Axium Detachable Coil System QC-4-8-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536037762), received between Nov 20, 2024 and Nov 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 18, 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.

• MalfunctionNov 3, 2025Unintended Movement; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED THAT THE ECHELON DID NOT HAVE RESISTANCE DURING DELIVERY AND RETRIEVAL IN THIS EVENT. THERE WERE NO OTHER DEVICE ISSUES WITH THE ECHELON. THE CAUSE OF THE EVENT WAS NOT DETERMINED. RESISTANCE OCCURRED FOR THE SECOND PHENOM AND SECOND PIPELINE DEVICE IN THE DISTAL SECTION. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER OBSERVED FOR THE SECOND PHENOM AND PIPELINE DEVICES. THE FIRST PIPELINE DID NOT OPEN IN THE DISTAL SECTION. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451862 ↗
• MalfunctionMar 17, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED BY REMOVING THE SPRING COIL FROM THE BODY AS A WHOLE, AND ANOTHER SPRING COIL WAS USED FOR EMBOLIZATION. NO ISSUES WERE ENCOUNTERED PRIOR TO COIL NON-DETACHMENT. IT WAS NOTED THAT THERE WAS NO ABNORMALITY ON PUSHWIRE. THE PROXIMAL DETACHMENT POINT WAS KINKED, BUT THERE WAS NO SIGN OF BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619317 ↗
• MalfunctionNov 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED RIGHT CAVERNOUS SEGMENT OF INTERNAL CAROTID ARTERY WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 4.81 MM AND NECK DIAMETER 2.66 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL. THE VESSEL TORTUOSITY WAS MINIMAL. THE SPRING COIL HAS A LARGE RESISTANCE WHEN IT WAS DELIVERED TO THE MICROCATHETER PORT MULTIPLE TIMES. THE MICROCATHETER ENTERED THE ANEURYSM CAVITY WITH THE GUIDEWIRE. THE FIRST QC-4-8-3D WAS DELIVERED TO THE MICROCATHETER PORT THROUGH THE Y VALVE, WHICH HAD A LARGE RESISTANCE. IT WAS DELIVERED SEVERAL TIMES BUT IT WAS AGAINST THE CATHETER. TO PREVENT ACCIDENTS, THE SURGEON REPLACED IT WITH A ACHIEVA'S COIL, AND IT WAS DELIVERED NORMALLY THIS TIME. THEN THE SURGEON USED OUR COMPANY'S COILS AND SUCCESSFULLY FILLED 3 COILS. WHEN DELIVERING APB-1.5-4-3D-ES AND APB-1-3-HX-ES, THEY STILL COULD NOT ENTER THE MICROCATHETER. THE SURGEON REPLACED IT WITH A ACHIEVA'S COIL, AND THE EMBOLIZATION WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20739999 ↗

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