Axium Prime Detachable Coil System APB-3.5-10-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000313777), received between Jul 1, 2025 and Jun 5, 2026 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS ENCOUNTERED RESISTANCE/WERE STUCK IN THE SHEATH. IT WAS REPORTED THAT THERE WAS A GRITTY FEEL WHILE PUSHING 1-2CM OF THE COILS INSIDE THE PLASTIC SHEATH INTRODUCER. THE COILS DID NOT COME OUT OF THE SHEATHS SMOOTHLY. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT WAS INVOLVED IN THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CONTRIBUTING FACTOR OF THE RESISTANCE WAS THAT THE DEVICE WAS STUCK ON THE PLASTIC COIL INTRODUCER. ADDITIONALLY, CONTINUOUS SALINE FLUSH WAS ADMINISTERED AS INDICATED IN THE IFU AND DURING PREPARATION THE INTRODUCER SHEATH WAS LAID HORIZONTALITY FLAT IN THE TABLE. ALL INFORMATION WAS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411448 ↗
• MalfunctionJul 1, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE DURING DELIVERY IN THE ECHELON 10 MICROCATHETER AND BECAME DAMAGED/STRETCHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILARY ARTERY APEX RUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4.2MM AND THE NECK DIAMETER WAS 3.6MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). DURING DELIVERY, THE AXIUM COIL WAS STUCK AT THE DISTAL SEGMENT OF THE ECHELON 10 MICROCATHETER. THE COIL WAS STRETCHED. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER. THE COIL WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED DURING THE PROCEDURE PER THE IFU. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22377237 ↗