Versaflex 900004Recalls & reported problems
Given Imaging, Inc. · Disposable pH / Impedance Catheter, Single pH Sensor, 7 Impedance Rings, Pediatric, ZNIS+7R2.0 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260167483757), received between Mar 27, 2018 and Mar 27, 2018 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blood Loss1
- Cardiogenic Shock1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE PATIENT WAS (B)(6) YEAR OLD UNDERGONE AN EGD WITH PROPOFOL, THEY PLACED THE PATIENT TO SUPINE AND PLACED THE PH IMPEDANCE CATHETER. THEY WERE HAVING TROUBLE INTUBATING AND THEY MOVED BACK AND FORTH AND THERE WAS A SIGNIFICANT AMOUNT OF NASAL BLEEDING THAT HAPPENED AND THE PATIENT ALSO HAD LARYNGOSPASM AND THE PH LEVEL DROPPED TO 15% BELOW BASELINE CAUSING THEM TO OPEN THE CRASH CART AND BEGUN BAGGING THE PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: Blood Loss; Cardiogenic Shock
MAUDE report 7375791 ↗
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- Bravo FGS-0634Given Imaging, Inc. · Electrode, pH, stomach15 reports
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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 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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