AxiumTM QC-2-6-HELIX (UDI 00847536029484)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536029484), received between Jul 27, 2020 and Apr 14, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 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.

• MalfunctionApr 14, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD RESISTANCE IN THE SHEATH AND AFTER SEVERAL ATTEMPTS TO PUSH INTO THE MICROCATHETER THE COIL DETACHED IN THE SHEATH. THE PATIENT WAS BEING TREATED FOR A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 5.2MM. THE PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  HE COIL COULD NOT BE PUSHED INTO THE MICROCATHETER. AFTER WITHDRAWING IN VITRO, TRIED TO PUSH THE GUIDE WIRE INTO THE MICROCATHETER, IT WAS SMOOTH. TRIED TO PUSH THE COIL OUT OF THE PROTECTIVE SHEATH IN VITRO, THE PUSH RESISTANCE WAS VERY LARGE. AFTER SEVERAL ATTEMPTS, THE COIL WAS DIRECTLY DETACHED IN THE PROTECTIVE SHEATH. THE SURGEON BELIEVED THAT THIS WAS A PRODUCT QUALITY PROBLEM. NO SYMPTOMS WERE REPORTED. ANCILLARY DEVICES: 6F SHEATH, 8F GUIDING CATHETERECHELON10 MICROCATHETER, SYNCHRO GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116381 ↗
• MalfunctionFeb 21, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE COIL WAS PUSHED OUT OF THE PROTECTIVE SHEATH, IT WAS VERY ASTRINGENT AND COULD NOT BE PUSHED INTO THE MICROCATHETER. LATER, THE GUIDE WIRE WAS USED TO TRY TO PUSH INTO THE MICROCATHETER, AND THE GUIDE WIRE COULD PUSH IN AND OUT SMOOTHLY. AFTER SEVERAL ATTEMPTS, THE COIL WAS DIRECTLY DETACHED IN THE PROTECTIVE SHEATH. THE OPERATOR BELIEVED THAT THIS WAS A PRODUCT QUALITY PROBLEM. WITHOUT ENTERED THE BODY, IT WAS DIRECTLY DETACHED IN THE PROTECTIVE SHEATH. NO SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT/BROKEN. THE THERE WAS NO FRICTION/DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION OR ATTEMPT TO DETACH THE COIL. THE CONTINUOUS FLUSH ADMINISTERED DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 6MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A 8F GUIDING CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13572865 ↗
• MalfunctionJul 27, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT WITH THE FIRST AXIUM COIL, THE INSTANT DETACHER (ID) AND MANUAL METHOD WERE EACH ATTEMPTED ONCE. WITH THE SECOND AXIUM COIL, THE ID WAS ATTEMPTED TWICE AND MANUAL DETACHMENT WAS ATTEMPTED ONCE. NO ISSUES WERE ENCOUNTERED PRIOR TO THE NON-DETACHMENT, AND NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. THE COILS WERE REPLACED AND THE SURGERY WAS COMPLETED.

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

  MAUDE report 10325992 ↗
• MalfunctionJul 27, 2020Separation Failure; Deformation Due to Compressive Stress; Separation Failure; Deformation Due to Compressive Stress

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT WITH THE FIRST AXIUM COIL, THE INSTANT DETACHER (ID) AND MANUAL METHOD WERE EACH ATTEMPTED ONCE. WITH THE SECOND AXIUM COIL, THE ID WAS ATTEMPTED TWICE AND MANUAL DETACHMENT WAS ATTEMPTED ONCE. NO ISSUES WERE ENCOUNTERED PRIOR TO THE NON-DETACHMENT, AND NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. THE COILS WERE REPLACED AND THE SURGERY WAS COMPLETED.

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

  MAUDE report 10325957 ↗

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