Pneumosure 0620040600Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327063219), received between Feb 8, 2019 and Jun 5, 2025 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Image Display Error/Artifact; Decrease in Pressure; Increase in Pressure; Image Display Error/Artifact; Decrease in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PNEUMOSURE PRESSURE ROSE ABOVE THE SET PRESSURE BUT INSTEAD OF THE INSUFFLATOR GIVING AN ¿OVERPRESSURE¿ WARNING MESSAGE OR MAKING ANY AUDITORY BEEPING OR ANY SOUND, THE INSUFFLATION STOPPED. AT THAT POINT PRESSURE BEGAN DECREASING AND FLOW WAS AT 0. TO BEGIN INSUFFLATING AGAIN THE ¿START¿ BUTTON HAD TO BE PRESSED ON THE INSUFFLATOR ITSELF. THEREFORE, THERE WAS OVERPRESSURE AND LOSS OF INSUFFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152888 ↗
• MalfunctionApr 17, 2025Increase in Pressure; Pressure Problem; Increase in Pressure; Pressure Problem

  IT WAS REPORTED THAT DURING A CASE THE INSUFFLATOR WAS NOT GIVING AN ACCURATE PRESSURE OR FLOW READING THAT CAUSED OVER DISTENSION OF THE PATIENT. THEY HAD TO SHUT THE INSUFFLATOR OFF AND START AN OPEN CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860549 ↗
• MalfunctionMar 7, 2024No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THERE WAS LOSS OF INSUFFLATION DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862106 ↗
• InjuryApr 21, 2023No Flow; Pressure Problem; No Flow; Pressure Problem

  IT WAS REPORTED THAT THE CASE WAS DELAYED A FEW DAYS DUE TO LOSS OF INSUFFLATION DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Peritoneal Laceration(s)

  MAUDE report 16792208 ↗
• MalfunctionJun 30, 2022No Pressure; Output Problem; No Pressure

  IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14878685 ↗
• MalfunctionMay 27, 2022Pressure Problem; Therapeutic or Diagnostic Output Failure; Pressure Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522242 ↗
• MalfunctionMay 27, 2022Pressure Problem; Therapeutic or Diagnostic Output Failure; Pressure Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522241 ↗
• MalfunctionMay 27, 2022Pressure Problem; Therapeutic or Diagnostic Output Failure; Pressure Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522240 ↗
• MalfunctionMay 26, 2022Pressure Problem; Therapeutic or Diagnostic Output Failure; Pressure Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516438 ↗
• MalfunctionApr 28, 2022Increase in Pressure; Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT PATIENT HAD SUFFERED A COLLAPSED LUNG DUE TO OVERPRESSURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pneumothorax

  MAUDE report 14240411 ↗
• MalfunctionJan 18, 2022Pressure Problem; Increase in Pressure; Pressure Problem

  IT WAS REPORTED THAT THERE WAS OVERPRESSURE DURING PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282742 ↗
• InjuryOct 14, 2021Increase in Pressure; Increase in Pressure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXCESSIVE CO2 LEVELS.

  Patient problems: Chemical Exposure; Electrolyte Imbalance; Low Oxygen Saturation

  MAUDE report 12636594 ↗
• MalfunctionMay 26, 2021Inflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882364 ↗
• MalfunctionMay 25, 2021Inflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882319 ↗
• MalfunctionOct 13, 2020Calibration Problem; Calibration Problem; Pressure Problem

  IT WAS REPORTED THAT THERE WAS INLET GAS PRESSURE ISSUE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10673365 ↗
• MalfunctionFeb 8, 2019Device Alarm System; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE WAS OVER INFLATING WITH NO ALARMS. PLEASE NOTE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8321864 ↗