CO2MPACT 710300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00724995180362), received between Oct 25, 2022 and Aug 28, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR CO2EFFICIENT ENDOSCOPIC INSUFFLATOR WAS NOT OPERATING PROPERLY AND SUBSEQUENTLY CAUSED "HARM" TO THE PATIENT. THE USER FACILITY DECLINED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22912729 ↗
• MalfunctionJul 18, 2025Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR CO2 EFFICIENT ENDOSCOPIC INSUFFLATOR SYSTEM WAS INTERMITTENTLY SHUTTING OFF RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541037 ↗
• MalfunctionOct 25, 2022Insufficient Device Problem Information; Activation Problem; Insufficient Device Problem Information; Activation Problem

  THE USER FACILITY REPORTED THAT THEIR CO2MPACT ENDOSCOPIC INSUFFLATOR ENTIRE PANEL IS TURNED ON WITH LIGHTS AT THE HALF FLOW RESULTING IN A PROCEDURE DELAY. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670858 ↗
• MalfunctionOct 25, 2022Insufficient Device Problem Information; Activation Problem; Insufficient Device Problem Information; Activation Problem

  THE USER FACILITY REPORTED THAT THEIR CO2MPACT ENDOSCOPIC INSUFFLATOR FRONT PANEL IS NOT FUNCTIONING PROPERLY RESULTING IN A PROCEDURE DELAY. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670646 ↗