Axium QC-22-50-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00836462010536), received between Mar 26, 2019 and Oct 12, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 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.

• MalfunctionOct 12, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE ENTIRE BROKEN AXIUM COIL WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919217 ↗
• MalfunctionSep 11, 2019Component or Accessory Incompatibility; Component or Accessory Incompatibility

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL "WAS NOT VISIBLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8992827 ↗
• MalfunctionSep 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED AREPORT THAT AN AXIUM COIL UNINTENTIONALLY DETACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8992821 ↗
• MalfunctionMar 26, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE PHYSICIAN COULD NOT DETACH THE IMPLANT COIL WITH THE INSTANT DETACHER AFTER THE COIL WAS INSERTED INTO THE ANEURYSM. ANOTHER INSTANT DETACHER (WITH DIFFERENT LOT) WAS USED AND THE IMPLANT COIL STILL COULD NOT BE DETACHED. THERE WAS ALSO AN ATTEMPT TO DETACH THE COIL USING THE MANUAL METHOD (BREAKING OF THE HYPOTUBE, AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE) BUT THE COIL STILL DID NOT DETACH. IN THE END, PRIME COILS WERE USED AND THEY WERE ABLE TO BE SUCCESSFULLY DETACHED. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF CEREBRAL ANEURYSM MEASURING 24MM. THE PATIENT¿S VASCULATURE WAS MEDIUM IN TORTUOSITY. ANCILLARY DEVICES: PRIME COILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454532 ↗

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