Pneumosure 0620040610Recalls & reported problems
Stryker Corporation · XL High Flow Insufflator · Class 2
All models of Pneumosure (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Pneumosure is an insufflator, a machine that pumps gas into the abdomen during keyhole surgery. Its 79 reports include 1 death and 19 injuries, and most describe malfunctions (59 reports): the device switching off during procedures, losing gas flow, or not showing the pressure reading. Some reports mention slow heart rate and cardiac arrest in patients. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 79
- Deaths reported
- 1
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 07613327063295), received between May 22, 2018 and Sep 15, 2026 — classified as 1 death, 19 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (22 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Pressure Problem22
- Decrease in Pressure17
- Increase in Pressure17
- Adverse Event Without Identified Device or Use Problem15
- Output Problem10
- Insufficient Device Problem Information8
- Therapeutic or Diagnostic Output Failure7
- Appropriate Device Problem Term/Code Not Available5
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Insufficient Information19
- No Known Impact Or Consequence To Patient18
- Bradycardia8
- Cardiac Arrest5
- Asystole3
- No Code Available3
- Swelling/ Edema2
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Device Displays Incorrect Message
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782083 ↗MalfunctionSep 14, 2026Device Displays Incorrect Message
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765827 ↗MalfunctionAug 14, 2026Decrease in Pressure; Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50257005 ↗MalfunctionMay 29, 2026Decrease in Pressure; Difficult or Delayed Activation
IT WAS REPORTED THAT THE DEVICE TURNED OFF 4 TIMES DURING A CASE, NO CASE DELAYS/PATIENT INVOLVEMENT. THEREFORE, THERE WAS LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25335793 ↗MalfunctionMar 25, 2026Decrease in Pressure; Increase in Pressure; Unable to Obtain Readings
IT WAS REPORTED THAT THE STRYKER PNEUMOSURE INSUFFLATION DEVICE APPEARS TO HAVE FAILED DURING SURGERY. UPON INSUFFLATION OF THE PATIENT'S ABDOMEN IN O.R. 9, THE DEVICE WAS SET TO 15 MM OF PRESSURE, AND HIGH FLOW. THE INSUFFLATION STARTED, AND THE PATIENTS BELLY INSUFFLATED, YET THE MACHINE DID NOT SHOW A LIVE RESPONSE OF THE ACTUAL PRESSURE. PERHAPS THE PRESSURE SENSOR HAS FAILED. THE DEVICE CONTINUED TO INFLATE THE ABDOMEN, UNTIL THE SURGEON NOTICED THAT THE DEVICE WAS NOT SHOWING ACTIVE PRESSURE. THE UNIT WAS STOPPED, AND IMMEDIATELY PULLED FROM SERVICE. THEREFORE, THERE WAS LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691775 ↗MalfunctionOct 23, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE STOPPED DURING PROCEDURE AND WOULD NOT COME BACK ON. THERE WAS A LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23374520 ↗MalfunctionSep 11, 2025Decrease in Pressure; Intermittent Loss of Power; Decrease in Pressure; Intermittent Loss of Power
IT WAS REPORTED THAT THE DEVICE POWERS OFF DURING PROCEDURE. NO ADDITIONAL INFORMATION WAS RECEIVED THEREFORE, THERE WAS A LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23033707 ↗MalfunctionSep 11, 2025Decrease in Pressure; Intermittent Loss of Power; Decrease in Pressure; Intermittent Loss of Power
IT WAS REPORTED THAT THE DEVICE POWERS OFF DURING PROCEDURE. NO ADDITIONAL INFORMATION WAS RECEIVED THEREFORE, THERE WAS A LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23033706 ↗MalfunctionJun 13, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE DID NOT RESPOND ADEQUATELY TO THE DESIRED CONFIGURATION, AND IT WAS OBSERVED THAT THE PATIENT WAS IN THE PROCESS OF DEFLATION. IT WAS NECESSARY TO ADJUST THE AMOUNT ADMINISTERED TO MAINTAIN STABILITY UNTIL THE EQUIPMENT WAS REPLACED. THEREFORE, THERE WAS LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22204448 ↗InjuryFeb 10, 2025Decrease in Pressure; Output Problem; Decrease in Pressure; Output Problem
IT REPORTED THE THERE WAS CONVERSION TO OPEN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21349661 ↗DeathDec 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THERE WAS PATIENT DEATH, NO OTHER INFORMATION WAS GIVEN. MULTIPLE ATTEMPTS FOR FURTHER INFORMATION WERE MADE, HOW NO RESPONSE WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 20972868 ↗InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE.
Patient problems: Asystole; Cardiac Arrest
MAUDE report 20763078 ↗InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE.
Patient problems: Asystole; Cardiac Arrest
MAUDE report 20762228 ↗InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE.
Patient problems: Asystole; Cardiac Arrest
MAUDE report 20762158 ↗InjuryNov 20, 2024Increase in Pressure; Output Problem; Increase in Pressure; Output Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA DUE TO OVERPRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Swelling/ Edema
MAUDE report 20741219 ↗InjuryNov 20, 2024Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA DUE TO OVERPRESSURE.
Patient problems: Swelling/ Edema
MAUDE report 20740857 ↗MalfunctionJul 24, 2024Increase in Pressure; Output Problem; Increase in Pressure; Output Problem
IT WAS REPORTED THAT THERE WAS OVERPRESSURE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19823492 ↗MalfunctionJul 24, 2024Increase in Pressure; Output Problem; Increase in Pressure; Output Problem
IT WAS REPORTED THAT THERE WAS OVERPRESSURE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19818170 ↗MalfunctionMar 18, 2024No Flow; Output Problem; No Flow; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18923327 ↗MalfunctionMar 13, 2024No Flow; Output Problem; No Flow; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18899258 ↗MalfunctionDec 14, 2023Smoking; Temperature Problem; Smoking; Temperature Problem
IT WAS REPORTED THAT THE DEVICE WAS EMITTING SMOKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326472 ↗MalfunctionOct 27, 2023Increase in Pressure; Difficult or Delayed Activation; Increase in Pressure; Difficult or Delayed Activation
IT WAS REPORTED THAT THERE WAS OVERPRESSURE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18025023 ↗MalfunctionAug 9, 2023Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT THERE WAS INLET GAS PRESSURE ISSUES DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17492999 ↗MalfunctionJul 12, 2023Gas Output Problem; Device Displays Incorrect Message; Gas Output Problem; Device Displays Incorrect Message
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
MAUDE report 17312857 ↗MalfunctionMay 17, 2023Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16946979 ↗
Other INSUFFLATOR, LAPAROSCOPIC devices
- HIGH FLOW INSUFFLATION UNIT UHI-3Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC1 recall162 reports
- HIGH FLOW INSUFFLATION UNIT UHI-3Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC1 recall48 reports
- AIRSEAL AS-iFS1Conmed Corporation · Insufflator, laparoscopic4 deaths93 reports
- Pneumosure 0620040690Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall22 reports
- Pneumosure 0620040660Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall18 reports
- CYLINDER HOSE (PIN) FOR UHI-3 MAJ-1080Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC58 reports
- Pneumosure 0620040680Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall0 reports
- STORZ 20400161SCanadian Hospital Specialties Limited · Insufflator, Laparoscopic1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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