HIGH FLOW INSUFFLATION UNIT UHI-3 (UDI 04953170140280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 04953170140280), received between Aug 25, 2020 and Jul 31, 2026 — classified as 3 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (7 reports).

1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 16, 2026Open, Classified

   Issue with software algorithm which may lead to overpressure events.

   Z-1354-2026 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 15, 2026Increase in Pressure

  IT WAS REPORTED, THE INSUFFLATION UNIT EXHIBITED EXCESSIVE INSUFFLATION. UNSURE AS TO WHEN THE UNSPECIFIED EVENT OCCURRED. THERE WAS NO REPORT OF HARM, INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25193709 ↗
• MalfunctionDec 8, 2025Device Alarm System; Leak/Splash; Gas/Air Leak; Device Alarm System; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT THE HIGH FLOW INSUFFLATION UNIT WAS SQUEAKING AS IF THERE WERE AN INTERNAL AIR LEAK. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742630 ↗
• MalfunctionNov 25, 2025Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THE HIGH FLOW INSUFFLATION UNIT POWERED OFF AND THEN BACK ON BY ITSELF. THE ISSUE OCCURRED DURING A THERAPEUTIC GALL BLADDER REMOVAL PROCEDURE WHICH WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650517 ↗
• MalfunctionMar 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD LIQUID INSIDE THE INTERNAL HOSE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553002 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QIT WAS REPORTED A PNEUMOTHORAX OCCURRED WHILE USING THE HIGH FLOW INSUFFLATION UNIT DURING A THERAPEUTIC LAPAROSCOPIC HERNIA REPAIR. WHEN LOOKING AT THE DEVICE'S SETTING TO CHECK THE CAUSE, IT WAS SET TO 15 MMHG WHICH WAS HIGHER THAN NORMAL. THE DOCTOR COMPLETED THE PROCEDURE WITH THE SAME DEVICE AND THE INCIDENT DID NOT EXTEND THE PROCEDURE. THE FACILITY'S UNDERSTAND WAS THE SETTINGS SHOULD NOT CHANGE AUTOMATICALLY, SO THEY THOUGHT IT WAS DUE TO HUMAN ERROR. IT WAS REPORTED THAT DEVICE DID NOT CHANGE THE PRESSURE TO 15 MMHG ON ITS OWN. THE PATIENT'S CONDITION WAS STABLE AND THERE WERE NO PROBLEMS AT THE TIME OF THIS REPORT. THE PATIENT'S HOSPITALIZATION WAS NOT EXTENDED DUE TO THE EVENT. INFORMATION REGARDING TREATMENT FOR THE PNEUMOTHORAX WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 19547178 ↗
• MalfunctionMay 11, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT THE HIGH FLOW INSUFFLATION UNIT'S FRONT PANEL WAS BLINKING. THE ISSUE OCCURRED DURING INSPECTION FOR USE DURING A DIAGNOSTIC UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19294620 ↗
• MalfunctionFeb 29, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE INSUFFLATION UNIT EXHIBITED LEAKAGE FROM THE K CONNECTOR AND FOOT SWITCH CONNECTOR FOUND DAMAGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808933 ↗
• MalfunctionFeb 14, 2024Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT THE DEVICE MALFUNCTION DID NOT LEAD TO A DELAY IN THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707294 ↗
• MalfunctionDec 18, 2023Pressure Problem; Pressure Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE HIGH FLOW INSUFFLATION UNIT DID NOT MAINTAIN PRESSURE AND DID NOT KEEP THE CAVITY OPEN DURING A THERAPEUTIC CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) ENDOSCOPIC HARVESTING VEIN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIER: (B)(6). UHI-3 SN: (B)(6). RELATED PATIENT IDENTIFIER: (B)(6). UHI-3 SN: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18348435 ↗
• MalfunctionDec 7, 2023Gas/Air Leak; Gas/Air Leak

  THE CUSTOMER REPORTED THE HIGH FLOW INSUFFLATION UNIT HAD A LARGE INTERNAL LEAK. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281755 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INDICATION FOR THE PROCEDURE WAS SUSPECTED CA CORPUS. IT WAS NOT AN URGENT CASE BUT DELAYED A SURGICAL RESECTION OF TUMOR. IT DID NOT CAUSE A SERIOUS DETERIORATION IN THE PATIENT'S STATE OF HEALTH. THERE WERE NO RELEVANT PRE-EXISTING CONDITIONS FOR THE PATIENT. CURRENTLY, THE PATIENT HAS HAD A PRIVATE CARDIAC WORKUP INCLUDING CARDIAC MRI AND HOLTER DONE AND RESULTS ARE NORMAL. THE CANCELLED CASE HAS BEEN RESCHEDULED.

  Patient problems: Bradycardia

  MAUDE report 18261517 ↗
• MalfunctionNov 18, 2023Intermittent Loss of Power; Intermittent Loss of Power

  THE CUSTOMER REPORTED TO OLYMPUS THE INSUFFLATION UNIT DID NOT FULLY POWER UP AND BLINKED WHEN POWERED UP. THIS WAS DISCOVERED DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166889 ↗
• MalfunctionNov 14, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED TO OLYMPUS, THE HIGH FLOW INSUFFLATION UNIT THAT THE INSUFFLATOR WAS INTERMITTENT AND THERE WAS NO FLOW WHEN CONNECTED TO THE TROCAR. THE EVENT OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136651 ↗
• MalfunctionNov 8, 2023Gas Output Problem; Gas Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE CARBON DIOXIDE GAS VOLUME OF THE HIGH FLOW INSUFFLATION UNIT WAS LESS THAN THE DISPLAYED VOLUME. THE ISSUE WAS FOUND DURING A PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: ABNORMAL NOISE INSIDE THE DEVICE DUE TO LEAKAGE FROM THE FIRST REGULATOR UNIT AND LEAKAGE COMING FROM THE CONNECTOR UNIT. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18090507 ↗
• MalfunctionOct 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE LIGHT-EMITTING DIODE INDICATOR THAT SHOWS IF THE BOTTLES ARE FULL OR EMPTY DID NOT WORK ON THE HIGH FLOW INSUFFLATION UNIT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920789 ↗
• MalfunctionOct 2, 2023Gas/Air Leak; Gas/Air Leak

  THE OLYMPUS REPRESENTATIVE (ON BEHALF OF THE CUSTOMER) REPORTED TO OLYMPUS, THE HIGH FLOW INSUFFLATION UNIT HAD A GAS LEAK. THE ISSUE WAS FOUND DURING PREPARATION FOR USE, THE INTENDED THERAPEUTIC PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE, AND WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851939 ↗
• MalfunctionSep 7, 2023Pressure Problem; Pressure Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE HIGH FLOW INSUFFLATION UNIT EXPERIENCED THE AUTO SUCTION NOT WORKING. THERE WAS NO AIR INSUFFLATION. THE EVENT OCCURRED DURING PREPARATION FOR USE FOR THE INTENDED DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698707 ↗
• MalfunctionAug 1, 2023Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED TO OLYMPUS, THE HIGH FLOW INSUFFLATION UNIT HAD ITS FRONT PANEL BLINKING WITH THE ISSUE BEGINNING THE PREVIOUS WEEK. THE ISSUE WAS FOUND DURING THE THERAPEUTIC GALLBLADDER PROCEDURE. THERE WAS NO DELAY AND ANOTHER TOWER WAS PULLED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438741 ↗
• MalfunctionJul 13, 2023No Pressure; No Pressure

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING PREPARATION FOR A DIAGNOSTIC PROCEDURE, THE HIGH FLOW INSUFFLATION UNIT WOULD NOT INSUFFLATE. AT A CERTAIN POINT WHILE USING THE DEVICE, THE AIR PRESSURE SHUT DOWN. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321782 ↗
• MalfunctionJul 11, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE HIGH FLOW INSUFFLATION UNIT WAS RETURNED AS PART OF THE ASSET RETURN PROCESS. DURING ROUTINE INSPECTION OF THE DEVICE BY OLYMPUS, IT WAS FOUND THAT THERE WAS NO DISPLAY ON THE FRONT PANEL DUE TO A FAULTY PRINTED CIRCUIT BOARD. THERE WAS NO PROCEDURAL OR PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17303030 ↗
• MalfunctionApr 15, 2023Pressure Problem; Pressure Problem

  THE CUSTOMER REPORTED THE HIGH FLOW INSUFFLATION UNIT PRESSURE SHUT DOWN DURING INSUFFLATION. THE EVENT OCCURRED DURING PREPARATION FOR USE, PRIOR TO A DIAGNOSTIC PROCEDURE. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748516 ↗
• MalfunctionApr 14, 2023Electrical Power Problem; Electrical Power Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE HIGH FLOW INSUFFLATION UNIT, POWER OR FRONT PANEL ISSUE UNIT FELL OFF STAND, FRONT PANEL DAMAGED, CRUSHED ONE CORNER. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744419 ↗
• MalfunctionApr 13, 2023Gas/Air Leak; Gas/Air Leak

  THE CUSTOMER REPORTED THAT WHILE PERFORMING ROUTINE MAINTENANCE ON HIS OLYMPUS HIGH FLOW INSUFFLATION UNIT HAD A GAS LEAKAGE SOUND COMING FROM INSIDE THE UNIT. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731716 ↗
• MalfunctionApr 5, 2023Failure to Power Up; Failure to Power Up

  A USER FACILITY RETURNED THE OLYMPUS ASSET, HIGH FLOW INSUFFLATION UNIT, TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE UNIT WAS NOT TURNING ON. THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16680009 ↗