Reflux FGS-0656Recalls & reported problems
Given Imaging, Inc. · Reflux software v6.1 · Class 1
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 07290110360429), received between May 7, 2019 and May 7, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “High pH” (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
- High pH1
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.
MalfunctionMay 7, 2019High pH; High pH
ACCORDING TO THE REPORTER, THE STUDY HAD MULTIPLE EXCLUSIONS DUE TO HIGH PH. A REPEAT PROCEDURE WAS PERFORMED ON A DIFFERENT DAY. THE RECORDER AND WORK STATION SOFTWARE WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8586493 ↗
Other Electrode, pH, stomach devices
- Bravo FGS-0635Given Imaging, Inc. · Electrode, pH, stomach2 recalls1,621 reports
- Bravo FGS-0313Given Imaging, Inc. · Electrode, pH, stomach1,103 reports
- Bravo FGS-0636Given Imaging, Inc. · Electrode, Ph, Stomach2 recalls820 reports
- Bravo FGS-0312Given Imaging, Inc. · Electrode, pH, stomach125 reports
- Bravo FGS-0450Given Imaging, Inc. · Electrode, pH, stomach77 reports
- Bravo FGS-0634Given Imaging, Inc. · Electrode, pH, stomach15 reports
- Bravo RFB-0450Given Imaging, Inc. · Electrode, pH, stomach3 reports
- Digitrapper 800004Given Imaging, Inc. · Electrode, pH, stomach2 reports
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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