LAMIS 16ga x 15cm Infiltration Cannula BN1606Recalls & reported problems
Mentor Texas L.P. · LAMIS 16ga x 15cm Infiltration Cannula · Class 2
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 00081317022565), received between Jan 13, 2020 and Aug 27, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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
- Fluid/Blood Leak2
Patient problems
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A LAMIS 16GA X 15CM INFILTRATION CANNULA WAS FOUND TO BE LEAKING AT THE HUB BY THE END USER. THE DEVICE WAS NOT IN USE AT THE TIME, AND THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10459799 ↗MalfunctionJan 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CANNULA WAS LEAKING FLUID. THERE WAS NO ADVERSE EVENT OR PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 9583560 ↗
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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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