Axium Detachable Coil System QC-20-50-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536038011), received between Dec 20, 2021 and Mar 26, 2025 — classified as 4 malfunctions.

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

• MalfunctionMar 26, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE BARE AXIUM 3D COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE PUSHING THE COIL THROUGH THE MICROCATHETER. THE COIL BECAME STUCK IN THE MIDDLE OF THE CATHETER AND WAS SUBSEQUENTLY REMOVED. UPON REMOVAL, THE COIL APPEARED FULLY STRETCHED AND RESEMBLED A THIN STRAND. THE COIL WAS REPLACED WITH ANOTHER COIL, WHICH WAS SUCCESSFULLY DEPLOYED USING THE SAME MICROCATHETER. THE COIL WAS NOTED TO BE DAMAGED AT THE IMPLANT COIL LOCATION. THE CATHETER WAS NOT DAMAGED. ADDITIONAL INFORMATION RECEIVED REPORTED NO PATIENT SYMPTOMS. THE CAUSE OF THE RESISTANCE/STRETCH WAS NOT DETERMINED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. ANCILLARY DEVICES USED: EXCELSIOR SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701905 ↗
• MalfunctionOct 24, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL FAILED TO DETACH. DURING THE SURGERY, THE SPRING COIL COULD NOT BE DETACHED NORMALLY. TWO ATTEMPTS WERE MADE TO DETACH WITH THE INSTANT DETACHER. TWO ATTEMPTS WERE MADE WITH THE SECOND DETACHER. ONE MANUAL ATTEMPTS WAS MADE TO DETACH WITH THE HYPOTUBE. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 23MM AND THE NECK DIAMETER WAS 16MM. THE PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663780 ↗
• MalfunctionFeb 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING A PROCEDURE AN AXIUM COIL WAS STRETCHED AND ANOTHER AXIUM COIL DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR LEFT CAVERNOUS SINUS ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 20MM AND THE NECK DIAMETER WAS 12MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER THE AXIUM COIL WAS DELIVERED, IT WAS OBSERVED TO BE STRETCHED. THE COIL WAS REMOVED AND REPLACED. DURING THE SAME PROCEDURE, ANOTHER AXIUM COIL DETACHED PREMATURELY DURING DELIVERY IN THE MICROCATHETER. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. IT WAS NOTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13607824 ↗
• MalfunctionDec 20, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ISSUES ENCOUNTERED DURING THE PROCEDURE PRIOR TO NON-DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043326 ↗

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