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Axium Prime Detachable Coil System FC-5-20-3DRecalls & reported problems

Micro Therapeutics, Inc. · COIL FC-5-20-3D V05 · Class 2 · Implant

All models of Axium Prime Detachable Coil System (70)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536038752), received between Aug 14, 2023 and Aug 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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

Device problems

  • Difficult or Delayed Positioning1
  • Physical Resistance/Sticking1
  • Separation Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 14, 2023Difficult or Delayed Positioning; Separation Failure; Physical Resistance/Sticking; Difficult or Delayed Positioning; Separation Failure; Physical Resistance/Sticking

    (B)(6) 2023 MPXR 1087249 (REP, HCP, FOR): MEDTRONIC RECEIVED A REPORT THAT THE HEALTHCARE PROVIDER (HCP) WAS PERFORMING INTRASACCULAR EMBOLIZATION ON THE UNRUPTURED SACCULAR ANEURYSM OF THE C7 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. IN ROUTINE OPERATION, THE MICRO-GUIDE WIRE WAS USED TO GUIDE THE MICRO-CATHETER INTO THE ANEURYSM, AND FC-5-20-3D WAS USED TO FORM A HOOP. THE FIRST HALF OF THE COIL WAS PERFECTLY FORMED A HOOP. WHEN THERE WAS ABOUT 3CM LEFT IN THE END, THE SURGEON PREPARED TO RECOVER PART OF THE COIL FOR ADJUSTMENT AND CONTINUED TO FILL THE COIL, AND THEN WHEN FILLING THE LAST FEW MILLIMETERS, THE TENSION WAS VERY LARGE, THE MICROCATHETER WAS PUSHED OUT OF THE TUMOR CAVITY, AND PUSHED THE FRONT MICROCATHETER TO SEND THE COIL INTO THE TUMOR CAVITY FOR DETACHMENT. WHEN THE GUIDE WIRE WAS WITHDRAWN, IT WAS FOUND THAT IT WAS NOT DETACHED COMPLETELY, THE COIL BODY WAS BROUGHT INTO THE MICROCATHETER ABOUT 3MM, AND THE COIL BODY COULD NOT BE SENT INTO THE TUMOR CAVITY BY PUSHING THE GUIDE WIRE. THERE WAS DIFFICULT PLACEMENT. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE VESSEL WAS NOT DAMAGED. THE TIP OF THE CATHETER WAS

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17540944 ↗

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Sources and updates

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