AxiumTM APB-6-10-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536008250), received between Mar 24, 2019 and Mar 23, 2022 — classified as 3 malfunctions.

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

• MalfunctionMar 23, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A AXIUM COIL COULD NOT BE DETACHED. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM IN THE ANTERIOR CEREBRAL ARTERY (ACA). THE MAX DIAMETER WAS 6.52MM AND THE NECK DIAMETER WAS 4.37MM. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  COIL COULD NOT BE DETACHED SO THE PHYSICIAN PULL OUT THE MICROCATHETER. PHYSICIAN RE-ACCESSED THE VESSEL AND PLACED ANOTHER COILS. OTHER COILS WERE SUCCESSFULLY DETACHED. THE PHYSICIAN TRIED TO DETACH THE COIL WITH THE INSTANT DETACHER SEVERAL TIMES. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. NO SYMPTOMS WERE REPORTED.  ANCILLARY DEVICES: XL 1O MICORCATHETER, ASAHI CHIKAI BLACK GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866771 ↗
• MalfunctionFeb 23, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED WITHIN THE MICROCATHETER AFTER FAILED DETACHMENT ATTEMPTS DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION TREATMENT FOR A RUPTURED SACCULAR ANEURYSM OF THE POSTERIOR INTERNAL CAROTID ARTERY (PICA). THE ANEURYSM MAX DIAMETER WAS 6.1MM AND THE NECK DIAMETER WAS 4.3MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS IN PLACE WELL INSIDE THE ANEURYSM. THE COMPLAINT AXIUM COIL WAS THE FIRST COIL USED. THE PHYSICIAN FLUSHED THE COIL SLEEVE PER IFU BY PUTTING THE COIL SLEEVE HALF INTO THE Y CONNECTOR AND ALLOWING THE SALINE TO FLUSHED THROUGH THE COIL SLEEVE. THE COIL WAS THEN INSERTED THROUGH THE MICROCATHETER HUB AND THE RHV WAS TIGHTENED PER IFU. THE COIL WAS PLACED INSIDE THE ANEURYSM AND SLOWLY PUSHED FORWARD. WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, IT COULD NOT BE DETACHED. 3 ATTEMPTS WERE MADE WITH ONE INSTANT DETACHER WITHOUT SUCCESS. A SECOND INSTANT DETACHER WAS THEN TRIED TWICE WITHOUT SUCCESS. 1 ATTEMPT WAS MADE TO DETACH THE COIL MANUALLY WITH THE HYPOTUBE BUT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365769 ↗
• MalfunctionMar 24, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THIS COIL WOULD NOT DETACH WITH AN INSTANT DETACHER OR USING MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE). THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR ASMALL RUPTURED SACCULAR ANEURYSM LOCATED IN LEFT MIDDLE ANTERIOR COMMUNICATING ARTERY ANEURYSM, MEASURING 6.5MMX2.2MM. THE VESSEL WAS NORMAL TORTUOUS. IT WAS REPORTED THAT THE PHYSICIAN TOOK APB-6-10-3D-SS AS FIRST COIL AND DEPLOYED COMPLETELY IN THE ANEURYSM. BUT WHEN HE TRIED TO DETACH IT, IT WAS NOT GETTING DETACHED. THE PHYSICIAN ATTEMPTED TWO TIMES WITH ONE INSTANT DETACHER, ONE TIME WITH SECOND DETACHER AND ONE TIME TRIED MANUAL DETACHMENT TO DETACH THE COIL, BUT COIL DID NOT DETACH. SO, HAD TO TAKE OUT THIS COIL <(>&<)> TOOK OTHER COILS TO FINISH THE PROCEDURE. USED THE SAME INSTANT DETACHER TO DETACH OTHER COILS ALSO <(>&<)> IT WORKED PROPERLY. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES ARE AVAILABLE FOR REVIEW. NO PATIENT INJURY WAS REPORTED. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8446828 ↗

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