INSTANT DETACHER (ID) UNDER IMAGING. HOWEVER, WHEN THE COIL PUSHER WAS BEING REMOVED, IT WAS EVIDENT THAT THE COIL HAD NOT BE DETACHED. THE COIL WAS REPOSITIONED AND AN ATTEMPT WAS MADE TO DETACH THE COIL MANUALLY WITH THE HYPOTUBE, BUT AGAIN, THE COIL FAILED TO DETACH. THE COIL WAS REMOVED AND REPLACED BUT THE SAME ISSUE OCCURRED. THE SAME MANEUVERS WERE ATTEMPTS BUT STILL THE REPLACEMENT COIL DID NOT DETACH. IT WAS NOTED THAT SEVERAL UNSUCCESSFUL DETACHMENT ATTEMPTS WERE MADE WITH THE ID AND WITH A SECOND ID, BUT WITHOUT SUCCESS. ONE UNSUCCESSFUL ATTEMPT WAS MADE FOR MANUAL DETACHMENT WITH EACH COIL. THREE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072162 ↗
• MalfunctionMay 22, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL RELEASE MECHANISMS ARE NOT BEING REPORTED FOR THE STUDY. THERE IS NO ISSUE WITH THE PROGRESS OF THE DEVICES THROUGH THE SYSTEM. NO DAMAGE IS OBSERVED IN THE PUSHER. THE ERROR OCCURRED WITH TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072047 ↗
• MalfunctionFeb 29, 2024Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED. THERE WERE NO DETACHMENT ATTEMPTS WITH THE INSTANT DETACHER OR MANUAL METHOD MADE. THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE. THE AXIUM COIL WAS REMOVED FROM THE PATIENT. THE CATHETER MODEL WAS AN ECHELON10. A TOTAL OF 1 SPRING COIL WAS IMPLANTED BEFORE AND AFTER THE MALFUNCTIONED COIL. THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED DUE TO COIL IMPLANTATION AT AN UNINTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807242 ↗
• MalfunctionJun 6, 2023Separation Failure; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Separation Failure; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL DETACHED PREMATURELY IN THE DISTAL END OF THE MICROCATHETER BEFORE IT WAS COMPLETELY DEPLOYED. THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED CONTINUOUSLY DURING THE PROCEDURE. THERE WAS FRICTION DURING DELIVERY OF THE COIL. IT WAS NOTED THAT THE PHYSICIAN HAD REPOSITIONED THE COIL TWICE AND HAD ATTEMPTED TWICE TO DETACH THE COIL WITH THE INSTANT DETACHER (ID); NO ATTEMPTS HAD BEEN MADE AT MANUAL DETACHMENT. SINCE THE COIL DETACHED WITHIN THE MICROCATHETER, THE WHOLE SYSTEM WAS CAREFULLY REMOVED TOGETHER FROM THE PATIENT'S BODY. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED POSTERIOR COMMUNICATING SEGMENT (PCOM) SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5.5MM AND THE NECK DIAMETER WAS 2.1MM. BLOOD FLOW WAS HIGH. VESSEL TORTUOSITY WAS SEVERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071753 ↗
• MalfunctionMay 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY  WITH A MAX DIAMETER OF 3.8 MM AND A 2.7 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT IN THE EMERGENCY TREATMENT OF RUPTURED ANTERIOR COMMUNICATING ARTERY SACCULAR ANEURYSM, AFTER THE MICROCATHETER ECHELON 10 WASIN PLACE, THE APB-4-10-3D-SS WAS FILLED. WHEN FILLING IN ABOUT 3/4, IT WAS READY TO BE PULLED BACK FOR ADJUSTMENT, AND IT WAS FOUND THAT THE SPRING COIL DETACHED IN THE MICROCATHETER AND COULD NOT BE PULLED BACK. THEREFORE, PUSHED THE REMAINING PART OF THE COIL TO ABOUT 3MM FROM THE DISTAL END OF THE MICROCATHETER WITH THE PUSH ROD, AND THEN USED THE SYNCHRO 14 MICRO GUIDE WIRE TO PUSH THE COIL COMPLETELY OUT OF THE MICROCATHETER. IT WAS REPORTED COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE COIL REMAINS IN THE PATIENT. THE COIL WAS IMPLANTED IN THE INTENDED LOCATION. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010515 ↗

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