Axium QC-7-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00836462010178), received between May 5, 2019 and Oct 3, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionOct 3, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS NOT DETACHED AT THE ANEURYSM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (RICA) WITH A MAX DIAMETER OF 8.2MM AND A 2.67MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE COIL WAS NOT DETACHED AT THE ANEURYSM. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER THREE TIMES. THE PHYSICIAN DID NOT ATTEMPT TO DETACH WITH A DIFFERENT INSTANT DETACHER. THE MANUAL METHOD OF DETACHMENT WAS ATTEMPTED ONCE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THE EVENT. ANCILLARY DEVICES INCLUDE A NEURON MAX GUIDE CATHETER, A NEURON 6F 070 MICROCATHETER, A EXCELSIOR GUIDEWIRE, AND A TAXCESS 14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566676 ↗
• MalfunctionMar 24, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THE FIRST AXIUM COIL WOULD NOT DETACH WITH AN INSTANT DETACHER OR USING MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE) DURING THE COILING TREATMENT OF ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DETACH THE COIL 4-5 TIMES WITH USING INSTANT DETACHER AND 2 TIMES ATTEMPTED WITH MANUAL DETACHMENT. THE COIL FINALLY DETACHED INSIDE THE MEDTRONIC MICROCATHETER. IT WAS ALSO REPORTED THAT SECOND AXIUM COIL DETACHED PREMATURELY INSIDE THE MEDTRONIC MICROCATHETER. THIS SECOND COIL WAS NOT REPOSITIONED AND NOT ATTEMPTED TO BE DETACHED. THE PATIENT UNDERWENT COILIN TREATMENT FOR A SMALL UNRUPTURED SACCULAR ANEURYSM LOCATED IN INTERNAL CAROTID ARTERY (ICA). A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE VESSEL ANATOMY AND BLOOD FLOW WERE BOTH NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9876087 ↗
• MalfunctionMay 5, 2019Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL GAVE EXTREME RESISTANCE WHILE PUSHING OUT THE SLEEVE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS RETURNED TO MEDTRONIC FOR EVALUATION AND FOUND TO BE PREMATURELY DETACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8580898 ↗

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