AxiumTM QC-2-6-3D (UDI 00847536017436)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536017436), received between Dec 11, 2018 and Apr 19, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ECHELON-10 WAS IN PLACED, AND THE COIL WAS DELIVERED; HOWEVER, THE PUSH RESISTANCE OF THE COIL WAS LARGE, AND WHEN IT WAS WITHDRAWN, IT WAS FOUND THAT THE OUT SHEATH WAS TOO TIGHT RESULTING IN NOT BEING ABLE TO BE PUSHED OUT. THE COIL WAS REPLACED WITH THE SAME MODEL PRODUCT, PUSHED SMOOTHLY, AND SUCCESSFULLY IMPLANTED. 3 MORE COILS WERE IMPLANTED AFTER, AND THE SURGERY WAS OVER. THE PATIENT WAS UNDERGOING SURGERY TO TREAT A RUPTURED, SACCULAR ANEURYSM OF THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5MM AND A NECK DIAMETER OF 3MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED REPORTED THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691201 ↗
• MalfunctionSep 30, 2020Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE COILING TREATMENT OF UNRUPTURED, SACCULAR, RIGHT INTERNAL CAROTID ARTERY ANEURYSM, THIS COIL STUCK INSIDE THE INTRODUCER SHEATH. IT WAS REPORTED THAT DURING INTRODUCTION OF THE SPRING, THERE WAS A ROUGHNESS IN THE SHEATH (APPLICATION INTRODUCER) OF THE SPRING MAKING THE SPRING OUT OF THE WAY. THERE WAS NO DECOUPLING OF THE SPIRAL FROM THE TIP OF THE IMPLANT INTRODUCER. PREVENTING THE CONTINUITY OF THE PROCEDURE. THE PATIENT¿S BLOOD FLOW WAS NORMAL. NO PATIENT INJURY WAS REPORTED. THE COIL WAS HYDRATED PER THE IFU. DIFFERENT SIZES OF COILS WERE USED AND PATIENT TREATED. COIL WAS REMOVED FOR EVALUATION, AND WAS FOUND TO BE STRETCHED IN ITS PROXIMAL THIRD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10604253 ↗
• MalfunctionDec 17, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS COIL RESISTANCE AT THE MICROCATHETER HUB AND THE PUSHER WIRE WAS KINKED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED, RIGHT DACA ANEURYSM WITH A MAX DIAMETER OF 3.2MM AND A 1.4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PHYSICIAN HYDRATED THE COIL WITH FLUSH BACK TECHNIQUE AND STARTED TO DEPLOY INSIDE THE MICROCATHETER. INITIALLY, A LOT OF RESISTANCE WAS FELT AT THE CATHETER HUB, SO THE COIL WAS TAKEN OUT OF THE MICROCATHETER. THE COIL WAS CHECKED BY PUSHING IT INTO A SALINE TRAY, AND IT WAS FOUND THE PUSHER WIRE WAS KINKED AT THE DISTAL PART AND THE DETACHMENT ZONE. NO DAMAGED WAS NOTED TO THE CATHETER, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9483161 ↗
• MalfunctionAug 26, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT UPON PREP AND ADVANCEMENT OF THE COIL, SHEATH FRICTION WAS OBSERVED, THERE WERE NOT ABLE TO PUSH OR TRANSFER THE COIL INTO THE MICROCATHETER. THE COIL WAS INSPECTED AND COULD NOT BE ADVANCED THROUGH THE SHEATH ON THE BENCH. THE COIL WAS HYDRATED PER THE IFU. THERE WAS NO KINK/DAMAGE TO THE COIL. THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THE PATIENT WAS ULTIMATELY TREATED WITH ANOTHER MANUFACTURER'S COILS. THE PATIENT WAS BEING TREATED FOR NEUROVASCULAR ABNORMALITIES, AND THE GRADE TYPE WAS FISTULA. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. ANCILLARY DEVICE: NEURON MAX SHEATH, SL10 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8931196 ↗
• MalfunctionMay 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT BARE AXIUM COIL ENCOUNTERED RESISTANCE WHEN IT WAS ADVANCED IN THE MICROCATHETER. UPON RETRIEVAL OF THE PUSHWIRE, IT WAS REALIZED THAT THE DISTAL SECTION OF PUSHWIRE HAD BROKEN. THE COIL WAS REPLACED WITH THE SAME MODEL AND THE CASE WAS COMPLETED. NO PATIENT INJURY OCCURRED. A CONTINUOUS FLUSH WAS USED DURING THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8611550 ↗
• MalfunctionMar 14, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT TWO AXIUM COILS WERE STUCK IN THE HUBS OF TWO MICROCATHETERS. THE DEVICES WERE REPLACED WITH MEDTRONIC DEVICES TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE COILS WERE REPORTED TO HAVE BEEN PUSHED SMOOTHLY OUT OF THE INTRODUCER SHEATHS AND THE SHEATHS WERE SEATED SECURELY IN THE HUB OF THE MICROCATHETERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8422047 ↗
• MalfunctionDec 11, 2018Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE DETACHED USING THE INSTANT DETACHER OR MANUAL METHOD. FURTHERMORE, WHEN THE PHYSICIAN ATTEMPTED TO PULL BACK AND REPLACE THE COIL IT BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN THEN PUSHED THE COIL FORWARD AGAIN INTO THE CATHETER CAUSING IT TO GO INTO THE ANEURYSM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RUPTURED, SACCULAR, ACOM ANEURYSM WITH A MAX DIAMETER OF 2.8MM AND A NECK DIAMETER OF .89MM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY AND BLOOD FLOW WERE NORMAL. THERE WAS NO COIL OR CATHETER DAMAGE NOTICED. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8151283 ↗

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-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
• 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