Axium™ Prime Detachable Coil System APB-2-8-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000847197), received between May 27, 2026 and May 27, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR LUMBAR EPIDURAL MASS. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL WOULD NOT DETACH, EVEN THOUGH THE SAME INSTANT DETACHER WAS SUCCESSFULLY USED WITH OTHER AXIUM COILS. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DETACH THE COIL USING THE INSTANT DETACHER BUT DID NOT TRY USING ANOTHER DETACHER. MANUAL DETACHMENT VIA THE HYPOTUBE WAS ALSO ATTEMPTED MULTIPLE TIMES. THERE WERE NO REPORTED ISSUES WITH THE INSTANT DETACHER ITSELF. 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 STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25310896 ↗