Axium Detachable Coil System QC-3-6-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536037366), received between Jan 14, 2023 and Jul 20, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionJul 20, 2026Difficult or Delayed Positioning; Stretched; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882107 ↗
• MalfunctionMay 15, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL COULD NOT BE DETACHED DURING DELIVERY. IT WORKED NORMALLY AFTER REPLACING THE SPRING COIL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 5.2MM AND A 4.1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A COOK 6 SHEATH, 5F NAVIEN GUIDE CATHETER, ECHELON MICROCATHETER, AND SYNCHRO2 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319170 ↗
• MalfunctionApr 3, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS WERE FOUND STRETCHED AND ANOTHER TWO AXIUM COILS WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AXIUM COIL (LOT #226008758 AND 226008758) WAS STRETCHED AND SUCCESSFULLY IMPLANTED AFTER REPLACEMENT. IT WAS REPORTED FOR THE ECHELON CATHETER THE SPRING COIL COULD NOT BE DELIVERED TO THE LESION, BUT THE OPERATION WAS SUCCESSFULLY COMPLETED AFTER REPLACEMENT. IT WAS REPORTED THAT THE AXIUM COIL (LOT # 226235035 AND 225769257) WAS DIFFICULT TO DETACH AND IMPLANTED SMOOTHLY AFTER REPLACEMENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033993 ↗
• MalfunctionJan 14, 2023Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD RESISTANCE IN AN ECHELON10 CATHETER AND IT DETACHED. WHILE INTRODUCING AN AXIUM COIL 3-6-HELIX THROUGH AN ECHELON 10 MICRO-CATHETER RESISTANCE OCCURRED AND WHILE TRYING TI RESHEATH THE COIL INSIDE ITS COVER IT WAS DETACHED. IT WAS STUCK IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS NOT DAMAGED. THE COIL WAS DAMAGED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS OFR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA). THE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 1.5MM. PATEINT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: CHAPERON 6F GUIDE CATHETER, SYNCHRO GUIDEWIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16165453 ↗

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