Axium PrimeTM FC-8-30-3DRecalls & reported problems
Micro Therapeutics, Inc. · COIL FC-8-30-3D V03 · Class 2 · Implant
All models of Axium PrimeTM (66)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 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 00847536034303), received between Jun 7, 2022 and Jun 7, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
MalfunctionJun 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS UNINTENTIONALLY PREMATURELY DETACHED. NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS REQUIRED AS THE COIL WAS REMOVED WITH THE MICROCATHETER. THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE COIL WAS NOT REPOSITIONED, THE DELIVERY PUSHER WAS NOT ROTATED, AND NO DETACHMENT ATTEMPTS WERE MADE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT POSTERIOR COMMUNICATING ARTERY. THE PA TIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14620306 ↗
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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.
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