Axium™ Prime Detachable Coil System FC-7-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000847586), received between Jan 9, 2026 and Jan 9, 2026 — classified as 2 malfunctions.

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

• MalfunctionJan 9, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE 3 AXIUM COILS COULD NOT BE DETACHED AN ANOTHER COIL BECAME STUCK IN THE PHENOM 17 MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SPINDLE-SHAPED ANEURYSM LOCATED IN THE BA-TOP. THE MAX DIAMETER WAS 10MM, AND THE NECK DIAMETER WAS 7MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT DETACHMENT FAILURE OCCURRED WITH THE THIRD COIL EMBOLIZATION. THREE COILS EXPERIENCED NON-DETACHMENT. DETACHMENT WAS ATTEMPTED 5 TO 6 TIMES BUT WAS UNSUCCESSFUL. SUBSEQUENTLY, DETACHMENT WAS SUCCESSFUL AFTER SWITCHING TO A DIFFERENT DETACHER. THE FINAL COIL BECAME STUCK AND COULD NOT BE DELIVERED. FLUSHING WAS ATTEMPTED, BUT THE ISSUE WAS NOT RESOLVED. USE OF A DIFFERENT PRODUCT RESULTED IN NO PROBLEMS. THE RESISTANCE WAS IN THE PROXIMAL PART OF THE CATHETER. THE COIL HAD PUSHED OUT SMOOTHLY FROM THE INTRODUCER SHEATH. THERE WAS NO DAMAGE TO THE COIL OR CATHETER. THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A SOFIA 6FR GUIDE CATHETER AND CHICANE NEXUS GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028180 ↗
• MalfunctionJan 9, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE 3 AXIUM COILS COULD NOT BE DETACHED AN ANOTHER COIL BECAME STUCK IN THE PHENOM 17 MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SPINDLE-SHAPED ANEURYSM LOCATED IN THE BA-TOP. THE MAX DIAMETER WAS 10MM, AND THE NECK DIAMETER WAS 7MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT DETACHMENT FAILURE OCCURRED WITH THE THIRD COIL EMBOLIZATION. THREE COILS EXPERIENCED NON-DETACHMENT. DETACHMENT WAS ATTEMPTED 5 TO 6 TIMES BUT WAS UNSUCCESSFUL. SUBSEQUENTLY, DETACHMENT WAS SUCCESSFUL AFTER SWITCHING TO A DIFFERENT DETACHER. THE FINAL COIL BECAME STUCK AND COULD NOT BE DELIVERED. FLUSHING WAS ATTEMPTED, BUT THE ISSUE WAS NOT RESOLVED. USE OF A DIFFERENT PRODUCT RESULTED IN NO PROBLEMS. THE RESISTANCE WAS IN THE PROXIMAL PART OF THE CATHETER. THE COIL HAD PUSHED OUT SMOOTHLY FROM THE INTRODUCER SHEATH. THERE WAS NO DAMAGE TO THE COIL OR CATHETER. THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A SOFIA 6FR GUIDE CATHETER AND CHICANE NEXUS GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028151 ↗