AxiumTM APB-4-10-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536008106), received between Dec 20, 2018 and Nov 10, 2020 — classified as 2 injuries, 1 malfunction.

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 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.

• InjuryNov 10, 2020Difficult or Delayed Positioning; Material Deformation; Physical Resistance/Sticking; Difficult or Delayed Positioning; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE 4X10 AXIUM COIL WAS INSERTED, BUT THEN REMOVED AS IT WAS NOT COILING IN THE DESIRED LOCATION WITHIN THE ANEURYSM. THE ECHELON MICROCATHETER TIP POSITION WAS THEN CHANGED, AND THE COIL WAS RE-INSERTED AND SUCCESSFULLY DETACHED. THE NEXT COIL USED WAS STIFF TO PUSH, AND THE CONTINUOUS FLUSH WASN'T RUNNING. AFTER A PAUSE, IT WAS NOTICED THE PUSHWIRE MARKER FROM THE 4X10 COIL WAS STILL ON THE SCREEN DESPITE HAVING BEEN REMOVED. IT WAS DISCOVERED THE DISTAL HALF OF THE PUSHWIRE HAD SNAPPED FREE FROM THE PROXIMAL HALF, AND WAS LODGED IN THE ECHELON. THE PUSHWIRE SEGMENT WAS THEN SUCCESSFULLY RETRIEVED. 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 AN ANEURYSM WITH NORMAL VESSEL TORTUOSITY. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. ON FOLLOW-UP, THE PHYSICIAN CLARIFIED THAT ONLY THE PROXIMAL END OF THE PUSHWIRE WAS RETRIEVED, THE DISTAL END OF THE PUSHWIRE REMAINED IMPLANTED IN THE PATIENT. IT WAS NOTED THAT DESPITE

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10815842 ↗
• MalfunctionFeb 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF AXIUM PRIME COIL PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF A RUPTURED AMORPHOUS ANEURYSM MEASURING 5.5 MM X 2 MM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE PATIENT¿S VASCULATURE WAS NORMAL IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL. IT WAS REPORTED THAT DURING THE PROCEDURE, THE AXIUM PRIME COIL WAS PUSHED FROM THE INTRODUCER SHEATH AND OBSERVED TO BE ALREADY RELEASED. THE COIL WAS NOT IMPLANTED IN THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURY AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8311588 ↗
• InjuryDec 20, 2018Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  MEDTRONIC RECEIVED REPORT THAT UNINTENDED DETACHMENT OF THE COIL OCCURRED DURING THE INSERTION THROUGH THE CATHETER. HOWEVER, THE COIL WAS ABLE TO BE PUSHED BY THE PUSHWIRE, AND BECAUSE IT WAS OUTSIDE THE ANEURYSM, THE CATHETER WAS PULLED, AND THE COIL WAS IMPLANTED IN THAT PLACE. SINCE THIS WAS A STENT ASSIST CASE, IT WAS DIFFICULT TO COLLECT THE COIL, THEREFORE IT WAS IMPLANTED BETWEEN THE VESSEL AND THE STENT FOR ABOUT 2CM. IT WAS CONFIRMED THAT BEFORE AND AFTER THE COMPLAINT COIL, OTHER COILS WERE ALSO PLACED. AND THAT, ALTHOUGH THE PROCEDURE WAS COMPLETED, IT WAS DELAYED. THE PATIENT WAS GIVEN ANTIPLATETELET MEDICATION PRIOR TO OPERATION. THE DEVICE WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSH WAS USED. THERE WAS NO KINK OR ABNORMALITY WITH THE DELIVERY PUSHER. THE RESISTANCE WAS ALSO NOT FELT. THE COIL WAS IMPLANTED AND ONLY THE DELIVERY PUSHER WAS COLLECTED. AT THE A1, ONE COIL LOOP MIGRATED. THERE HAS BEEN NO THROMBUS FORMATION. THIS EVENT OCCURRED DURING A CEREBRAL ANEURYSM (6MM) EMBOLIZATION PROCEDURE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE ANATOMY WAS MODERATE IN TORTUOSITY ANCILLARY DEVICE -RESTAR 14 STRAIGHT, GW NEUROUTE 14, NEUR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8185030 ↗

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