HIGH FLOW INSUFFLATION UNIT UHI-4 (REF N3829640)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,484 adverse event reports that list this exact device (DI 04953170324147), received between Sep 6, 2019 and Aug 7, 2026 — classified as 6 deaths, 56 injuries, 2,422 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (292 reports).

3 FDA recall records name this device's identifier, 3 still open.

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.

Recalls naming this device

1. Jun 16, 2026Open, Classified

   Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

   Z-2776-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Sep 25, 2023Open, Classified

   Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".

   Z-1375-2024 · Root cause: Process control · Recall details · FDA record ↗

3. Sep 22, 2023Open, Classified

   There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.

   Z-0075-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,484 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026No Display/Image

  It was reported that the high flow insufflation unit had the unit screen went black during a case. The issue was found during an unknown procedure. There were no reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50179803 ↗
• MalfunctionJul 17, 2026Break; Gas/Air Leak

  THE CUSTOMER RETURNED THE [COMMON DEVICE] TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE ENGINEER INDICATED THAT THE CO2 GAS CONNECTOR/INPUT (K-CONNECTOR) WAS LEAKING AND THE PINCH VALVE HAD BROKEN PLASTICS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25861124 ↗
• MalfunctionJul 15, 2026Key or Button Unresponsive/not Working

  THE CUSTOMER REPORTED THAT THE INSUFFLATOR WAS NOT WORKING, INVOLVING AN OLYMPUS HIGHT FLOW INSUFFLATION UNIT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25833746 ↗
• MalfunctionJun 24, 2026Gas/Air Leak

  THE CUSTOMER RETURNED THE HIGH FLOW INSUFFLATION UNIT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE ENGINEER INDICATED THAT A FAILED SECONDARY PIPING LEAKAGE MEASUREMENT, AND A FAULTY ELECTROPNEUMATIC PROPORTIONAL VALVE. IT WAS DETERMINED THAT THE CIRCUIT BOARD NEEDED TO BE REPLACED.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25616852 ↗
• MalfunctionJun 11, 2026Corroded

  IT WAS OBSERVED THAT DURING THE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT EXHIBITED THAT THE AIR/WATER/SUCTION INSUFFLATION TUBE HAS RUST. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480033 ↗
• MalfunctionJun 8, 2026Break; Crack

  THE CUSTOMER RETURNED THE HIGH FLOW INSUFFLATION UNIT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THE PLUG ON THE CABLE CONNECTING THE POWER SUPPLY AND THE CIRCUIT BOARD WAS FAULTY AND A CRACK WAS FOUND ON THE PINCH VALVE IN THE AIR/WATER/SUCTION SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425455 ↗
• MalfunctionJun 1, 2026Display or Visual Feedback Problem

  THE CUSTOMER RETURNED THE HIGH FLOW INSUFFLATION UNIT, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT ONE LED DISPLAY SEGMENT WAS NOT WORKING ON THE PRESSURE SENSOR DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348022 ↗
• MalfunctionMay 28, 2026Material Separation; Output Problem

  THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING EVALUATION OF THE DEVICE, IT WAS FOUND THAT THE POWER SWITCH HAD DISLOCATED FROM ORIGINAL POSITION AND IT HAD BECOME OBSOLETE AND LIGHTS ON DISPLAY APPEARED DARK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25320873 ↗
• MalfunctionMay 20, 2026Erratic or Intermittent Display

  IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE HIGH FLOW INSUFFLATOR FRONT PANEL WAS FAULTY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233425 ↗
• MalfunctionMay 18, 2026Naturally Worn

  IT WAS REPORTED, THE INSUFFLATION UNIT EXHIBITED THE CO2 HOSE ASSEMBLY WAS WORN. THE EVENT OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25202615 ↗
• MalfunctionApr 30, 2026Computer Software Problem; No Visual Prompts/Feedback

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT FRONT PANEL SEGMENT LIGHT EMITTING DIODE (LED) WAS BURNED OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048378 ↗
• MalfunctionMar 26, 2026Electrical /Electronic Property Problem; Gas/Air Leak

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT ELECTROPNEUMATIC PROPORTIONAL VALVE WAS FAULTY AND IT FAILED THE PRIMARY LEAKAGE TEST. ADDITIONALLY, THE PRINTED CIRCUIT BOARD WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700487 ↗
• MalfunctionMar 23, 2026Power Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662251 ↗
• MalfunctionMar 20, 2026Power Problem

  IT WAS REPORTED THE HIGH FLOW INSUFFLATION UNIT WAS NOT WORKING. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649872 ↗
• MalfunctionMar 16, 2026Electrical /Electronic Property Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT EXHIBITED DIMMER LIGHT EMITTING DIODE INDICATORS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606879 ↗
• MalfunctionMar 9, 2026Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT EXHIBITED A RUSTY INSUFFLATION TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547622 ↗
• MalfunctionMar 3, 2026Contamination; Gas Output Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT EXHIBITED BLACK OILY RESIDUE INSIDE THE TUBING ALONG THE PNEUMATIC PIPELINE AND THE MANIFOLD SYSTEM, AND NO FLOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497043 ↗
• MalfunctionMar 3, 2026Gas/Air Leak

  IT WAS REPORTED THE HIGH FLOW INSUFFLATION UNIT CARBON DIOXIDE DRAINS VERY FAST AND THERE IS A LEAK. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496451 ↗
• MalfunctionMar 2, 2026Break; Circuit Failure; Crack

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT FRONT PANEL LIGHT-EMITTING DIODES (LEDS) WERE DIMMER THEN INTENDED, THE FRONT PANEL NEEDED TO BE REPLACED, PRINTED CIRCUIT BOARD FAILURE NEEDED TO BE REPLACED, AND THE POWER SWITCH NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490780 ↗
• MalfunctionFeb 27, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THE HIGH FLOW INSUFFLATION UNIT THE CAVITY MODE IS ILLUMINATED AND FLASHES BETWEEN NORMAL AND SMALL. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469577 ↗
• MalfunctionFeb 25, 2026Circuit Failure

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT HAD A CIRCUIT BOARD FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442816 ↗
• MalfunctionFeb 24, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT EXHIBITED A DAMAGED SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428534 ↗
• MalfunctionFeb 23, 2026Increase in Pressure

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24419259 ↗
• MalfunctionFeb 19, 2026Failure to Power Up

  IT WAS REPORTED THE HIGH FLOW INSUFFLATION UNIT WAS NOT TURNING ON. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388339 ↗
• MalfunctionFeb 18, 2026Material Integrity Problem; Optical Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT DISPLAY HAS DIM LIGHT-EMITTING DIODE INDICATORS AND THE MECHANICAL SYSTEM HAS A FAULTY MANIFOLD UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377199 ↗