Pneumosure 0620040660Recalls & reported problems
Stryker Corporation · [High Flow Insufflator, Do not use if package is damaged, Keep dry, Keep away from sunlight, Protect from heat and radioactive sources.] · Class 2
All models of Pneumosure (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327055634), received between Jun 19, 2018 and Oct 15, 2025 — classified as 1 injury, 17 malfunctions.
The most frequently reported specific device problem is “Break” (5 reports).
1 FDA recall record name this device's 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, 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
Recalls naming this device
- Mar 7, 2019Class IITerminated
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 problems
Device problems
- Break5
- Disconnection3
- Output Problem3
- Pressure Problem3
- Connection Problem2
- Detachment of Device or Device Component2
- Nonstandard Device2
- Contamination /Decontamination Problem1
Patient problems
- No Known Impact Or Consequence To Patient9
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information5
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionMar 13, 2024Packaging Problem; Packaging Problem
IT WAS REPORTED THAT FOREIGN MATERIAL FOUND INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18899349 ↗MalfunctionSep 24, 2022Connection Problem; Connection Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TUBING CONNECTION DETACHED WHICH CAN POTENTIALLY LEAD TO LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15478656 ↗MalfunctionSep 24, 2022Connection Problem; Connection Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TUBING CONNECTION DETACHED WHICH CAN POTENTIALLY LEAD TO LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15477959 ↗MalfunctionSep 12, 2022Pressure Problem; Pressure Problem; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15403579 ↗MalfunctionJan 5, 2022Nonstandard Device; Output Problem; Nonstandard Device
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13170825 ↗MalfunctionJan 5, 2022Nonstandard Device; Output Problem; Nonstandard Device
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13170782 ↗MalfunctionMar 25, 2020Break
IT WAS REPORTED THAT THE TUBING HAS BROKEN CONNECTION POTENTIALLY LEADING TO A LOSS OF INSUFFLATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9880466 ↗MalfunctionMar 25, 2020Break
IT WAS REPORTED THAT THE TUBING HAS BROKEN CONNECTION POTENTIALLY LEADING TO A LOSS OF INSUFFLATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9880463 ↗MalfunctionMar 25, 2020Break
IT WAS REPORTED THAT THE TUBING HAS BROKEN CONNECTION POTENTIALLY LEADING TO A LOSS OF INSUFFLATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9880462 ↗MalfunctionMar 25, 2020Break
IT WAS REPORTED THAT THE TUBING HAS BROKEN CONNECTION POTENTIALLY LEADING TO A LOSS OF INSUFFLATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9880461 ↗MalfunctionJan 16, 2019Disconnection
IT WAS REPORTED THAT THE TUBING WAS DISCONNECTED, POTENTIALLY LEADING TO A LOSS OF INSUFFLATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8255444 ↗MalfunctionJan 16, 2019Disconnection
IT WAS REPORTED THAT THE TUBING WAS DISCONNECTED, POTENTIALLY LEADING TO A LOSS OF INSUFFLATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8255443 ↗MalfunctionJan 16, 2019Disconnection
IT WAS REPORTED THAT THE TUBING WAS DISCONNECTED, POTENTIALLY LEADING TO A LOSS OF INSUFFLATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8255442 ↗MalfunctionSep 10, 2018Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE OF THE STERILE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7862057 ↗MalfunctionJun 19, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE OF THE STERILE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7617350 ↗
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 0620040610Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 death79 reports
- Pneumosure 0620040690Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall22 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page