Axium QC-8-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00836462010437), received between Apr 1, 2019 and Jul 18, 2023 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE COIL WAS WITHDRAWN FROM THE ANEURYSM TO ADJUST ITS POSITION, IT COULD NOT BE PUSHED. THE COIL WAS STUCK IN THE MICROCATHETER. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 7MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE RESISTANCE WAS LOCATED IN THE MIDDLE OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343533 ↗
• MalfunctionDec 8, 2022Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. PRIOR TO COIL NON-DETACHMENT, NO OTHER PROBLEMS WERE ENCOUNTERED EXCEPT PUSH RESISTANCE. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939832 ↗
• MalfunctionOct 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROVIDER DIDN¿T FIND ANY KINK/DAMAGE ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584672 ↗
• MalfunctionMar 25, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A QC-8-20-3D COIL HAD BEEN DELIVERED AND DETACHED SUCCESSFULLY. THE REPORTED QC-8-30-3D COIL WAS THEN POSITIONED IN THE ANEURYSM WITHOUT ISSUE. THE INSTANT DETACHER THEN FAILED TO DETACH THE COIL THREE TIMES, AND A SECOND INSTANT DETACHER WAS NOT USED. THE PHYSICIAN NOTICED THE PROXIMAL PART OF THE PUSHWIRE HAD BROKEN ALONG WITH THE FILAMENT. THE MANUAL DETACHMENT METHOD WAS THEN PERFORMED ONCE BY BREAKING THE PUSHER AND PULLING ON THE FILAMENT. THE COIL DID NOT DETACH, AND WAS THEN RETRIEVED. SUBSEQUENT COILS WERE SUCCESSFULLY DETACHED USING THE SAME DETACHER AND THEN IT WAS DISCARDED AFTER THE CASE. IT WAS REPORTED THERE WAS NO ISSUE WITH THE INSTANT DETACHER. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) PARAC LINOID SEGMENT WITH A MAX DIAMETER OF 20 MM AND A NECK DIAMETER LESS THAN 5 MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ANCILLARY DEVICES INCLUDE A MICRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568265 ↗
• MalfunctionAug 19, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT TWO BARE AXIUM COILS FAILED TO BE DETACHED. QC-7-20-3D: 5 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER; 2 ADDITIONAL DETACHMENT ATTEMPTS WERE MADE WITH A SECOND INSTANT DETACHER AND 2 MANUAL DETACHMENTS. QC-8-30-3D: 3 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER; 3 ADDITIONAL DETACHMENT ATTEMPTS WERE MADE WITH A SECOND INSTANT DETACHER AND 2 MANUAL DETACHMENTS. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8907741 ↗
• MalfunctionApr 1, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THIS 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). THE PATIENT UNDERWENT COILING TREATMENT FOR A RUPTURED SACCULAR ANEURYSM. THE VESSEL WAS OBSERVED SEVERELY TORTUOUS. IT WAS REPORTED THAT THE COMPLAINT COIL WAS THE 7TH COIL, IN THAT CASE. PROF. FELBER TRIED TO DETACH THE COIL WITH THE ID DETACHER, IT WAS NOT POSSIBLE. THAN HE TRIED THE EMERGENCY RELEASE AT THE END OF THE PUSHWIRE, THAT ALSO DIDN'T WORK. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL THREE TIMES WITH INSTANT DETACHER AND ONE TIME WITH USING MANUAL METHOD, BUT COIL DID NOT DETACH. THE PHYSICIAN REMOVED THE COIL AND TRIED ANOTHER ON WITH A NEW DETACHER, THAT WENT WELL. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT DIED, AND CAUSE OF DEATH IS MASSIVE IHB. COILING WAS A TRY TO GET THE SITUATION BETTER, BUT IT WAS TOO MASSIVE. PATIENT DATE OF DEATH: ASKED AND WILL NOT BE MADE AVAILABLE (LEGAL/CONFIDENTIAL REASON) HEADWAY 17, TRACXESS 14, INSTANT DETACHER WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8471956 ↗

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