PNEUMOCLEAR FM300 (UDI 04056702001308)Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 04056702001308), received between Sep 10, 2018 and Jul 6, 2026 — classified as 38 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, 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 ↗
• 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 ↗
• InjuryNov 9, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "THE COMPLAINT WAS THAT THE INSUFFLATOR WAS NOT READING PRESSURE CORRECTLY DURING AND CAUSED THE PATIENT'S PENIS TO INCREASE IN SIZE (INSUFFLATE). THE ISSUE WAS NOT RECOGNIZED UNTIL AFTER THE PROCEDURE WAS COMPLETED. HOW WAS ISSUE NOTICED?: DURING PROCEDURE COMPLETED SUCCESSFULLY?: YES. PATIENT INVOLVEMENT?: YES - IMPACT. MEDICAL INTERVENTION?: NO. SURGICAL DELAY?: NO. ADVERSE CONSEQUENCES?: NO. ADVERSE CONSEQUENCE DETAILS: NO DELAYS, CAUSED THE PATIENT'S PENIS TO INCREASE IN SIZE (INSUFFLATE). UPDATE: THE PATIENT'S PENIS INCREASED IN SIZE UP TO 4X AND SPLIT OPEN. PRODUCT AVAILABLE FOR RETURN?: RETURN. ADDITIONAL INFORMATION FROM STRYKER EMPLOYEE ON 10/23/2023. ALSO HERE IS ADDITIONAL INFORMATION LOGGED FOR THIS COMPLAINT: "CALL WITH REP STATES THAT THE PENIS INCREASED IN SIZE 4 TIMES AND SPLIT OPEN REQUIRING STITCHES TO CLOSE IT. DOCTOR DOES NOT BELIEVE THE INSUFFLATOR IS AT FAULT BUT WANTED TO USE A DIFFERENT INSUFFLATOR AT THE TIME. WANTS THIS INSUFFLATOR SENT BACK FOR INVES-TIGATION. EVENT OCCURED 6 WEEKS AGO." DEVICE IDENTIFICATION => THE RETURNED DEVICE WAS CONFIRMED TO BE A PNEUMOCLEAR INSUFFLATOR S/N (B)(6). RMA 3025105" ADDITIO

  Patient problems: Tissue Breakdown

  MAUDE report 18100098 ↗
• InjuryNov 3, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING INSUFFLATION, THE PATIENT'S PENIS INCREASED IN SIZE AND SPLIT OPEN.

  Patient problems: Rupture

  MAUDE report 18069848 ↗
• InjurySep 14, 2023Pressure Problem; Pressure Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: " PNEUMOCLEAR GAS PRESSURE LOW MSG WITH NEW GAS TANKS. RE-PORTED BY BIOMED (B)(6), DURING A CASE, WHILE THE CASE WAS STILL GOING ON. HAVE THE SETUP WITH TWO TANKS. BOTH TANKS ARE NEW BEFORE THE CASE. CONTINUED TO PROVIDE GAS THROUGH THE SURGERY. NO DELAY TO THE SURGERY - WHEN REPORTED THE CASE WAS STILL GOING ON. DID SAY THE 2 YEAR MAINTENANCE STICKER SAYS SHOULD BE DUE JUNE 2023. CUSTOMER MAY HAVE RECEIVED THAT MESSAGE ALSO. ADDITIONAL INFORMATION FROM WOM EMPLOYEE (B)(4). ON 2023-07-13 "...DEVICE IDENTIFICATION => THE RETURNED DEVICE WAS CONFIRMED TO BE A PNEUMOCLEAR INSUFFLATOR SN: (B)(6) RMA: 3024258. INTERIM EVALUATION RESULTS AT WOM SIDE NO NEGATIVE TREND VISIBLE. REVIEW OF THE DHR REVEALED NO DISCREPANCIES. THE INFORMATION OBTAINED DOES NOT INDICATE THAT THE DEVICE HAS CAUSED OR IS LIKELY TO CAUSE DEATH, SERIOUS INJURY OR MALFUNCTION IN A MANNER THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF REPEATED. ADDITIONAL INFORMATION FROM STRYKER EMPLOYEE (B)(4). ON 2023-08-15 "HELLO ALL, I'M SORRY IT APPEARS THE ADDITIONAL INFORMATION WAS NOT SHARED WITH WOM. THE ORIGINAL NOTIFICATION FORM DOES NOT INCLUDE ANY A

  Patient problems: Laceration(s)

  MAUDE report 17742982 ↗
• InjuryAug 24, 2023Insufficient Device Problem Information; Complete Loss of Power; Insufficient Device Problem Information; Complete Loss of Power

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: ISSUE HAPPENED ABOUT A WEEK AGO. TOP RIGHT OF THE SCREEN OF THE PNEUMOCLEAR SHOWED A "LIGHTNING BOLT". THE NURSE TOUCHED THE ICON AND THE UNIT SHUT OFF. IT WOULD NOT RESTART FOR THREE MINUTES. UNIT WAS SWAPPED OUT. UNIT WAS TURNED ON BEFORE SWAPPING IT OUT WITH NO ERROR MESSAGE. FOUND OUT YESTERDAY THAT DURING THE CASE THE PATIENT CODED DURING PROCEDURE. THE PATIENT WAS RESUSCITATED. THE UNIT WAS SENT OUT TO STRYKER. ACCOUNT TYPICALLY USES ADVANCED FLOW PRESSURE 15 FLOW RATE OF 5 L/MIN. WILL CRANK IT UP AFTER ACCESS. Q1: WHAT WAS THE SET PRESSURE? A1: ADVANCED MODE, SET PRESSURE 15. Q2: WAS THERE ANY OVERPRESSURE? A2: NOT NOTED ON THE SCREEN, BUT DR. MENTIONED HE THOUGHT THE ABDOMEN INFLATED QUICKLY. Q3: WAS THERE A SWAP OF THE DEVICE OF THE SAME TYPE? A3: YES THE DEVICE WAS SWAPPED WITH ANOTHER PNEUMOCLEAR. Q4: WHERE THERE ANY ERROR MESSAGES DISPLAYED? A4: "LIGHT-NING BOLT ICON; TOP RIGHT CORNER. NO MESSAGE, BRIEFLY NOTICED IT. WHEN SHE TOUCHED THE SCREEN, THE ENTIRE SCREEN WENT BLACK." (THIS IS THE WORDING FROM THE NURSE THAT FILED THE REPORT). Q5: WAS THERE ANY RELATION IN TIME, WHEN THE SHUT OFF OF THE DEVICE OCCURRED AND WHEN THE P

  Patient problems: Cardiac Arrest

  MAUDE report 17610610 ↗
• MalfunctionAug 18, 2023Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT CODED DURING PROCEDURE. THE PATIENT WAS RESUSCITATED.

  Patient problems: Cardiac Arrest

  MAUDE report 17578975 ↗
• InjuryMay 16, 2023Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO BE VENTILATED DURING THE CASE.

  Patient problems: Airway Obstruction

  MAUDE report 16943265 ↗
• InjuryMay 3, 2023Off-Label Use; Device Handling Problem; Off-Label Use; Device Handling Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "PEDIATRIC CASE PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS) WAS OVER PRESSURED WITH PATIENT. PATIENT VITALS WENT DOWN WHEN INSUFFLATION STOPPED. THE PATIENT'S VITALS WENT BACK TO NORMAL. (...) WE WERE USING A 5MM SCOPE WITH A SIZE 5MM TROCAR (ONB5SHF). THE INSUFFLATOR BOX DIDN'T GIVE OFF ANY WARNING SIGNALS OR SOUNDS, WE WERE ONLY AWARE BECAUSE OF THE PATIENTS' STATUS CHANGING.". HOW WAS ISSUE NOTICED?: DURING. PROCEDURE COMPLETED SUCCESSFULLY?: NO. PATIENT INVOLVEMENT?: YES - IMPACT. MEDICAL INTERVENTION?: NO. SURGICAL DELAY?: YES - 20 MIN. ADVERSE CONSEQUENCES?: PATIENT AND USER. ADVERSE CONSEQUENCE DETAILS: 20 MINUTE DELAY TO SWAP OUT TOWERS WITH NEW PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR. PRODUCT AVAILABLE FOR RETURN?: RETURN.

  Patient problems: Insufficient Information

  MAUDE report 16864925 ↗
• InjuryApr 26, 2023Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED NEGATIVE IMPACT TO THEIR VITALS.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 16820287 ↗
• InjuryApr 11, 2023Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM SUBCUTANEOUS EMPHYSEMA RESULTING IN THE PATIENT NEEDING A CHEST TUBE AND ICU CARE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 16718655 ↗
• InjuryMay 20, 2022Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem

  IT WAS REPORTED THAT THE PATIENT CODED DURING PROCEDURE AND WAS AIRLIFTED TO ANOTHER HOSPITAL .

  Patient problems: Cardiac Arrest

  MAUDE report 14453107 ↗
• InjurySep 21, 2021Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Infusion or Flow Problem

  IT WAS REPORTED THE PROCEDURE WAS CONVERTED TO OPEN SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506303 ↗
• InjuryAug 17, 2021Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SUBCUTANEOUS EMPHYSEMA AND CREPITUS.

  Patient problems: Dyspnea; Infiltration into Tissue

  MAUDE report 12333907 ↗