Digitrapper 800004Recalls & reported problems
Given Imaging, Inc. · recorder, pH-Z · Class 1
Data updated Oct 13, 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 07290101362906), received between Jun 18, 2025 and May 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Overheating of 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device2
- Failure to Power Up1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Overheating of Device; Failure to Power Up
IT WAS REPORTED THAT THE RECORDER HAD OVERHEATED AND THE RECORDER WOULD NOT POWER ON WHEN UPLOADING THE STUDY. THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172586 ↗MalfunctionJun 18, 2025Overheating of Device; Smoking; Overheating of Device; Smoking
IT WAS REPORTED BY THE PATIENT THAT THE RECORDER BECAME HOT AND STARTED SMOKING. THERE WERE NO FLAMES SEEN. THE PATIENT THEN PULLED THE CATHETER OUT FROM THE NARES AND REMOVED THE RECORDER FROM THE VICINITY AND AT SOME POINT, SWITCHED THE BATTERIES AROUND SO IT WOULD NOT CATCH ON FIRE WHILE IT WAS TRANSPORTED TO THE HOSPITAL. THE SCREEN OF THE RECORDER COULD NO LONGER BE SEEN. THE PATIENT'S NOSE AND STOMACH WERE BLEEDING. HAD ONE EPISODE OF EPISTAXIS IN THE EVENING OF THE TEST, AND HAD ONGOING STOMACH ISSUES BUT THESE WERE CHRONIC AND UNRELATED TO THE PH TEST. A BLEEDING ON THE NOSE OCCURRED PRIOR THE PROCEDURE OR HOURS BEFORE THE RECORDER MALFUNCTIONED. THE PATIENT APPLIED PRESSURE ON THE NOSE AND IT STOPPED WITHIN 10 MINUTES. THERE WAS LIKELY NO BLEEDING IN THE STOMACH. THE PATIENT HAVE ADHD (ATTENTION-DEFICIT/HYPERACTIVITY DISORDER) AND HAD DIFFICULTY ACCURATELY DESCRIBING SOME SYMPTOMS AND HAD ISSUES WITH CONCENTRATING ON THE QUESTIONS ASKED. DIRECT ANSWERS TO QUESTIONS WERE NOT ALWAYS PROVIDED AND OTHER UNRELATED ISSUES WERE CONSISTENTLY BROUGHT UP IN THE CONVERSATION AND FIXATED UPON. THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22284186 ↗
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
- Versaflex 957970Given 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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