NA GS2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20845854045395), received between Nov 15, 2022 and May 15, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMay 15, 2025Increase in Pressure; Increase in Pressure

  ON 03/06/2025 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT, "GS2000 INSUFFLATOR WAS BEING USED, AND C02 PRESSURE COULD NOT BE REGULATED PROPERLY AND CAUSING OVER PRESSURE TO THE PATIENT." THAT OCCURED ON (B)(6) 2025 IN AUSTRALIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027329 ↗
• MalfunctionMar 26, 2024Gas Output Problem; Protective Measures Problem; Gas Output Problem; Protective Measures Problem

  ON 1/17/2024, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING ALLEGED ISSUES "CUSTOMER COMMENTS CONFIRMED, ADDITIONAL ISSUES FOUND; PRESSURE SET, CPS MAINTAINS INDICATOR, OVERPRESSURE AND RESTRICTION INDICATOR NOT FUNCTIONING. THE FRONT BOTTOM RIGHT-HAND CORNER IS CHIPPED." DESPITE REQUESTS FOR WHAT "CUSTOMER COMMENTS" WAS REFERRING TO NO FURTHER INFORMATION TO DATE HAS BEEN RECEIVED. THE DEVICE WAS EVALUATED BY NORTHGATE ON 02/26/2024 WHERE IT WAS FOUND THAT THE MAIN PORT MECHANICAL SAFETY RELIEF VALVE TUBING WAS DISCONNECTED FROM THE MANIFOLD BARBED FITTING AND THE MAIN PORT MECHANICAL SAFETY RELIEF VALVE LOOSE IN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979644 ↗
• InjuryNov 1, 2023Increase in Pressure; Increase in Pressure

  ON 02OCT2023 NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING ALLEGED EVENT " THE PATIENT WAS INJURED HOWEVER HOSPITAL CONTACT WOULD NOT PROVIDE SPECIFICS." "DEVICE MONITOR DISPLAYED -9MMHG HOWEVER THE PATIENT WAS CLEARLY HYPER-DISTENDED. PROCEDURE STOPPED AND THE DEVICE WAS RESET [?][?][?][?]THE SAME ISSUE HAPPENED AGAIN. THEATRE TECH SWAPPED OUT THE UNIT FOR ANOTHER GS2000 HOWEVER THIS DIDN'T OPERATE CORRECTLY EITHER [REDACTED HOSPITAL CONTACT] BELIEVES THIS MAY HAVE BEEN DUE TO INCORRECT SETUP OF GAS SUPPLY BUT WILL BE RETURNING [THE DEVICE] FOR INSPECTION REGARDLESS." THE EVENT OCCURRED IN AUSTRALIA.

  Patient problems: Abdominal Distention; Insufficient Information

  MAUDE report 18051936 ↗
• InjuryNov 15, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE GS2000, 50L ABDOMINAL INSUFFLATOR, WAS BEING USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿THE EQUIPMENT HAS A FAULT WITH THE PRESSURES AND FLOWS SHOWING VALUES THAT DO NOT CORRESPOND AND HIGH INSUFFLATION FLOWS PRESENTING SEVERAL CASES OF INTRA-ABDOMINAL HYPERTENSION WITH HEMODYNAMIC CHANGE IN PATIENTS. WITH THE INCREASE IN CO2, PATIENTS HAVE DEVELOPED EMPHYSEMA, SEVERE HYPERCAPNIA. THE FLOW RATE ESTABLISHED IN THE EQUIPMENT IS 30 L/MIN., THE EQUIPMENT DOES NOT ALARM DESPITE THE FACT THAT THE DELIVERY OF THIS FLOW IS GREATER, IT PRESENTS PRESSURE REGULATION FAILURE.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE PROCEDURE WAS COMPLETED, WITH THE USE OF AN ALTERNATE DEVICE AND A 40-MINUTE DELAY. THE PATIENT STATUS WAS REPORTED AS ¿HOSPITALIZED IN INTENSIVE CARE UNIT.¿ THERE WAS NO REPORT OF SURGICAL INTERVENTION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO PATIENT DEVELOPING EMPHYSEMA AND HYPERCAPNIA WHICH LET TO EXTENDED HOSPITALIZATION IN THE INTENSIVE CARE UNIT.

  Patient problems: Pulmonary Emphysema

  MAUDE report 15798129 ↗