Axium QC-7-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00836462010413), received between Apr 4, 2019 and Apr 2, 2026 — classified as 2 deaths, 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Break; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL BROKE INSIDE THE ECHELON CATHETER THEREFORE IT COULD NOT BE PUSHED. THE COIL WAS STUCK IN THE CATHETER. THE CATHETER WAS DAMAGED. THE COIL WAS DAMAGED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED ANEURYSM. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766902 ↗
• MalfunctionApr 25, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE (STRETCH) THAT WAS FOUND. IT WAS UNKNOWN HOW MANY ATTEMPTS WERE MADE TO DETACH THE COIL USING THE INSTANT DETACHER. MANY MANUAL ATTEMPTS WERE MADE TO DETACH THE COIL. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807865 ↗
• MalfunctionFeb 4, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TRANSVERSE SINUS ARTERIOVENOUS FISTULA LOCATED IN THE ELOQUENT REGION OF THE BRAIN. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). DETACHMENT COULD NOT BE ACHIEVED WITH INSTANT DETACHER OR SECONDARY METHOD. 3 OR 4 UNSUCCESSFUL ATTEMPTS WERE MADE WITH THE INSTANT DETACHER. IT WAS NOTED THERE WAS NO PROBLEM WITH THE INSTANT DETACHER. 1 UNSUCCESSFUL ATTEMPT WAS MADE TO DETACH THE COIL MANUALLY WITH THE HYPOTUBE. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER FROM THE SAME LOT WHICH WAS USED SUCCESSFULLY WITHOUT ISSUE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13462132 ↗
• MalfunctionOct 23, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT COIL WAS UNABLE TO BE ADVANCED OUT OF THE SHEATH. A NEW COIL WAS USED TO TREAT THE PATIENT. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE ANCILLARY DEVICES WERE DISCARDED AT THE SITE. NO PATIENT INJURY OCCURRED. NO IMAGES ARE AVAILABLE. ANCILLARY DEVICES: ECHELON - A961154 THIS EVENT OCCURRED DURING THE TREATMENT OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE ANEURYSM WAS UNRUPTURED AND SACCULAR. THE MAX DIAMETER WAS 2.3 MM AND THE NECK WAS 1.7 MM. THE BLOOD FLOW AND THE VESSEL ANATOMY WERE BOTH NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NEITHER THE COIL OR SHEATH WERE NOTICED TO HAVE BEEN DAMAGED. THE COIL WAS NOT ABLE TO EXIT THE SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10729671 ↗
• DeathMay 27, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Death

  MAUDE report 10092496 ↗
• MalfunctionAug 12, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY FOR AN ANEURYSM OF THE PSEUDO FACIAL ARTERY BRANCH OF THE EXTERNAL CAROTID ARTERY, ORIGINATED BY FIREWARE FRAGMENTS. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8886270 ↗
• DeathApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT OF PATIENT DEATH AFTER COILING. THE PATIENT PRESENTED WITH HEMORRHAGE. THE PATIENT HAD A RUPTURED, SACCULAR ANEURYSM. IT WAS REPORTED THAT THE PATIENT UNDERWENT COILING IN ORDER TO IMPROVE THE SITUATION. THE PATIENT UNDERWENT IMPLANTATION OF 13 COILS INCLUDING 9 MEDTRONIC COILS. THE PATIENT REPORTEDLY PASSED AWAY POST-PROCEDURE DUE TO THE MASSIVE HEMORRHAGE.

  Patient problems: Death

  MAUDE report 8483714 ↗

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