Axium Detachable Coil System QC-25-50-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536038035), received between Nov 4, 2022 and Nov 14, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT DURING TRANSHEPATIC INTRAJUGULAR PORTOSYSTEMIC SHUNT (TIPS) SURGERY FOR VASCULAR MALFORMATION EMBOLIZATION, THE AXIUM PRIME BARE COIL WAS SELECTED FOR DELIVERY, AND THE SPRING COIL WAS STRETCHED. IT WAS REPLACED WITH A NEW MEDTRONIC COIL TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE LESION WAS CHARACTERIZED AS PORTAL VEIN VARICOSE VEINS. THE TIMING OF WHEN THE STRETCH WAS OBSERVED IS UNKNOWN. NO ISSUES WERE REPORTED THAT RESULTED IN THE DAMAGE FOUND. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF VARICOSE VEINS THAT WERE NOT LOCATED IN THE ELOQUENT REGION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MINIMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560459 ↗
• MalfunctionNov 14, 2025Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT DURING TRANSHEPATIC INTRAJUGULAR PORTOSYSTEMIC SHUNT (TIPS) SURGERY FOR VASCULAR MALFORMATION EMBOLIZATION, THE AXIUM PRIME BARE COIL WAS SELECTED FOR DELIVERY, AND THE SPRING COIL WAS STRETCHED. IT WAS REPLACED WITH A NEW MEDTRONIC COIL TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE LESION WAS CHARACTERIZED AS PORTAL VEIN VARICOSE VEINS. THE TIMING OF WHEN THE STRETCH WAS OBSERVED IS UNKNOWN. NO ISSUES WERE REPORTED THAT RESULTED IN THE DAMAGE FOUND. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF VARICOSE VEINS THAT WERE NOT LOCATED IN THE ELOQUENT REGION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MINIMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560442 ↗
• MalfunctionApr 17, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT BARE AXIUM 3D COIL WAS NOT DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 23 MM AND A 12 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER THE SPRING COIL WAS TAKEN OUT OF THE PACKAGE, IT WAS INSERTED INTO THE ECHELON MICROCATHETER, AND THE SPRING COIL WAS DETACHED AFTER THE ENTIRE SPRING COIL WAS PUSHED. AFTER BREAKING THE DETACHMENT POINT AT THE TAIL OF THE PUSH ROD AND COMPLETELY PULLING OUT THE NYLON THREAD, THE PUSH ROD WAS PULLED BACK AND IT WAS FOUND THAT THE SPRING COIL HAS NOT BEEN DETACHED. THE UNDETACHED SPRING COIL WAS THEN RETRIEVED AND REPLACED WITH A SPRING COIL OF THE SAME MODEL TO COMPLETE FORMING A HOOP AND SUCCESSFULLY DETACHED IT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE AN ECHELON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860072 ↗
• MalfunctionNov 4, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL COULD NOT BE DETACHED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER.  ANCILLARY DEVICES INCLUDE A ECHELON MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725446 ↗

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