AxiumTM APB-6-20-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536013032), received between Dec 12, 2018 and Jun 19, 2024 — classified as 4 malfunctions.

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

• MalfunctionJun 19, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE IN THE ECHELON CATHETER AND WAS FOUND KINKED/DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 7.83 MM AND A 4.31 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE FIRST COILS WERE SUCCESSFUL IMPLANTED AXIUM 3D 6-20. THEN THE PHYSICIAN INSERTED THE SECOND COILS AXIUM HELIX 6-20, BUT IT WAS STUCK 5CM FROM THE PROXIMAL MICROCATHETER. IT WAS REPORTED THE COIL ENCOUNTERED RESISTANCE/STUCK IN PROXIMAL SECTION OF THE MICROCATHETER. THERE WAS NO CATHETER DAMAGE OBSERVED. THE COIL WAS OBSERVED TO BE KINKED/DAMAGED. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGED/STRETCHED LOCATION WAS ON THE IMPLANT COIL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE PHYSICIAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571296 ↗
• MalfunctionJun 7, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT 2 AXIUM COILS WERE BROKEN. THE COIL WAS BROKEN; THE SIZE WAS CHANGED ON THE NEXT ONE, BUT IT WAS ALSO BROKEN. AFTER THAT, IT WAS REPLACED WITH A COIL FROM OTHER COMPANY AND WAS ABLE TO FINISH WITHOUT ANY TROUBLE. ON A SIDE NOTE, THE COIL OF THE OTHER COMPANY COULD BE PLACED PROPERLY WITHOUT GETTING BROKEN. THE COIL EXTENSION WAS BROKEN. THERE WAS NO RESISTANCE DURING PREPARATION OR USE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COILS WERE NOT REPOSITIONED. THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR ANEURYSM. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14627866 ↗
• MalfunctionJul 8, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL PARTIALLY DETACHED / BROKE WITHIN THE CATHETER. AT THE LATEST COIL WAS COIL NUMBER 42. WHEN MANIPULATION IN THE FISTULA A SHORT PART OF THE COIL BROKE. A PART THAT DETACHED STAYED IN THE PATIENT WITHOUT ANY PROBLEMS, BETWEEN THE OTHER 41 COILS. THE OTHER PART WAS STAYED WITHIN THE CATHETER AND IT WAS SAFELY REMOVED. THIS EVENT WAS REPORTED TO HAVE OCCURRED DURING THE TREATMENT OF VERTEBRAL FISTULA. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE. THE PUSHWIRE WAS NOT NOTED TO HAVE BEEN DAMAGED. THERE WAS NO FRICTION OR DIFFICULTY WHEN DELIVERING THE COIL. THE COIL WAS NOT REPOSITIONED AND WAS NOT ATTEMPTED TO BE DETACHED. THE PUSHWIRE WAS NOT ROTATED. A CONTINUOUS FLUSH WAS USED. THE BLOOD FLOW WAS NORMAL. THE ANATOMY WAS SEVERE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8768163 ↗
• MalfunctionDec 12, 2018Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  THERE WAS NO DAMAGE TO THE PROXIMAL END OF THE PUSHWIRE DURING USE OR AFTER IT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 TIMES. A SECONDARY METHOD WAS ALSO ATTEMPTED TO DETACH THE COIL, WITH NO FORCE REQUIRED TO PULL THE RELEASE WIRE NOTED. THE PHYSICIAN ATTEMPTED TO BREAK THE PUSHWIRE 2 TIMES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8157195 ↗

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