Pneumosure 0620040690Recalls & 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
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327055658), received between Aug 30, 2018 and Nov 27, 2024 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Disconnection” (8 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-1728-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Disconnection8
- Decrease in Pressure4
- Output Problem4
- Therapeutic or Diagnostic Output Failure3
- Appropriate Device Problem Term/Code Not Available2
- Leak/Splash2
- Connection Problem1
- Contamination /Decontamination Problem1
Patient problems
- No Known Impact Or Consequence To Patient15
- No Clinical Signs, Symptoms or Conditions6
- Bradycardia1
- Insufficient Information1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2024Decrease in Pressure; Output Problem; Decrease in Pressure; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20800965 ↗MalfunctionNov 27, 2024Decrease in Pressure; Output Problem; Decrease in Pressure; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20800808 ↗MalfunctionNov 27, 2024Decrease in Pressure; Output Problem; Decrease in Pressure; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20800781 ↗MalfunctionNov 27, 2024Decrease in Pressure; Output Problem; Decrease in Pressure; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20800773 ↗MalfunctionJan 20, 2022Connection Problem
ADULT FEMALE WITH HISTORY OF OBESITY AND PERSISTENT ATRIAL FIBRILLATION. PROCEDURE: HYBRID CONVERGENT MAZE PROCEDURE WITH POSTERIOR LEFT ATRIAL WALL ABLATION, LEFT ATRIAL APPENDAGE EXCLUSION WITH ATRICLIP. ISSUE: STRYKER CO2 HIGH FLOW TUBING WOULD NOT CONNECT TO THE STRYKER TOWER. NEW TUBING OBTAINED AND WORKED APPROPRIATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13306598 ↗MalfunctionNov 23, 2020Infusion or Flow Problem; Therapeutic or Diagnostic Output Failure; Infusion or Flow Problem
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING SURGERY DUE TO TUBING DISCONNECTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10886494 ↗MalfunctionAug 26, 2019Detachment of Device or Device Component
IT WAS REPORTED THAT THE TUBING BECAME DETACHED, WHICH COULD POTENTIALLY LEAD TO A LOSS OF INSUFFLATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8932398 ↗MalfunctionMay 8, 2019Disconnection; Leak/Splash
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DUE TO INSUFFLATION TUBING LEAKING AND DISCONNECTING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8592661 ↗MalfunctionMay 8, 2019Disconnection; Leak/Splash
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DUE TO INSUFFLATION TUBING LEAKING AND DISCONNECTING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8592645 ↗MalfunctionApr 30, 2019Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8563343 ↗MalfunctionMar 27, 2019Disconnection
IT WAS REPORTED THAT DURING SURGERY THERE WAS A POTENTIAL LOSS OF INSUFFLATION DUE TO INSUFFLATION TUBING DISCONNECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8456984 ↗MalfunctionMar 25, 2019Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT POTENTIAL LOSS OF INSUFFLATION OCCURED DURING SURGERY, DUE TO INSUFFLATION TUBING DISCONNECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8450108 ↗MalfunctionJan 31, 2019Disconnection
IT WAS REPORTED THAT THE INSUFFLATION TUBING DISCONNECTED DURING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8294484 ↗MalfunctionJan 31, 2019Disconnection
IT WAS REPORTED THAT THE INSUFFLATION TUBING DISCONNECTED DURING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8294481 ↗MalfunctionJan 30, 2019Disconnection
IT WAS REPORTED THAT THE INSUFFLATION TUBING DISCONNECTED DURING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8289674 ↗MalfunctionJan 30, 2019Disconnection
IT WAS REPORTED THAT THE INSUFFLATION TUBING DISCONNECTED DURING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8289673 ↗MalfunctionJan 30, 2019Disconnection
IT WAS REPORTED THAT THE INSUFFLATION TUBING DISCONNECTED DURING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8289668 ↗MalfunctionDec 28, 2018Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THERE WAS LOSS OF INSUFFLATION DURING SURGERY DUE TO INSUFFLATION TUBING DISCONNECTING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8203140 ↗MalfunctionDec 26, 2018Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THERE WAS CONTENTIONAL LOSS OF INSUFFLATION DUE TO TUBING DISCONNECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8197424 ↗MalfunctionDec 21, 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 8190544 ↗MalfunctionDec 5, 2018Gas/Air Leak; Noise, Audible
WHEN THE INSUFFLATION TUBING WAS INSERTED INTO THE STRYKER INSUFFLATION GENERATOR AN AUDIBLE AIR LEAKING WAS NOTED. THE CLEAR GAS TUBING WAS SLIGHTLY AJAR FROM THE GREY HOUSING; THIS RN WAS IN A CASE EARLIER WHERE THE EXACT NOISE/CIRCUMSTANCE OCCURRED. THE REMEDY FOR BOTH RNS WAS TO FIRMLY INSERT THE CLEAR TUBING FURTHER WITHIN THE GREY HOUSING AND THAT ELIMINATED THE NOISE. THE DOCTOR FELT THE INSUFFLATION WAS CONTINUING EVEN THOUGH THE GENERATOR AND ITS READINGS WERE ACCURATE AND THE MACHINE WAS GIVING TOO MUCH (CAUSING IT TO ERROR/ALARM). THE PATIENT BECAME BRADYCARDIC WITH A HEART RATE OF 22, GAS STOPPED, THE MDA WAS CALLED AND PHARMACOLOGICAL INTERVENTION WAS GIVEN WITH GOOD RESULT. ANOTHER INSUFFLATION GENERATOR WAS OBTAINED AND STAFF RESUMED THE CASE WITH THE NON-HEATED VERSION OF THE PNEUMOSURE. THE DOCTOR REUSED THE PRIOR USED HEATED TUBING WITH THE NEW GENERATOR, WITH A GOOD RESULT. NO LASTING HARM CAME TO THE PATIENT AND THE PROCEDURE WAS COMPLETED AS PLANNED. THE MACHINE WAS INSPECTED BY BIOMED WITH NO ISSUES FOUND AND THE TUBING WAS SENT TO CLINICAL ENGINEERING. THE TUBING WILL BE RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS. MANUFACTURER RESPONSE FOR INSUFFLATOR,
Patient problems: Bradycardia
MAUDE report 8132451 ↗MalfunctionAug 30, 2018Material Separation
PATIENT SCHEDULED FOR LAPAROSCOPIC CHOLECYSTECTOMY. WHEN IT WAS TIME FOR THE ABDOMEN TO BE INSUFFLATED WITH CARBON DIOXIDE, THE TEAM NOTED THAT THE ABDOMEN WAS NOT INSUFFLATED. WHEN THEY CHECKED, THE TUBING COVERING THE WIRES WAS NOT IN ITS PLACE. THEY APPEAR TO BE SEPARATED FROM THE GREY COLORED PLASTIC DISC. THE DEVICE WAS CHANGED AND ADEQUATE PNEUMOPERITONEUM WAS OBTAINED. LAP CHOLECYSTECTOMY PROCEEDED WITHOUT ANY MORE UNTOWARD EVENT. PATIENT TOLERATED PROCEDURE WELL WITH NO COMPLICATIONS. MANUFACTURER RESPONSE FOR INSUFFLATOR, LAPAROSCOPIC, PNEUMOSURE (PER SITE REPORTER). SURGERY INVENTORY COORDINATOR TO CALL COMPANY AND REPORT DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7831992 ↗
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 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 · 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