Axium PrimeTM FC-14-40-3DRecalls & reported problems
Micro Therapeutics, Inc. · COIL FC-14-40-3D V03 · Class 2 · Implant
All models of Axium PrimeTM (66)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536034402), received between Dec 12, 2020 and Mar 25, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (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
- Packaging Problem1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2022Packaging Problem; Packaging Problem
MEDTRONIC RECEIVED A REPORT THAT THE FRAMING COIL DELIVERY WIRE WAS BROKEN AND SEPARATED AT THE PROXIMAL END DETACHMENT SITE. THE STERILE PACKAGING WAS ALREADY OPENED. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13905250 ↗MalfunctionDec 12, 2020Stretched; Stretched
MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL STRETCHED UPON REMOVAL. THE PATIENT WAS UNDERGOING SURGERY FOR COIL EMBOLIZATION AND THEN THE COIL WAS USED FOR THE SACRIFICE OF RUPTURED MIDDLE CEREBRAL ARTERY TO CONTROL SUBARACHNOID HEMORRHAGE.. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE PHYSICIAN HAD ATTEMPTED TO PLACE THE FC-14-40-3D AXIUM PRIME COIL IN THE EXTRAVASCULAR SPACE. IT WAS DECIDED THIS COIL WAS TOO LARGE, AND WHEN PULLING THE COIL BACK INTO THE SL-10 MICROCATHETER, THE COIL STRETCHED IN THE MIDDLE. THE COIL WAS ABLE TO COMPLETELY REMOVE THIS COIL WITHOUT INCIDENT. THERE WAS NO FRICTION AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. ANCILLARY DEVICES INCLUDE A MICROVENTION SOFIA, STRYKER SL-10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10995707 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
- POD RBYPODJ60-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page