Halyard LAKC014-07_0004Recalls & reported problems
Avid Medical, Inc. · Class 2
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 10809160313060), received between May 26, 2021 and May 26, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective 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
- Defective Component1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2021Defective Component; Defective Component
THE CUSTOMER REPORTED ITEM # (B)(4) PENCIL SMOKE EVAC PUSH BUTTON CAUGHT FIRE, EXPLODED AND BURNED THE SURGEON. NO PATIENT INJURY WAS REPORTED. THE SURGEON¿S HAND WAS BURNED. AS OF 05/11/2021, STILL NO WORD FROM HOSPITAL ON STATEMENT FOR EXACT TREATMENT THAT WAS PERFORMED FOLLOWING THE SURGEON¿S HAND GETTING BURNED. NO PATIENT INJURY WAS REPORTED.
Patient problems: Burn(s)
MAUDE report 11886394 ↗
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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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