Axium QC-14-40-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00836462010499), received between Sep 5, 2024 and Oct 23, 2024 — 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.

• MalfunctionOct 23, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS STUCK IN THE CENTER OF THE CATHETER. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED RIGHT IC-PC ANEURYSM WITH A SACCULAR MORPHOLOGY. SIZE OF ANEURYSM: MAXIMUM DIAMETER OF ANEURYSM 20 MM AND NECK DIAMETER OF ANEURYSM 7 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. DURING INSERTION OF THE COIL INTO THE CATHETER AND GUIDANCE TO THE ANEURYSM, THE COIL COULD NOT ADVANCE AT THE TIMING WHEN IT WAS PO SITIONED AT ABOUT HALF THE CATHETER LENGTH. IT DID NOT ADVANCE EVEN WHEN IT WAS PULLED AND PUSHED AGAIN; IT WAS COLLECTED. LOOKING AT THE COLLECTED COIL, IT WAS UNRAVELED. A THROMBUS FORMED IN THE CATHETER, AND THIS MIGHT HAVE CAUSED THE COIL RESISTANCE. THE COIL WAS REMOVED WHILE IT WAS STUCK, SO IT WAS PREDICTED THAT IT MIGHT HAVE BEEN UNRAVELED. IT WAS UNKNOWN IF THE CATHETER WAS DAMAGED. DAMAGE TO THE COIL WAS NOTED. COIL SEPARATION/BREAK/PREMATURE DETACHMENT WAS NOTED. THE COIL WAS REMOVED OUTSIDE THE BODY BY THE WIRE BEING PULLED AND COLLECTED. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519440 ↗
• MalfunctionSep 9, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO HEALTH IMPACT. THE CAUSE OF THE COIL BREAK WAS NOTED THAT THE BLOOD CLOT WAS FORMED IN THE CATHETER AND CAUSED THE COIL TO GET STUCK. IT WAS SUSPECTED THAT THE COIL WAS UNLABELED BECAUSE IT WAS PULLED OUT IN A STUCK STATE. THE COIL WAS ABLE TO ADVANCE FROM THE SHEATH INTO THE MICROCATHETER, BUT IT BECAME DIFFICULT TO BE GUIDED IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 20171485 ↗
• MalfunctionSep 5, 2024Break; No Apparent Adverse Event; Physical Resistance/Sticking; Break; No Apparent Adverse Event; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL WAS STUCK IN THE CATHETER. DURING INSERTION OF THE COIL INTO THE CATHETER AND GUIDING IT TO THE ANEURYSM, THE COIL COULD NOT ADVANCE AT THE TIMING WHEN IT APPROACHED ABOUT HALF THE CATHETER LENGTH. IT DID NOT ADVANCE EVEN WHEN IT WAS PULLED AND PUSHED AGAIN; IT WAS COLLECTED. LOOKING AT THE COLLECTED COIL, IT WAS BROKEN. A THROMBUS FORMED IN THE CATHETER, SO IT MIGHT HAVE BEEN A COIL STUCK. THE COIL WAS REMOVED WHILE IT WAS STUCK, SO IT WAS PREDICTED THAT IT MIGHT HAVE BEEN BROKEN. THE COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR ANEURYSM IN THE RIGHT INTERNAL CAROTID-PC LOCATION. THE ANEURYSM MAX DIAMETER WAS 20MM AND THE NEKC DIAMETER WAS 7MM. PATIENT BLOOD FLOW SPEED WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ANCILLARY DEVICES: SL-10 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154042 ↗

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