Axium PrimeTM FC-3-6-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536034051), received between Nov 17, 2021 and Mar 29, 2024 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE COILS FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED A2/PERICALLOSAL ANEURYSM WITH A MAX DIAMETER OF 3.2MM AND A 2.9MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT COMPLEX STENT COIL, DISTAL ANATOMY THAT DID WAS NOT AMENABLE TO DUAL MICROCATHETER PLACEMENT. ATLAS STENT WAS DEPLOYED WITH NO COMPLICATION. DUE TO 1 MICROCATHETER BEING USED, THEY HAD TO RE-ACCESS THE ANEURYSM THROUGH THE STENT (NOT UNCOMMON). THEY ENCOUNTERED SOME RESISTANCE ON THE PROXIMAL TINES OF THE STENT WITH THE MICROCATHETER (017 MC, 014 WIRE). THE STENT DID SLIGHTLY MIGRATE PROXIMAL TO DISTAL BUT NOTHING THAT PREVENTED FROM CONTINUING. THEY CONTINUED TO HAVE DIFFICULTY GETTING THROUGH THE STENT TO THE ANEURYSM WITH MULTIPLE ATTEMPTS. ONCE THEY DID GET ACCESS, THE MICROCATHETER TIP WAS IN THE SMALLER OF THE 2 LOBES OF THE ANEURYSM. TRIED TO DEVIATE BUT THE MICROCATHETER HAD A WEIRD SHAPE. THE DECISION TO DELIVER THE FIRST COIL WAS MADE. THE FIRST COIL 3.5 X 6 FRAME WAS ABLE TO FORM PROPERLY AND FILL IN SPACES THAT THEY WANTED. THE DETACHER WAS USED PER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004275 ↗
• MalfunctionNov 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PREMATURELY DETACHED WHILE COILING THE ANEURYSM. A FC 3X6 COIL WAS BEING REPOSITIONED AND THE COIL DETACHED. ABOUT 4CM OF THE COIL WAS IN THE XT-17 MICROCATHETER. THE PHYSICIAN PULLED (B)(6) ON TEH MICROCATHETER AND PULLED OUT THE MICROCATHETER WITH THE COIL INSIDE. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL FOUR TIMES. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED PERICALLOSAL ANEURYSM WITH A MAX DIAMETER OF 3.5MM AND A 3.4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICES INCLUDE A STRYKER XT-17 MICROCATHETER AND A SYNCHRO SELECT SOFT GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833505 ↗