PNEUMOCLEARRecalls & reported problems across all models
W.O.M. World of Medicine GmbH · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls
- 0
We found 2 models of PNEUMOCLEAR by W.O.M. World of Medicine GmbH in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Sep 10, 2018 and Jul 6, 2026 — classified as 45 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Increase in Pressure” (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. 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
Most reported PNEUMOCLEAR problems
Device problems
- Adverse Event Without Identified Device or Use Problem18
- Increase in Pressure9
- Insufficient Device Problem Information9
- Nonstandard Device7
- Pressure Problem6
- Infusion or Flow Problem4
- Complete Loss of Power2
- Decrease in Pressure1
Patient problems
- Cardiac Arrest10
- No Clinical Signs, Symptoms or Conditions7
- Infiltration into Tissue6
- Insufficient Information5
- Bradycardia4
- Dyspnea4
- Unspecified Respiratory Problem4
- No Code Available3
PNEUMOCLEAR models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PNEUMOCLEAR FM300Insufflator, Endoscopic Vessel Harvesting40 reports
- PNEUMOCLEAR FM300Insufflator, Endoscopic Vessel Harvesting8 reports
Recent PNEUMOCLEAR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 6, 2026Decrease in Pressure
It was during vein harvesting the unit collapsed the vein despite not having suction tubing. Staff also stated it's not keeping the vein insufflated properly. Since we had an issue with the insufflator tubing with some backflow. The PA decided to convert to open the arm to harvest the radial artery instead of doing it endoscopically.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25725562 ↗InjuryMay 26, 2026Increase in Pressure
IT WAS REPORTED THAT THE PATIENT BECAME BRADYCARDIC. SET PRESSURE WAS LOWER THAN USUAL SETTING ACCORDING TO THE SURGEON (PRESSURE AT 12MMHG, FLOW AT 20L/MIN).
Patient problems: Bradycardia
MAUDE report 25288813 ↗InjuryJan 5, 2026Insufficient Device Problem Information
WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: ADDITIONAL INFORMATION WAS RECEIVED FROM (B)(6) ON (B)(6) 2026. "THE REPORTED EVENT OCCURRED DURING A LAPAROSCOPIC SALPINGECTOMY PERFORMED USING THE INSUFFLATOR IN STANDARD MODE WITH A SET PRESSURE OF 15 MMHG AND REGULAR INSUFFLATOR TUBING. APPROXIMATELY 30-45 MINUTES INTO THE PROCEDURE (TOTAL CASE TIME 1 HOUR 15 MINUTES), WHILE THE SURGEON WAS ATTEMPTING TO ACCESS AND DISSECT THE FALLOPIAN TUBE, ANESTHESIA ALERTED THE SURGICAL TEAM TO A CHANGE IN THE PATIENT'S VITALS AND CODED. NO DEVICE WARNINGS OR ALARMS WERE OBSERVED, AND THE DURATION OF ANY PRESSURE SPIKE COULD NOT BE DETERMINED, AS THE USER WAS NOT IMMEDIATELY AWARE OF AN ISSUE. THE SAME INSUFFLATOR WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT (FEMALE, 35 YEARS OLD, BMI 37) WAS STABLE PRIOR TO THE PROCEDURE AND STABLE POST PROCEDURE FOLLOWING RESUSCITATION. NO ADDITIONAL INJURIES, MEDICAL INTERVENTIONS, OR PROLONGED HOSPITALIZATION WERE REPORTED"
Patient problems: Cardiac Arrest
MAUDE report 23956862 ↗InjuryDec 19, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT PRESSURE SPIKED TOWARDS THE END OF THE CASE. IT WAS FURTHER REPORTED THAT PATIENT CODED.
Patient problems: Cardiac Arrest; Insufficient Information
MAUDE report 23851338 ↗InjuryOct 15, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED BY THE CUSTOMER THAT WHEN THEY PLUGGED IN THE INSUFFLATION TUBING TO THE MACHINE AND SELECTED THE PRESSURE AND FLOW SETTINGS BUT HAD NOT YET PRESSED START, A MESSAGE CAME UP. UPON HITTING START, THE SETTINGS FOR THE PRESSURE WERE SET AT 12 AND THE NUMBER CLIMBED TO 30 (EVEN WITH THE 12 SETTING). IT WAS FURTHER REPORTED THAT THE PATIENT'S STOMACH WAS VERY HARD AND THE TROCAR HAD TO BE RELEASED TO LET THE CO2 OUT. AFTER TURNING THE MACHINE OFF AND THEN BACK ON, IT WORKED FINE. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION REGARDING COMPLETION OF SURGERY, SURGICAL DELAY, MEDICAL INTERVENTION, AND ADVERSE EVENT DETAILS, HOWEVER NO NEW INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 23304588 ↗InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "PATIENT HEART STOPPED WHILE DOING SURGERY DEVICE WAS BEING USED. THE PATIENT MADE IT THROUGH SURGERY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY."
Patient problems: Cardiac Arrest
MAUDE report 22553697 ↗InjuryJul 2, 2025Decrease in Suction; Decrease in Suction
IT WAS REPORTED THAT THE SURGEON WAS SUPPOSED TO PERFORM A BILATERAL OOPHORECTOMY ON THE FRIDAY. INSTEAD, SHE ONLY REMOVED ONE. THE PATIENT HAD TO GO BACK INTO SURGERY SATURDAY TO HAVE THE OTHER OVARY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22383925 ↗InjuryMay 9, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT THE PATIENT DEVELOPED SUBCU CREPITUS AND HAD TO REMAIN INTUBATED AND SENT TO THE ICU. IN ICU FOR LESS THAN 24 HOURS AND WAS DISCHARGED.
Patient problems: Infiltration into Tissue
MAUDE report 21998016 ↗InjuryJan 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT EXPERIENCED BRADYCARDIA REQUIRING CPR AND CONVERSION PROCEDURE WAS CONVERTED TO OPEN SURGERY.
Patient problems: Cardiac Arrest
MAUDE report 21069322 ↗MalfunctionNov 13, 2024Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20679036 ↗InjuryNov 13, 2024Pressure Problem; Pressure Problem
IT WAS REPORTED THAT MEDICAL INTERVENTION WAS PERFORMED TO PREVENT THE PATIENT FROM CODING.
Patient problems: Respiratory Insufficiency
MAUDE report 20678806 ↗InjuryApr 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE PNEUMOCLEAR CO2 CONDITIONING INSUFFLATOR (#(B)(6)) MALFUNCTIONED WHILE THE PA-C (CERTIFIED PHYSICIAN'S ASSISTANT) WAS USING IT FOR ENDOSCOPIC VEIN HARVESTING. INITIALLY, THE EQUIP-MENT SHOWED THAT INSUFFLATION WAS ACTIVE,' BUT THE PA-C WAS STRUGGLING WITH THE VIEW OF THE VEIN ON THE MONITOR. STRYKER WAS PAGED UPON THIS DISCOVERY AND THEN IT BEGAN WORKING ON ITS OWN BEFORE THEY MADE IT TO THE ROOM. APPROXIMATELY AN HOUR LATER, THE EQUIPMENT WAS ALARMING THAT THERE WAS AN OCCLUSION.' WRITER PAGED STRYKER AGAIN AND OBTAINED NEW INSUFFLATION TUBING AND VASOVIEW ACCESSORY KIT, IN THE EVENT THAT IT WAS A PART OF THE ISSUE. PA-C WAS UNABLE TO TROUBLESHOOT WITH THE NEW SUPPLIES AND STRYKER WAS UNABLE TO TROUBLESHOOT THE EQUIPMENT. A NEW PNEUMOCLEAR CO2 CONDITIONING INSUFFLATOR WAS BROUGHT TO THE ROOM AND SET UP BY STRYKER. THE NEW EQUIPMENT WORKED; HOWEVER, AT THIS POINT THE PA-C HAD TO GO OPEN' IN ORDER TO RETRIEVE THE VEIN FROM THE PATIENT'S LEG. WHICH THUS CAUSED FOUR ADDITION-AL INCISIONS IN THE PATIENT'S LEG AND A DELAY IN THE SURGERY. HOW WAS ISSUE NOTICED?: DURING PROCEDURE. PROCEDURE COMPLETED SUCCESSFULLY?: YES. PATIENT INVOLVEMENT?: YES - IMPACT. MEDICAL INTERVENTION?: YES. S
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 19039870 ↗InjuryApr 2, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO OPEN SURGERY AND ADDITIONAL INCISIONS TO THE PATIENT'S LEG.
Patient problems: Unintended Loss of Vascular Access
MAUDE report 19028975 ↗InjuryDec 21, 2023Increase in Pressure; Increase in Pressure
IT WAS REPORTED THE PATIENT EXPERIENCED HIGH LEVELS OF CO2 AND CREPITUS.
Patient problems: Infiltration into Tissue
MAUDE report 18374633 ↗InjuryDec 21, 2023Increase in Pressure; Increase in Pressure
IT WAS REPORTED THE PATIENT EXPERIENCED HIGH LEVELS OF CO2 AND CREPITUS.
Patient problems: Infiltration into Tissue
MAUDE report 18374501 ↗
Other W.O.M. World of Medicine GmbH products
All W.O.M. World of Medicine GmbH devices →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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