Axium Prime Detachable Coil System APB-3.5-6-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000313753), received between Sep 18, 2024 and Aug 22, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

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.

• MalfunctionAug 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE AT THE DISTAL END OF THE ECHELON 10 MICROCATHETER. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4.67MM AND THE NECK DIAMETER WAS 3.28MM. PATIENT'S BLOOD FLOW WAS NORMAL; VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER CONNECTING TO THE SYSTEM AND FULLY HYDRATING, THE AXIUM COIL WAS ADVANCED INTO THE ECHELON 10 MICROCATHETER. HOWEVER, RESISTANCE WAS FELT WITH THE COIL IN THE DISTAL END OF THE MICROCATHETER. THE SURGEON ATTEMPTED TO REDUCE TENSION IN THE MICROCATHETER TO CONTINUE COIL DELIVERY BUT IT DID NOT RESOLVE THE ISSUE. IT WAS THEN ALSO A STRUGGLE TO WITHDRAW THE COIL SMOOTHLY FROM THE MICROCATHETER. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874660 ↗
• MalfunctionJul 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE AND WAS STUCK IN THE SHEATH. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  THERE WAS NO PATIENT INVOLVEMENT. ANCILLARY DEVICES INCLUDE AN ECHELON MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH HAD BEEN ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512091 ↗
• MalfunctionSep 18, 2024Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 4MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE ANEURYSM EMBOLIZATION, AFTER THE MICROCATHETER WAS IN PLACE, AND THE APB-3.5-6-3D-ES WAS DELIVERED FOR FILLING. DURING THE ADJUSTMENT PROCESS, THE COIL WAS FOUND TO BE STRETCHED, SO IT WAS REMOVED AND REPLACED WITH A NEW COIL TO COMPLETE THE SURGERY. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN REPOSITIONED THE COIL 2 TIMES DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE AN ECHELON MICROCATHETER. ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249592 ↗