PneumosureRecalls & reported problems across all models
Stryker Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 135
- Deaths reported
- 1
- Injuries reported
- 22
- Recalls
- 3
We found 5 models of Pneumosure by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 135 adverse event reports in the FDA's MAUDE database, received between May 22, 2018 and Sep 15, 2026 — classified as 1 death, 22 injuries, 112 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (34 reports).
3 FDA recall records name at least one of these models by its device identifier.
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
Reports received per month, all models
Pneumosure 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.
- Mar 7, 2019Terminated
The heated tube sets were consistently leaking and detaching from the cassette.
Z-1728-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 7, 2019Terminated
The heated tube sets were consistently leaking and detaching from the cassette.
Z-1727-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 7, 2019Terminated
The heated tube sets were consistently leaking and detaching from the cassette.
Z-1726-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Pneumosure problems
Device problems
- Pressure Problem34
- Decrease in Pressure23
- Increase in Pressure22
- Output Problem19
- Adverse Event Without Identified Device or Use Problem16
- Therapeutic or Diagnostic Output Failure15
- Disconnection11
- Insufficient Device Problem Information8
Patient problems
- No Clinical Signs, Symptoms or Conditions67
- No Known Impact Or Consequence To Patient44
- Insufficient Information32
- Bradycardia9
- Cardiac Arrest5
- Asystole3
- No Code Available3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Pneumosure models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pneumosure 0620040610INSUFFLATOR, LAPAROSCOPIC1 death79 reports
- Pneumosure 0620040690INSUFFLATOR, LAPAROSCOPIC1 recall22 reports
- Pneumosure 0620040660INSUFFLATOR, LAPAROSCOPIC1 recall18 reports
- Pneumosure 0620040680INSUFFLATOR, LAPAROSCOPIC1 recall0 reports
- Pneumosure 0620040600INSUFFLATOR, LAPAROSCOPIC16 reports
Recent Pneumosure adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionOct 15, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE TUBING BROKE OFF ON THE TROCAR IN THE MIDDLE OF THE CASE WITH LOSS OF INSUFFLATION.
Patient problems: Insufficient Information
MAUDE report 23306000 ↗MalfunctionSep 16, 2025Break; Pressure Problem
TUBING BROKE OFF ON THE TROCAR IN THE MIDDLE OF THE CASE WITH LOSS OF INSUFFLATION.
Patient problems: Insufficient Information
MAUDE report 23061946 ↗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 ↗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 ↗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 ↗InjuryFeb 10, 2025Output Problem; Pressure Problem; Output Problem; Pressure Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO OPEN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21349644 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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