Insufflator, Automatic Carbon-Dioxide For Endoscope
FDA adverse event reports and recall history for insufflator, automatic carbon-dioxide for endoscope (product code FCX), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 517
- Deaths
- 6
- Injuries
- 116
- Malfunctions
- 365
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-10-28TerminatedUse error
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.
- TerminatedNonconforming Material/Component
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Monitor insufflator, automatic carbon-dioxide for endoscope automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.