Axium™ Prime Detachable Coil System APB-2.5-6-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000847227), received between Jan 9, 2026 and Mar 26, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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.

• MalfunctionMar 26, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME COIL HAD POOR DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE INSTANT DETACHER 3 TIMES, AND NO ATTEMPT WAS MADE TO WITHDRAW (DETACH) USING ANOTHER INSTANT DETACHER OR MANUALLY VIA THE HYPOTUBE. IT WAS REPORTED THAT THERE WERE NO DEFECTS WITH THE INSTANT DETACHER. THE COIL WAS REPLACED WITH A ANOTHER APB COIL TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS TREATED FOR TRANSVENOUS EMBOLIZATION FOR CAROTID-CAVERNOUS FISTULA LOCATED AT C AVERNOUS SINUS. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT OR INJURY ASSOCIATED WITH THIS EVENT AND REPORTED NO SYMPTOMS RELATED TO THE NON DETACHMENT. THE CAUSE OF THE NON DETACHMENT WAS NOT DETERMINED. NO ISSUES WERE ENCOUNTERED PRIOR TO THE COIL NON DETACHMENT, AND NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CORRECT QUANTITY OF COILS TO BE REPORTED WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700043 ↗
• MalfunctionJan 9, 2026Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. BEFORE THE NON-DETACHMENT, NO NOTICEABLE ISSUES HAD ARISEN. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. EMERGENCY DETACHMENT WAS PERFORMED SEVERAL TIMES, AND THE COIL WAS EVENTUALLY DETACHED AND REMAINED IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028085 ↗