Axium PrimeTM FC-5-10-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536034174), received between Sep 22, 2021 and Jul 27, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT TWO COILS PREMATURELY DETACHED IN THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ICA. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S BLOOD FLOW WAS HIGH, AND THEIR VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE HAD BEEN NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED WITH THE FIRST COIL, BUT NOT THE SECOND. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A HEADWAY 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118014 ↗
• MalfunctionDec 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT AN AXIUM FRAMING COIL DETACHED PREMATURELY. IT WAS NOTED THAT THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID REPOSITION THE COIL 3 TIMES BUT DID NOT ROTATE THE PUSHWIRE OR ATTEMPT TO DETACH THE COIL. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS REMOVED FROM THE PATIENT AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6.34MM AND THE NECK DIAMETER WAS 3.65MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908420 ↗
• MalfunctionSep 22, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO PROBLEMS PRIOR TO THE NON-DETACHMENT, AND NO DAMAGE WAS OBSERVED TO THE PUSHWIRE WAS OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512272 ↗