AxiumTM APB-4-8-HX-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536008175), received between Feb 21, 2021 and Jul 22, 2024 — classified as 1 injury, 3 malfunctions.

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

• InjuryJul 22, 2024Therapy Delivered to Incorrect Body Area; Migration; Therapy Delivered to Incorrect Body Area; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED NO ANOMALOUS SHAPE WAS DETERMINED. THERE WAS NO ISSUES THAT RESULTED IN THE COIL DAMAGE. NO MEDICAL OR SURGICAL INTERVENTION IS PLANNED. THE ANTIPLATELET REGIMEN WAS ADMNISTERED AFTER THE PROCEDURE. NO PATIENT SYMPTOSM OR C OMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19791358 ↗
• MalfunctionJun 26, 2024Stretched; Stretched

  MEDTRONIC RECEIVED REPORT REGARDING THREE DIFFERENT AXIUM COILS THAT WERE STRETCHED DURING THE PROCEDURE. EACH TIME THE STRETCHED COIL WAS REPLACED AND THE REPLACEMENT COIL WAS IMPLANTED SUCCESSFULLY. IT WAS NOTED THAT ALL INVOLVED DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). PATIENT VESSEL TORTUOSITY WAS REPORTED TO BE NORMAL. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY OR POSITIONING. THE CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617736 ↗
• MalfunctionNov 30, 2022Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE HELIX COIL WAS INSERTED INTO SL10 CATHETER, THE COIL WAS REMOVED DUE TO DISCOMFORT. WHEN THE COIL WAS REMOVED, IT WAS FOUND THAT THE COIL HAD DETACHED. THE COIL WAS SLIGHTLY PROTRUDING FROM THE SL10 HUB. THERE WAS COIL BREAKAGE/EARLY DETACHMENT. THE COIL WAS REMOVED FROM THE BODY AND HUB USING A PUNCTURE NEEDLE. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. IT WAS UNKNOWN IF THERE WAS ANY DEFORMATION OR BREAKAGE IN THE DELIVERY PUSHER. THERE WAS RESISTANCE DURING DELIVERY. THE COIL WAS NOT REPOSITIONED. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE DELIVERY PUSHER DID NOT ROTATE INSIDE THE PATIENT. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PREPARATION OF THE DEVICE FOLLOWED THE INSTRUCTIONS IN THE PACKAGE INSERT. NO HEALTH DAMAGE WAS PRESENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SPINDLE SHAPED, UNRUPTURED RIGHT M1 DOWNWARD ANEURYSM WITH A MAX DIAMETER OF 9MM AND A 3.5MM NECK DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885887 ↗
• MalfunctionFeb 21, 2021Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS ABNORMAL WHEN PUSHED IN THE MIDDLE OF THE MICROCATHETER AND EXPERIENCED RESISTANCE. THE COIL WAS WITHDRAWN AND REPLACED WITH ANOTHER COIL OF THE SAME MODEL. ANOTHER COIL (APB-4-8-HX-ES) USED IN THE PROCEDURE HAD THE DISTAL PUSHWIRE STRETCHED AT THE TIP OF THE MICROCATHETER RESULTING IN THE COIL BEING WITHDRAWN. THERE WAS NO FRICTION OR REPOSITIONING, AND A CONTINUOUS FLUSH WAS NOT USED. 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, RUPTURED ANEURYSM WITH A MAX DIAMETER OF 9 MM AND A 6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE COIL PUSHED SMOOTHLY FROM THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356830 ↗

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