Versaflex 957970Recalls & reported problems
Given Imaging, Inc. · Disposable pH Catheter, Single Sensor, VNIS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260167483931), received between Oct 21, 2019 and Nov 14, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
Patient problems
- Discomfort1
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
- Radiation Exposure, Unintended1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE CALIBRATION AND OTHER PRE-SEQUENCE OPERATIONS OF THE CATHETER WERE NORMAL. AFTER THE CATHETER WAS PLACED, THE PATIENT WAS UNCOMFORTABLE. THE PATIENT DID NOT BITE THE CATHETER. THE OPERATOR WAS CAREFUL DURING THE OPERATION AND DID NOT SEE THE CATHETER ENTER THE ORAL CAVITY. THE ELECTRODE WAS REMOVED AND THE TIP OF THE ELECTRODE WAS FOUND TO BE BROKEN. THE BROKEN TIP OF THE ELECTRODE WAS INSIDE THE PATIENT'S BODY. THE BREAK WAS SHARP. AT THE SAME TIME, BLOOD WAS FOUND ON THE SURFACE OF THE ELECTRODE. IT PASSED THROUGH THE NASAL CAVITY TO THE STOMACH AND THE BLEEDING WAS WITHIN THIS RANGE. NO GASTROSCOPY WAS DONE, AND THERE WAS NO SPECIFIC BLEEDING SITE. THE EVENT LEAD TO OR EXTEND PATIENT HOSPITALIZATION.
Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding
MAUDE report 20683768 ↗InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING INTUBATION, THE CUSTOMER PULLED THE CATHETER UP AT 8 CM FROM THE NARES AND IT WAS STUCK. THE NURSE THEN REMOVED THE CATHETER FROM THE PATIENT, AND THE TIP OF THE CATHETER WAS LEFT INSIDE THE PATIENT. THE FRAGMENT TIP WAS NOT EXPELLED BY THE PATIENT AND IT WAS NOT RECOVERED. PATIENT DID NOT EXPERIENCED BLEEDING DUE TO THE INCIDENT. CT SCAN WAS PERFORMED.
Patient problems: Foreign Body In Patient; Radiation Exposure, Unintended
MAUDE report 9216648 ↗
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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