AxiumTM PC-2-6-3D (UDI 00847536014145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536014145), received between Jul 5, 2018 and Aug 2, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ISSUES ENCOUNTERED DURING THE PROCEDURE PRIOR TO THE COIL NON-DETACHMENT. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259924 ↗
• MalfunctionJul 5, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COILS DID NOT DETACH. THE PATIENT WAS UNDERGOING A VESSEL TAKE DOWN SURGERY TO TREAT A TUMOR. IT WAS STATED THAT THE FIRST COIL DID NOT DETACH. AS A RESULT A SECOND COIL OF THE SAME SIZE AND LOT NUMBER WERE USED WHICH ALSO FAILED TO DETACH. THE HEALTHCARE PROFESSIONAL (HCP) ATTEMPTED TO DETACH THE COIL 4 TIMES WITH THE INSTANT DETACHER AND 2 TIMES WITH A MANUAL METHOD, WITH NO OTHER INSTANT DETACHER ATTEMPTED, BUT THE ISSUE WAS UNRESOLVED. NO ISSUE WITH THE INSTANT DETACHER WAS NOTED. THERE WERE NO RELATED PATIENT SYMPTOMS. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT HAD A NORMAL VESSEL TORTUOSITY. THE PATIENT WAS ULTIMATELY TREATED WITH A DIFFERENT COIL AND ARE CURRENTLY IN GOOD CONDITION. THERE WAS NO DAMAGE TO THE PUSHWIRE NOTED ONCE IT WAS REMOVED FROM THE PATIENT, AND A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7664502 ↗
• MalfunctionJul 5, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COILS DID NOT DETACH. THE PATIENT WAS UNDERGOING A VESSEL TAKE DOWN SURGERY TO TREAT A TUMOR. IT WAS STATED THAT THE FIRST COIL DID NOT DETACH. AS A RESULT A SECOND COIL OF THE SAME SIZE AND LOT NUMBER WERE USED WHICH ALSO FAILED TO DETACH. THE HEALTHCARE PROFESSIONAL (HCP) ATTEMPTED TO DETACH THE COIL 4 TIMES WITH THE INSTANT DETACHER AND 2 TIMES WITH A MANUAL METHOD, WITH NO OTHER INSTANT DETACHER ATTEMPTED, BUT THE ISSUE WAS UNRESOLVED. NO ISSUE WITH THE INSTANT DETACHER WAS NOTED. THERE WERE NO RELATED PATIENT SYMPTOMS. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT HAD A NORMAL VESSEL TORTUOSITY. THE PATIENT WAS ULTIMATELY TREATED WITH A DIFFERENT COIL AND ARE CURRENTLY IN GOOD CONDITION. THERE WAS NO DAMAGE TO THE PUSHWIRE NOTED ONCE IT WAS REMOVED FROM THE PATIENT, AND A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7663642 ↗

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