AxiumTM QC-2-6-3D (UDI 00847536029828)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536029828), received between Aug 31, 2020 and Dec 28, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2023Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL STRETCHED DURING DELIVERY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A LEFT CAVERNOUS SINUS SEGMENT ANEURYSM. THE ANEURYSM WAS RUPTURED WITH A AMORPHOUS MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 8.2 MM, NECK DIAMETER 4 MM. THE PATIENT'S BLOOD FLOW WAS NORMAL. THE VESSEL TORTUOSITY WAS MINIMAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. COIL WAS DELIVERED TO THE MICROCATHETER AND HALFWAY THROUGH THE DELIVERY THE COIL STRETCHED. ADDITIONAL INFORMATION RECEIVED THAT AFTER TAKING THE COIL OUT AND DELIVERING IT, IT WAS FOUND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415858 ↗
• MalfunctionMar 24, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS STUCK IN THE SHEATH AND COULD NOT BE PUSHED INTO THE MICROCATHETER AFTER PREPARATION. THE DEVICE WAS REPLACED, AND THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED. THE COIL WAS PREPPED PER IFU, BUT THE ACCOUNT WAS NOT SURE IT WAS HELD VERTICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13876558 ↗
• MalfunctionDec 7, 2021Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS BENT OUT OF THE PACKAGE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE LEFT INTERNAL COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE COIL CAME OUT OF PACKAGE WITH THE WIRE BENT. THE DAMAGE WAS ON THE PUSHWIRE PROXIMAL SEGMENT. PHYSICIAN WASN¿T COMFORTABLE USING IN PATIENT. THE COIL WAS NEVER PLACED IN A CATHETER OR THE PATIENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE DAMAGE TO THE DEVICE WAS NOTED UPON OPENING THE PACKAGE, AND NO PREPARATION HAD BEEN PERFORMED. THE PROXIMAL END OF THE PUSHWIRE HAD BEEN SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957619 ↗
• MalfunctionOct 21, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE TO THE PUSHWIRE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673620 ↗
• MalfunctionSep 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DETACHED IN THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 3.1MM AND A 2.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE SPRING COIL WAS DETACHED IN THE MICROCATHETER, THE MICROCATHETER AND THE SPRING COIL WERE WITHDRAWN AT THE SAME TIME, AND THE SPRING COIL IN THE MICROCATHETER WAS PUSHED OUT WITH THE PUSH WIRE. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, THEY DID NOT ATTEMPT TO DETACH THE COIL, THEY DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421286 ↗
• MalfunctionJun 10, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. FOUR MANUAL DETACHMENT ATTEMPTS WERE MADE, AND NO KINK/DAMAGE WAS OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975832 ↗
• MalfunctionNov 9, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE COIL WAS NOT ALREADY DETACHED WHEN REMOVED FROM PACKAGING AND DID NOT DETACH DURING PREPARATION. THE PROXIMAL END OF THE PUSHWIRE HAD BEEN SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED, AND NO DAMAGE OR EVIDENCE OF TAMPERING WAS NOTED TO THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10810132 ↗
• MalfunctionNov 4, 2020Separation Failure; Material Deformation; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF A SEGMENT OF THE LEFT OPHTHALMIC ARTERY. THE ANEURYSM MAX DIAMETER WAS 5.8MM AND THE NECK DIAMETER WAS 3.6MM. BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS DELIVERED TO THE ANEURYSM. HOWEVER, IT COULD NOT BE DETACHED. 3 ATTEMPTS WERE MADE TO DETACH THE COIL WITH THE INSTANT DETACHER (ID) WITHOUT SUCCESS. 2 ATTEMPTS WERE THEN MADE TO DETACH THE COIL VIA MANUAL METHOD. THE COIL WAS WITHDRAWN FROM THE PATIENT'S BODY AND REPLACED WITH ANOTHER COIL TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE ID OR ANY OF THE OTHER ACCESSORY DEVICES. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10786739 ↗
• MalfunctionAug 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WASN'T IMPLANTED AND REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10474044 ↗

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