Axium QC-6-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462010390), received between Nov 20, 2019 and Apr 3, 2024 — classified as 2 malfunctions.

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

• MalfunctionApr 3, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COILS (LOT 225631674 AND LOT 226051945) WERE STRETCHED AND SUCCESSFULLY IMPLANTED AFTER REPLACEMENT. THE SPRING COIL (LOT 225062459) WAS NOT DETACHED SMOOTHLY, BUT IT WAS SUCCESSFULLY DETACHED AND IMPLANTED AFTER REPLACEMENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A CORONARY FISTULA. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032986 ↗
• MalfunctionNov 20, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THERE WAS A NON-DETACHMENT ISSUE WITH THE AXIUM IMPLANT COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER (ID). THEY ATTEMPTED TO DETACH THE COIL WITH THE MANUAL METHOD (BREAKING OF THE HYPO-TUBE, AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE) 3 (THREE) TIMES BUT WITHOUT SUCCESS. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED FUSIFORM ANEURYSM WITH A 6.5MM DIAMETER. THE PATIENT'S BLOOD FLOW WAS NORMAL AND THE VASCULATURE WAS NORMAL IN TORTUOSITY. THE DOCTOR DIDN'T PREPARE THE INSTANT DETACHER (ID) BEFORE THE SURGERY. USED MICROCATHETER TO DELIVER THE SPRING COIL. A HEADWAY17 ( MICROVENTION) WAS USED. NO DAMAGE WAS NOTED TO THE PUSHWIRE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, FUSIFORM, BASILAR ARTERY, DISSECTING ANEURYSM. THE MAX DIAMETER WAS 6.5MM. THE BLOOD FLOW AND THE VESSEL ANATOMY WERE BOTH NORMAL. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9348411 ↗

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