AxiumTM PC-3-8-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536033214), received between Oct 18, 2021 and Jun 13, 2022 — classified as 3 malfunctions.

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

• MalfunctionJun 13, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT THREE AXIUM COILS HAD SIGNIFICANT RESISTANCE IN THE SHEATH WHEN TRYING TO ADVANCE INTO THE CATHETER HUB DUE TO ROBBIN-TAPERED COIL SHEATH. IT WAS NOTED THAT THE COILS AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR INJURY WERE REPORTED. ANCILLARY DEVICE: STRYKER SL-10 MICROCATHETER ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO MALFORMATION OR SUSPECTED DEFECT OF THE COIL SHEATH. THE GAP BETWEEN THE COILING SHEATH AND HUB CAUSED THE COIL TO BREAK BEFORE ENTERING THE COILING CATHETER CAUSING THE HEAVY RESISTANCE. THE COIL NEVER ENTERED INTO THE COILING CATHETER OR PATIENT. THERE WERE NO COMPLICATIONS AS THEY WERE NOT USED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681228 ↗
• MalfunctionJun 13, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT THREE AXIUM COILS HAD SIGNIFICANT RESISTANCE IN THE SHEATH WHEN TRYING TO ADVANCE INTO THE CATHETER HUB DUE TO ROBBIN-TAPERED COIL SHEATH. IT WAS NOTED THAT THE COILS AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR INJURY WERE REPORTED. ANCILLARY DEVICE: STRYKER SL-10 MICROCATHETER ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO MALFORMATION OR SUSPECTED DEFECT OF THE COIL SHEATH. THE GAP BETWEEN THE COILING SHEATH AND HUB CAUSED THE COIL TO BREAK BEFORE ENTERING THE COILING CATHETER CAUSING THE HEAVY RESISTANCE. THE COIL NEVER ENTERED INTO THE COILING CATHETER OR PATIENT. THERE WERE NO COMPLICATIONS AS THEY WERE NOT USED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681214 ↗
• MalfunctionOct 18, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN KINKED THE COIL PUSHER IN 2 PLACES DURING USE AND THE COIL THEN COULD NOT BE USED. WHEN TRYING TO RESHEATH THE COIL, IT DETACHED IN THE HUB OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647768 ↗

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