Axium Prime Detachable Coil System APB-2-2-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000313869), received between Dec 4, 2023 and May 5, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMay 5, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE IN THE SHEATH AND CATHETER HUB AND PROXIMAL SECTION. IT WAS REPORTED THAT THE COIL DID NOT PASS THROUGH THE MICROCATHETER HUB. THE CATHETER AND COIL WERE NOT DAMAGED. 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. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER RESISTANCE OCCURRED AT THE HUB. THERE WAS NO RESISTANCE IN THE SHEATH. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION BECAUSE THE COIL DIDN'T EVEN GET PAST THE MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED. THE CATHETER WAS A MEDTRONIC PRODUCT (ECHELON). BEFORE ATTEMPTING TO INSERT INTO THE MICROCATHETER DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO KINK/DAMAGE TO THE COIL OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088466 ↗
• MalfunctionApr 5, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT DURING PREPARATION OF THE COIL PER THE INSTRUCTIONS FOR USE (IFU), THE COIL PREMATURELY SEPARATED FROM THE PUSHWIRE. IT WAS NOTED THERE HAD BEEN FRICTION OR OTHER DIFFICULT PRIOR TO THE SEPARATION. THE PUSHWIRE WAS NOT BENT OR BROKEN AND THE PHYSICIAN DID NOT ROTATE THE PUSHWIRE. NO ATTEMPT HAD BEEN MADE TO DETACH THE COIL. AS THE EVENT OCCURRED DURING PREPARATION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052837 ↗
• MalfunctionDec 4, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE COIL DETACHED OUTSIDE AND WAS DISCARDED. THERE WERE NO DETACHMENT ATTEMPTS BECAUSE THE COIL WAS PRE-DETACHED DUE TO THE WIRE BEING FOLDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18260953 ↗