HIGH FLOW INSUFFLATION UNITRecalls & reported problems across all models

We found 4 models of HIGH FLOW INSUFFLATION UNIT by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 2,703 adverse event reports in the FDA's MAUDE database, received between Sep 18, 2018 and Aug 11, 2026 — classified as 6 deaths, 61 injuries, 2,636 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (316 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HIGH FLOW INSUFFLATION UNIT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 16, 2026Class IIOpen, 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 · names 2 of these models · Recall details · FDA record ↗

2. Jan 16, 2026Class IOpen, Classified

   Issue with software algorithm which may lead to overpressure events.

   Z-1354-2026 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

3. Sep 25, 2023Class IIOpen, 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 ↗

4. Sep 22, 2023Class IOpen, 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 HIGH FLOW INSUFFLATION UNIT problems

HIGH FLOW INSUFFLATION UNIT models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HIGH FLOW INSUFFLATION UNIT UHI-4

  INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
  3 recalls6 deaths2,484 reports
• HIGH FLOW INSUFFLATION UNIT UHI-3

  INSUFFLATOR, LAPAROSCOPIC
  1 recall162 reports
• HIGH FLOW INSUFFLATION UNIT UHI-3

  INSUFFLATOR, LAPAROSCOPIC
  1 recall48 reports
• HIGH FLOW INSUFFLATION UNIT UHI-4

  Insufflator, Automatic Carbon-Dioxide For Endoscope
  1 recall9 reports

Recent HIGH FLOW INSUFFLATION UNIT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211216 ↗
• 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 ↗
• InjuryJul 31, 2026Increase in Pressure

  It was reported that that during the appendectomy procedure using this insufflation unit, the patient had a cardiac arrest. As the anesthesiologist reported that the patient arrested due to excess carbon dioxide (CO2) pressure that the equipment delivered to the patient. A pressure value was set and the equipment delivered pressure higher than the set value. Additional information was requested but not available at this time. There were no further reports of patient harm.

  Patient problems: Cardiac Arrest

  MAUDE report 50101076 ↗
• 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, 2026Decrease in Pressure

  THE CUSTOMER REPORTED THE HIGH FLOW INSUFFLATION UNIT WAS UNABLE TO MAINTAIN PRESSURE DURING A THERAPEUTIC LAPAROSCOPIC PROCEDURE. THE EVENT RESULTED IN A DELAY TO THE PROCEDURE OF LESS THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436369 ↗
• 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 31, 2026Gas/Air Leak; Pressure Problem

  IT WAS OBSERVED THAT DURING THE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT FAILS SECONDARY PIPING LEAKAGE TEST, BUT A SUBSTITUTE TEST EMERGENCY PRESSURE (EP) VALVE FIXED THE ISSUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25341132 ↗
• 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 27, 2026Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED THE HIGH FLOW INSUFFLATOR FLOW RATE WAS NOT JUMPING BACK UP TO 20 MMHG TO INSUFFLATE. THE ISSUE WAS FOUND DURING A THERAPEUTIC LAPAROSCOPIC POLYPECTOMY PROCEDURE AND RESULTED IN A PROCEDURE PROLONGATION OF GREATER THAN OR EQUAL TO 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306450 ↗
• 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 ↗

Other Olympus Medical Systems Corp. products

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• EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
• EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
• EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
• HD CAMERA HEAD2 models · 5,217 reports