Axium Detachable Coil System QC-6-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037847), received between Nov 18, 2024 and Jan 30, 2026 — classified as 2 malfunctions.

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

• MalfunctionJan 30, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER. THE PATIENT WAS UNDERGOING RENAL ARTERY EMBOLISM SURGERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT DURING A RENAL ARTERY EMBOLIZATION PROCEDURE, THE OPERATOR USED A TERUMO MICROCATHETER TO DELIVER THE AXIUM COIL. WHEN THE COIL WAS DELIVERED TO THE MIDSECTION OF THE MICROCATHETER, DELIVERY BECAME DIFFICULT AND THE COIL COULD NOT BE ADVANCED FURTHER. AFTER DETACHING THE COIL WITHIN THE MICROCATHETER, THE OPERATOR ATTEMPTED TO FLUSH FROM THE PROXIMAL END WITH A SYRINGE TO PUSH THE COIL FURTHER DISTALLY, BUT FAILED. A NEW COIL WAS THEN USED INSTEAD TO CONTINUE THE PROCEDURE. THE COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THE PERIPHERAL INTERVENTIONAL COIL COULD NOT BE ADVANCED INTO THE MICROCATHETER. THE CATHETER WAS NOT DAMAGED. THE COIL WAS NOT DAMAGED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. ANCILLARY DEVICES INCLUDE THE TERUMO MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226568 ↗
• MalfunctionNov 18, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL WAS ATTEMPTED TO BE DETACHED WITH THE DETACHER 8 TIMES. THERE WAS NO ATTEMPT WITH THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20715889 ↗

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-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
• 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