Axium™ Prime Detachable Coil System FC-3-6-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000847371), received between Jul 1, 2025 and Sep 4, 2025 — classified as 2 malfunctions.

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

• MalfunctionSep 4, 2025Break; Break

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME FRAMING COIL WAS REMOVED FROM THE SHEATH AND WAS CHECKED BEFORE INSERTING THE DEVICE INTO THE MICROCATHETER. WHEN PULLING IT BACK TO THE SHEATH, A LITTLE RESISTANCE WAS FELT AND IT WAS OBSERVED THAT THERE WAS A BROKEN PORTION. THERE WAS NO DEFORMATION OR DAMAGE IN THE DELIVERY PUSHER. THERE WAS NO RESISTANCE DURING DELIVERY, THE COIL WAS NOT REPOSITIONED, COIL DISLODGEMENT WAS NOT ATTEMPTED, AND THE DELIVERY PUSHER DID NOT ROTATE INSIDE THE PATIENT'S BODY. THE COIL WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS FLUSHED CONTINUOUSLY DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967700 ↗
• MalfunctionJul 1, 2025Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE TECHNICIAN STATED THAT WHILE THEY WERE ADVANCING THE COIL INTO THE MICROCATHETER, THE PUSHWIRE APPEARED TO BREAK JUST PROXIMAL TO THE MANUAL BREAK POINT. THE COIL WAS REMOVED WITHOUT INCIDENT AND REPLACED WITH ANOTHER AXIUM 3X6 FRAMING COIL. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE NOT PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) AS THE COIL WAS FLUSHED ON THE BACK TABLE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED LEFT SUPERIOR HYPOPHYSEAL ANEURYSM WITH A MAX DIAMETER OF 4.9MM AND A 3.6MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. PATIENT WAS NOTED TO HAVE HAD A PREVIOUSLY RUPTURED ANEURYSM, WHICH WAS COILED. ANCILLARY DEVICES INCLUDE A BMX 96, LOT: H00006023 GUIDE CATHETER, PHENOM 17, LOT: 230932591 MICROCATHETER, TRAXCESS 14, LOT: 250220 GUIDEWIRE, AND APRO 55IC, LOT: NV24-020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373393 ↗