Axium Detachable Coil System QC-14-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037977), received between Aug 28, 2023 and Jul 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN FIST COIL INSERTED INTO THE CATHETER, IT STUCK IN THE MIDDLE AND WHEN PULLED, IT WAS BROKEN. THE SECOND COIL WAS INSERTED INTO THE CATHETER, SAME PROBLEM HAPPENED. WHEN WE USE THE THIRD COIL (AXIUM 9X30 3D) IT WAS SUCCESSFUL. THE COILS WERE STUCK IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS NOT DAMAGED. THE COIL WAS DAMAGED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT NEUROVASCULAR ABNORMALITIES. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND V ESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICES INCLUDE A ECHELON (MEDTRONIC) 105-5091-150; AVIGO (MEDTRONIC) 103-0606-200 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649139 ↗
• MalfunctionAug 28, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT 3 DETACHERS WERE USED AND 9-10 DETACHMENT ATTEMPTS IN TOTAL WERE MADE. THERE WERE 3 MANUAL DETACHMENT ATTEMPTS. THE CUSTOMER ENSURED THAT THE 1ST TWO DETACHERS WERE THE SAME BATCH NUMBER AND THE 3RD WAS A DIFFERENT BATCH NUMBER. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO COIL NON-DETACHMENT. IT WAS UNKNOWN IF THERE WAS ANY PUSHWIRE DAMAGE AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17637713 ↗

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