Axium PrimeTM FC-3-10-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536034075), received between Mar 10, 2022 and Mar 10, 2022 — classified as 1 malfunction.

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

• MalfunctionMar 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PRE-MATURELY DETACHED. THE COIL WAS REMOVED FROM THE PATIENT WITH A SNARE. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE ICA WITH A MAX DIAMETER OF 17-18MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS UNKNOWN AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE: ENVOY 6F GUIDE CATHETER, A SL-10 MICROCATHETER, A SYNCHRO GUIDEWIRE, AND A NEUROFORM STENT TARGET COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725795 ↗