Axium Detachable Coil System QC-6-20-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536037434), received between Apr 11, 2024 and Sep 6, 2024 — classified as 3 malfunctions.

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

• MalfunctionSep 6, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE IN THE ECHELON CATHETER AND WAS FOUND STRETCHED. THE PATIENT WAS UNDERGOING ANEURYSM EMBOLIZATION FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMALAND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE EMBOLIZATION OF THE POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE MICROCATHETER WAS SUCCESSFULLY PLACED IN PLACE AND THE QC-6-20-HELIX WAS INSERTED. DURING THE INSERTION PROCESS, IT WAS FOUND THAT THE SPRING COIL WAS STRETCHED. DURING THE WITHDRAWAL PROCESS, THE MICROCATHETER WAS VERY ASTRINGENT AND THE SPRING COIL SYSTEM COULD NOT BE WITHDRAWN, SO THE ENTIRE SYSTEM WAS WITHDRAWN AS A WHOLE. AFTER REPLACED WITH THE NEW MICROCATHETER AND SPRING COIL, THE FILLING WAS SUCCESSFULLY PERFORMED. IT WAS REPORTED THERE WAS CATHETER RESISTANCE THAT OCCURRED IN THE MIDDLE SECTION. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE MIDDLE OF THE CATHETER. THERE WAS COIL DAMAGE OBSERVED ON THE IMPLANT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157577 ↗
• MalfunctionJul 26, 2024Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS WERE FOUND STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM SPRING COIL WAS STRETCHED. AFTER REPLACEMENT, IT WAS SUCCESSFULLY IMPLANTED. 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 RECEIVED THAT THE CAUSE OF THE COIL STRETCH WAS DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE CAUSE WAS UNDETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19842753 ↗
• MalfunctionApr 11, 2024Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087824 ↗

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