HIGH FLOW INSUFFLATION UNIT UHI-4 (REF N3829642)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170467219), received between Apr 21, 2025 and Aug 11, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (2 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. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, 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 ↗
• 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 ↗
• 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 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 ↗
• MalfunctionJan 23, 2026Excess Flow or Over-Infusion

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172984 ↗
• MalfunctionJun 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SUBJECT DEVICE'S GAS LINE EXPLODED/SPLIT OPEN WHEN CONNECTED TO E-TANK. THE ISSUE OCCURRED DURING THERAPEUTIC LAPAROSCOPIC SPAY PROCEDURE THAT WAS COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292940 ↗
• MalfunctionMay 27, 2025Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A CIRCUIT BOARD FAILURE, THE ISSUE OCCURRED RUING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090306 ↗
• MalfunctionApr 30, 2025Suction Problem; Suction Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DETERIORATION OF THE PINCH VALVE AND THE FADED TEXTS ON THE REAR PANEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936847 ↗
• MalfunctionApr 21, 2025Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873915 ↗