AXIUM PC-7-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836462010864), received between Aug 5, 2019 and Aug 5, 2019 — classified as 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT OF COIL NON-DETACHMENT THE PATIENT WAS UNDERGOING COILING TREATMENT FOR A SMALL UNRUPTURED SACCULAR ANEURYSM LOCATED IN RIGHT INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE VESSEL WAS MODERATELY TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL WAS UNABLE TO DETACH USING TWO INSTANT DETACHERS. THREE DETACHMENT ATTEMPTS WERE MADE USING EACH DETACHER. THE DETACHERS WERE HEARD TO BE CLICKING, BUT WERE NOT FUNCTIONING. MANUAL DETACHMENT WAS ATTEMPTED ONCE. THE COIL WAS NOT IMPLANTED. THE REMAINDER OF THE PROCEDURE WAS COMPLETED WITH ADDITIONAL COILS WITHOUT FURTHER ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8862882 ↗

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