Axium PrimeTM APB-2.5-8-HX-ESRecalls & reported problems
Micro Therapeutics, Inc. · COIL APB-2.5-8-HX-ES V04 · 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 00847536032248), received between Apr 13, 2022 and Apr 13, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Deformation1
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.
MalfunctionApr 13, 2022Break; Material Deformation; Break; Material Deformation
MEDTRONIC RECEIVED A REPORT THAT THE REBAR18 MICROCATHETER WAS PLACED IN THE M1 SEGMENT WITH GUIDANCE OF THE GUIDEWIRE IN PLACE. THEN THE ECHELON 10 WAS PLACED INTO THE ANEURYSM WITH THE GUIDANCE OF THE GUIDEWIRE. AN AXIUM WAS CHOSEN TO FORM A HOOP AND WAS WITH A HALF-DEPLOYED STENT. DURING THE DEPLOYMENT PROCESS, THE COIL MICROCATHETER WAS EJECTED FROM THE ANEURYSM CAVITY. THE STENT AND THE COIL WAS RETRIEVED. THE COIL WAS RE-USED FOR FORMING A HOOP. DURING THE COIL PUSHING PROCESS, ONLY THE COIL PUSH ROD COULD BE SEEN. THE COIL BODY WAS DISAPPEARED AT THE TIP OF THE DETACHMENT MARKER. THE PUSH ROD WAS PULLED OUT OF THE BODY AND IT WAS FOUND THAT THE MIDDLE AND FAR SECTION OF THE PUSH ROD HAD BEEN DISCONNECTED. THE COIL WAS NOT FOUND IN VIVO AND IT WAS FOUND THE COIL BODY HAD FALLEN OFF IN VITRO. THE COIL SEPARATED/BROKE/PREMATURELY DETACHED. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS BENT/BROKEN AND IT WAS NOT DONE ON PURPOSE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL AND THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CON
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14092809 ↗
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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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