AxiumTM QC-4-12-3D (UDI 00847536029972)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536029972), received between Mar 2, 2020 and Dec 19, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• MalfunctionDec 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE NO DETACHMENT ATTEMPTS MADE WITH THE INSTANT DETACHER OR MANUAL METHOD. THE COIL WAS NOT IMPLANTED AND HAD BEEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13040634 ↗
• MalfunctionJun 29, 2021Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE GUIDE CATHETER AND MICROCATHETER WERE IN PLACE DURING THE SURGERY, BUT THE COIL WAS STRETCHED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR TESTED, A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, AND THE COIL WAS NOT REPOSITIONED DURING THE PROCEDURE. A REPLACEMENT COIL WAS USED TO COMPLETE THE PROCEDURE. 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 MIDDLE CEREBRAL ARTERY (MCA) WITH A MAX DIAMETER OF 4.5 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ADDITIONAL INFORMATION RECEIVED INDICATED THE COIL STRETCH WAS NOTICED DURING DELIVERY, AND A CAUSE OF THE STRETCH COULD NOT BE DETERMINED. AN ECHELON-10 MICROCATHETER WAS USED (LOT #: B127350).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086303 ↗
• MalfunctionMar 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED IN THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT WITH A MAX DIAMETER OF 5.2MM AND A 2.1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT DURING DELIVERY OF THE AXIUM COIL, IT AUTOMATICALLY RELEASED IN THE MICROCATHETER IN ADVANCE, CAUSING THE COIL TO BE LEFT IN THE MICROCATHETER. THE SURGEON WITHDREW THE MICROCATHETER, THEN TOOK THE COIL OUT. THE AXIUM COIL WAS REPLACED WITH A NEW COIL TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT NO SURGICAL/MEDICAL INTERVENTION WAS REQUIRED, THERE WAS NO FRICTION DURING DELIVER, THE PUSHWIRE WAS NOT BENT OR BROKEN, THE COIL WAS NOT REPOSITIONED OR ROTATED, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9777243 ↗

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