Ultra Vac E-Z Clean 211010ECRecalls & reported problems
I.C. Medical, Inc. · ICM-000-0482 · 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 00817688022244), received between Feb 11, 2020 and Feb 11, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2020Defective Device
A. BOVIE MADE NO NOISE, WOULD NOT WORK SO A NEW BOVIE WAS OPENED AND WORKED FINE. B. BOVIE DID NOT FUNCTION PROPERLY- ONLY THE CUT BUTTON WORKED WHEN PRESSED AND THE COAG BUTTON DID NOT WORK AT ALL. (NO AFFECTED PATIENT). C AND D. BOVIES WOULD NOT WORK WHEN PLUGGED INTO BOVIE MACHINE - BUTTONS WOULD NOT WORK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9693570 ↗MalfunctionFeb 11, 2020Defective Device
DURING RIGHT L4 AND L5 FORAMINOTOMY, THE BOVIE MADE NO NOISE AND WOULD NOT WORK IN ANY WAY. IT WAS EXCHANGED OUT FOR A NEW ONE WHICH WORKED FINE. NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9693461 ↗
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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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