AxiumTM PC-3-8-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536033016), received between Jun 13, 2022 and Jun 13, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

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

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO AXIUM COILS OF THE SAME MODEL AND LOT THAT HAD RESISTANCE IN THE SHEATH AND AT THE CATHETER HUB. IT WAS REPORTED THAT SIGNIFICANT RESISTANCE WAS FELT AS THE DISTAL TIP OF THE COIL LEFT THE COILING SHEATH AND BEGAN ENTERING INTO THE CATHETER HUB. THE SURGEON FELT THE NON-TAPERED DISTAL SEGMENT OF THE COIL SHEATH AND GAP BETWEEN THE NON-TAPERED SHEATH AND THE HUB OF THE NON-MEDTRONIC BALLOON CATHETER "MAY CAUSE THE AXIUM COIL TO BREAK PREMATURELY AT THE GAP CAUSING HEAVY RESISTANCE TO OCCUR." THE COIL WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE PROCEDURE. THE EVENT WAS NOT ASSOCIATED WITH A PATIENT. CONCOMITANT DEVICE: MICROVENTION SCEPTOR C BALLOON ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO MALFORMATION OR DEFECT NOTED IN THE COILING SHEATH. THE DOCTOR STATED THAT AS THE NON-TAPERED COILING SHEATH OF MICRFX COIL ENTERS THE HUB A GAP CAN OCCUR WHICH CAUSES THE COIL THE BREAK AND THUS LEADS TO THE HEAVY RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681467 ↗
• MalfunctionJun 13, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT BOTH COILS ENCOUNTERED HEAVY RESISTANCE AT THE GAP BETWEEN NON TAPED COILING SHEATH AND MICROCATHETER HUB. THE BREAK WAS LOCATED AT THE GAP BETWEEN NON TAPERED COILING SHEATH ENTERING HUB OF THE MICROCATHETER. NO OTHER DAMAGES WERE NOTED BY THE PHYSICIAN IN REGARDS TO THE COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681403 ↗
• 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 14681301 ↗

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