AxiumTM QC-3-8-3D (UDI 00847536029897)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536029897), received between Nov 19, 2019 and Apr 21, 2022 — classified as 1 injury, 6 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 18, 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 21, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT PRIOR TO USE IN THE PROCEDURE, THE TIP OF THE AXIUM COIL WAS FOUND TO BE DAMAGED. IT WAS NOTED THE COIL WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS NOT USED AND WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE FOR THE PROCEDURE. AS THE ISSUE WAS OBSERVED PRIOR TO USE, THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14172148 ↗
• MalfunctionMar 18, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL WAS KINKED AND WAS PREMATURELY DETACHED IN VIVO. THE PATIENT WAS BEING TREATED FOR AND UNRUPTURED, SACCULAR ANEURYSM IN THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY. THE MAX DIAMETER WAS 5.5MM AND THE NECK DIAMETER WAS 4.5MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTION FOR USE (IFU).  ANGIOGRAPHY SHOWED THAT THE TUMOR WAS LOCATED IN A1, AND THE TUMOR SIZE WAS ABOUT 5.5-4.5MM. USING AVIGO GUIDE WIRE (LOT NUMBER B183048) AND ECHELON10 (B231876) CATHETER, FIRST FILLED IN QC-6-20-3D, FORMED A HOOP PERFECTLY, SELECTED QC-5-15-3D TO FILL IN AGAIN, AND THEN FILLED IN TWO PIECES OF QC-4-12-3D IN TURN, CHOSE TO FILL IN ONE PIECE OF QC-3-8-3D AGAIN. WHEN THE SURGEON PULLED OUT THE COIL, HE FOUND THAT THE REAR END WAS KINKED. GENTLY PUSHED THE SPRING COIL TO DELIVER THE GUIDE WIRE IN VITRO, THE COIL WAS DEPLOYED IN VITRO, AND THEN IT WAS WITHDRAWN AND REPLACED WITH THE SAME MODEL OF PRODUCT, AND FINALLY PUT IN ONE QC-3-6-3D, TWO QC-2-6-3D, AND FINALLY PUT IN SAB -4-20, ASSISTED ANEURYSM EMBOLIZATION, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE PUSHWIRE WAS BENT AND IT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13815689 ↗
• MalfunctionNov 24, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THREE AXIUM COILS HAD RESISTANCE PUSHING OUT OF THE MICROCATHETER OR SHEATH AND ONE DETACHED IN THE MICROCATHETER WHEN TRYING TO BE WITHDRAWN. THE PATIENT WAS BEING TREATED FOR A RUPTURED SACCULAR ANEURYSM OF THE APEX OF THE BASILAR ARTERY. IT HAD A MAX DIAMETER OF 3MM AND A NECK OF 2.5MM. BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. IT WAS INDICATED THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  WHEN THE QC-3-8-3D COIL WAS USED FOR HOOP FORMATION, WHEN THE COIL BODY REACHED THE TIP OF THE MICROCATHETER, THERE WAS RESISTANCE TO PUSHING THE QC-3-8-3D SPRING COIL, AND THE TIP COULD NOT BE PUSHED OUT THE MICRO CATHETER. STUCK IN DISTAL END. WHEN THE SPRING COIL WAS WITHDRAWN, IT WAS FOUND THAT IT HAD BEEN DETACHED IN THE MICROCATHETER. AFTER REPLACING THE MICROCATHETER AND QC-3-8-3D SPRING COIL AGAIN, IT WAS FOUND THAT THE SPRING COIL COULD NOT PUSH OUT THE INTRODUCER SHEATH. SUBSEQUENTLY, IT WAS REPLACED WITH QC3-8-3D COIL, AND THERE WAS STILL RESISTANCE WHEN IT WAS PUSHED TO THE MICROCATHETER. AFTER IT WAS REPLACED WITH QC-3-6-3D AGAIN, IT WAS SUCCESSFULLY FILLED. FILLED IN JOHNSON & JOHNSON GELAXY-3-8, GELAXY2-4, QC1.5-2-

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870429 ↗
• InjuryMay 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COILS AND SOLITAIRE AB REMAIN IN THE RIGHT A1 AND A2 BLOOD VESSELS. THERE WERE NO PROBLEMS WITH THE QC-7-30-3D PUSHWIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11805135 ↗
• MalfunctionNov 18, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE QC-2-6-3D COIL WAS USED TO CLOSE THE DISTAL BLOOD VESSEL, BUT IT BECAME STRETCHED. IT WAS NOTED THERE WAS NO FRICTION, AND A CONTINUOUS FLUSH WAS USED. AFTER WITHDRAWAL, A REPLACEMENT COIL OF THE SAME TYPE WAS USED AND SURGERY CONTINUED. THE DISTAL EMBOLIZATION WAS COMPLETED, BUT WHEN THE QC-3-8-3D COIL WAS USED FOR THE PROXIMAL EMBOLIZATION, THE COIL COULD NOT BE DEPLOYED AFTER ADJUSTMENT. THE PHYSICIAN HAD NOT USED AN INSTANT DETACHER, AND THE MANUAL METHOD WAS USED ONCE. THE COIL FELL OFF WHEN IT WAS REMOVED FROM THE BODY. A REPLACEMENT COIL WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER ISSUES. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND 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 OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX D IAMETER OF 5 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A 6F-105 INTRACRANIAL SUPPORT CATHETER, AVIGO GUIDEWIRE, ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10865529 ↗
• MalfunctionNov 18, 2020Material Deformation; Material Deformation

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10863102 ↗
• MalfunctionNov 19, 2019Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT DURING THE ADVANCEMENT OF THE BARE AXIUM COIL INTO THE ANEURYSM, THE COIL UNWOUND AND DETACHED BEFORE IT REACHED THE MARK PLACE FOR RELEASING. THE COIL WAS REPLACED WITH A NEW COIL. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE VESSEL ANATOMY AND THE BLOOD FLOW WERE BOTH NORMAL. THIS EVENT OCCURRED DURING THE TREATMENT OF AN ANTERIOR COMMUNICATION ARTERY, THAT WAS SACCULAR AND UNRUPTURED. THE MAX DIAMETER WAS 4.7MM AND A NECK DIAMETER OF 3.4MM. NO PATIENT INJURY OCCURRED. THE COIL WAS ABLE TO EXIT THE PROTECTIVE SHEATH SMOOTHLY FOR HYDRATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9344833 ↗

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