Trevo 80051Recalls & reported problems
Stryker Corporation · Trevo XP Provue System
All models of Trevo (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815742000511), received between Oct 3, 2019 and Oct 3, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Recalls naming this device
- Apr 23, 2024Open, Classified
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Z-1902-2024 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2019Break; Fracture; Break; Fracture
IT WAS REPORTED THAT WHEN THE SUBJECT DEVICE (RETRIEVER) WAS IN THE M2 SEGMENT FOR APPROXIMATELY 4 MINUTES; THE PHYSICIAN RETRACTED THE RETRIEVER 3/4 OF THE WAY INTO THE CATHETER; THE RETRIEVER BROKE OFF AND IT WAS WEDGED IN THE CATHETER. THE PHYSICIAN WAS ABLE TO PULL CATHETER OUT WITH THE RETRIEVER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9154014 ↗
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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