Uniblate 700-103530Recalls & reported problems
Navilyst Medical, Inc. · RITA UniBlate Electrosurgical Device · Class 2
Data updated Oct 16, 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 H7877001035301), received between Jan 6, 2020 and Jan 6, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Problem” (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 16, 2026.
Most reported problems
Device problems
- Activation Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2020Activation Problem; Activation Problem
AS REPORTED: "OP" SHOWED UP ON TEMPERATURE WINDOW 1 AND 4 , AND "OL" SHOWED UP ON WINDOW 5 AND COULDN'T START ABLATION. THE PROCEDURE COULD NOT BE COMPLETED, AND THE PATIENT HAD BEEN SEDATED AT THE TIME OF THE EVENT. THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY DUE TO PATIENT SAFETY RISK OF UNNECESSARY SEDATION. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9554735 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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