AxiumTM QC-2-8-HELIX (UDI 00847536029491)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536029491), received between May 25, 2021 and Aug 25, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE COIL HAD RESISTANCE AT THE END OF THE INTRODUCER SHEATH AND COULD NOT BE PUSHED INTO THE MICROCATHETER. THE COIL WAS REMOVED AND TESTED IN VITRO AND IT WAS STILL DIFFICULT TO PUSH OUT OF THE SHEATH. IT WAS NOTED THAT THE DEVICE HAD BEEN PREPARED PER IFU. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR RIGHT OPHTHALMIC ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5.2MM AND THE NECK DIAMETER WAS 2.9MM. VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294754 ↗
• MalfunctionFeb 10, 2022Separation Failure; Separation Failure

  (B)(6) 2022 (B)(4) (REP, FOR): MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL COULD NOT BE DETACHED AFTER 3 TIMES OF NORMAL DETACHMENT. IT WAS UNKNOWN IF THE PHYSICIAN ATTEMPTED TO DETACH VIA ANOTHER INSTANT DETACHER OR VIA A HYPOTUBE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 4MM AND A 3MM NECK DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13510858 ↗
• MalfunctionMay 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5.29MM, AND THE NECK DIAMETER WAS 2.58MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE SPRING COIL WAS PUSHED INTO THE MICROCATHETER AND DELIVERED INTO THE SKULL UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND DETACHED BEFORE THE DETACHING ZONE. THE FOLLOW-UP COIL WAS USED TO PUSH THE ABNORMALLY DETACHED SPRING COIL INTO THE ANEURYSM, BUT BECAUSE IT WAS ALREADY IN A FREE STATE, THE FILLING POSITION AND EFFECT OF THE COIL COULD NOT BE ADJUSTED AND SOME HERNIATED INTO THE CURRENT-CARRYING ARTERY. THE COIL REMAINS IN THE PATIENT AND WAS NOT IMPLANTED IN THE INTENDED LOCATION. THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE HAD BEEN NO FRICTION/DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED. THE SAME CATHETER WAS USED TO PUSH OTHER COILS SMOOTHLY. NO A

  Patient problems: Foreign Body In Patient

  MAUDE report 11878437 ↗

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