AxiumTM QC-7-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536030060), received between Feb 3, 2022 and Jan 18, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THIS PATIENT HAD AN INTRACRANIAL ANEURYSM. DURING THE SURGICAL FILLING OF THE SPRING COIL, IT WAS FOUND THAT THE QC2-6-3D COULD NOT BE PUSHED. AFTER REPLACEMENT, THE PUSH WENT SMOOTHLY. THE COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THERE WAS NO DAMAGE OBSERVED ON THE CATHETER OR COIL. DURING THE SURGERY, IT WAS DISCOVERED THAT THE QC-7-30-3D SPRING COIL HAD DETACHED AUTOMATICALLY. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS FRICTION OF DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL TWICE. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED RIGHT ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.0MM AND A 2.0MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535441 ↗
• MalfunctionMay 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS BEING TREATED FOR A NEUROVASCULAR ABNORMALITY. IT WAS NO IN THE ELOQUENT REGION. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  WHILE THE COIL WAS BEING DEPLOYED ON THE ARTERIOVENOUS FISTULA (AVF) LESION, IT WAS DETACHED IN ADVANCE AND PUSHED INTO THE MICROCATHETER. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION AND REMAIN IN THE PATIENT. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DEPLOYMENT. 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. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO SYMPTOMS WERE REPORTED. ANCILLARY DEVICES: SL10 MICROCATHETER ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT INVOLVED TWO DIFFERENT AXIUM COILS WITH THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14311276 ↗
• MalfunctionMar 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS BEING TREATED FOR A NEUROVASCULAR ABNORMALITY. IT WAS NO IN THE ELOQUENT REGION. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  WHILE THE COIL WAS BEING DEPLOYED ON THE ARTERIOVENOUS FISTULA (AVF) LESION, IT WAS DETACHED IN ADVANCE AND PUSHED INTO THE MICROCATHETER. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION AND REMAIN IN THE PATIENT. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DEPLOYMENT. 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. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO SYMPTOMS WERE REPORTED. ANCILLARY DEVICES: SL10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13834626 ↗
• MalfunctionFeb 3, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS NOT ABLE TO BE DETACHED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE DETACHER TWO TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WERE TWO MANUAL ATTEMPTS TO DETACH VIA HYPOTUBE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN IFU. 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 IN THE P-COM WITH A MAX DIAMETER OF 7MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13443244 ↗

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