THERMOFLATOR 26432020-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04048551069264), received between Apr 7, 2017 and Jul 14, 2026 — classified as 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (2 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25817555 ↗
• MalfunctionJul 14, 2026Pressure Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25817554 ↗
• MalfunctionMay 22, 2026Pressure Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE INSUFFLATOR EXHIBITED ABNORMALLY HIGH OR LOW INFLATION PRESSURE AND FAILED TO AUTOMATICALLY INFLATE OR DEFLATE GAS ACCORDING TO THE SET PRESSURE. DUE TO INACCURATE INFLATION PRESSURE, A BACKUP DEVICE WAS USED AS A REPLACEMENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260834 ↗
• MalfunctionApr 9, 2026No Flow

  IT WAS REPORTED THAT ON (B)(6) 2025, IN THE OPERATING ROOM, THE DOCTOR USED THE INSUFFLATORTO EXPAND THE SURGICAL FIELD AND FOUND THAT THE INSUFFLATOR FAILED TO SUPPLY GAS, AFFECTING THEOPERATION. THE TECHNICAL STAFF WAS IMMEDIATELY CONTACTED FOR INSPECTION, AND THE EQUIPMENT WAS REPLACED. AFTER REPLACEMENT, THE OPERATION PROCEEDED NORMALLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835205 ↗
• MalfunctionFeb 13, 2026Improper Flow or Infusion; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE THORACOSCOPIC. A STORZ INSUFFLATOR WAS USED AT THE START OF THE SURGERY, AT WHICH POINT IT WAS FOUND THAT THE PNEUMOPERITONEUM COULD NOT BE MAINTAINED IN THE PATIENT, RESULTING IN A POOR SURGICAL FIELD OF VIEW. AFTER RULING OUT INSUFFICIENT CO2 SUPPLY FROM THE CENTRAL GAS SUPPLY SYSTEM, THE INSUFFLATOR WAS DETERMINED TO MALFUNCTION. THE INSUFFLATOR WAS REPLACED, AFTER WHICH IT FUNCTIONED NORMALLY; THE ENTIRE PROCESS TOOK APPROXIMATELY 20 MINUTES, AND THE SURGERY WAS SUCCESSFULLY COMPLETED IN THE END. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338597 ↗
• InjuryApr 20, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WERE INSUFFLATION PROBLEMS DURING SURGERY AND PRESSURE CHECK WAS NEEDED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT SUFFERED A PULMONARY EMPHYSEMA AND NEEDED ADDITIONAL HOSPITALIZATION AFTER SURGERY.

  Patient problems: Pulmonary Emphysema

  MAUDE report 16776918 ↗
• MalfunctionApr 20, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WERE INSUFFLATION PROBLEMS DURING SURGERY AND PRESSURE CHECK WAS NEEDED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT SUFFERED A PULMONARY EMPHYSEMA AND NEEDED ADDITIONAL HOSPITALIZATION AFTER SURGERY.

  Patient problems: Pulmonary Emphysema

  MAUDE report 16776917 ↗
• InjuryJan 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6) : DURING INSUFFLATION, THE PATIENT HAD A CARDIAC ARREST. THE CUSTOMER REPORTED THAT THE PATIENT HAS RECOVERED. (MFR'S. INTERNAL COMPLAINT # (B)(4)).

  Patient problems: Cardiac Arrest

  MAUDE report 13289321 ↗
• InjuryNov 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE INITIAL COMPLAINT REPORT NOTED THE FOLLOWING: OUR THERMOFLATOR UNIT WAS USED FOR VEIN HARVESTING PROCEDURES ON (B)(6), (B)(6) AND (B)(6) OF 2021 (AND POTENTIALLY TWO MORE). THE UNIT IS IN OR15. SURGEON IN ALL 3 CASES WAS DR. (B)(6). CUSTOMER DID NOT PROVIDE SPECIFIC INFORMATION ON THE INCIDENT. HOWEVER, PER THE CUSTOMER, THE INSUFFLATOR IS WORKING ACCORDING TO THE EQUIPMENT'S SPECIFICATIONS. THE ISSUE THAT THEY HAVE IDENTIFIED IS A POTENTIAL USER ERROR WITH THE INSUFFLATOR. THE USER HAD THE PRESSURE AND THE FLOW SETTINGS MUCH HIGHER THAN HE SHOULD HAVE DURING THE ENDOSCOPIC VEIN HARVESTING. PER OUR COMPLAINT INVESTIGATION, THE CUSTOMER STATED: AFTER ENDOSCOPIC VEIN HARVESTING STARTED, THE PATIENT'S END TIDAL CO2 STARTED TO RISE. ANESTHESIA MACHINE SHOWED INCREASE IN ETCO2. PATIENT'S BLOOD GAS SHOWED AN INCREASE IN PCO2. EFFORTS WERE MADE TO CORRECT THE CO2, BUT IT DID NOT DECREASE UNTIL ABOUT 1.5 HOUR WHEN ENDOSCOPIC VEIN HARVESTING WAS FINISHING. ANESTHESIA MACHINE SETTINGS WERE CHANGED IN ORDER TO LOWER ETCO2 (INCREASE RESPIRATORY RATE AND CHANGED OUT ALL HOSES AND FILTERS ON MACHINE). INTERVENTIONS DIDN'T HELP INITIALLY. NO PATIENT IMPACT OR INJURY IDENTIFIED. CUSTOMER ALSO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12872802 ↗
• InjuryNov 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE INITIAL COMPLAINT REPORT NOTED THE FOLLOWING: OUR THERMOFLATOR UNIT WAS USED FOR VEIN HARVESTING PROCEDURES ON (B)(6) OF 2021 (AND POTENTIALLY TWO MORE). THE UNIT IS IN OR 15. SURGEON IN ALL 3 CASES WAS DR. (B)(6). CUSTOMER DID NOT PROVIDE SPECIFIC INFORMATION ON THE INCIDENT. HOWEVER, PER THE CUSTOMER, THE INSUFFLATOR IS WORKING ACCORDING TO THE EQUIPMENT'S SPECIFICATIONS. THE ISSUE THAT THEY HAVE IDENTIFIED IS A POTENTIAL USER ERROR WITH THE INSUFFLATOR. THE USER HAD THE PRESSURE AND THE FLOW SETTINGS MUCH HIGHER THAN HE SHOULD HAVE DURING THE ENDOSCOPIC VEIN HARVESTING. PER OUR COMPLAINT INVESTIGATION, THE CUSTOMER STATED: AFTER ENDOSCOPIC VEIN HARVESTING STARTED, THE PATIENT'S END TIDAL CO2 STARTED TO RISE. ANESTHESIA MACHINE SHOWED INCREASE IN ETCO2. PATIENT'S BLOOD GAS SHOWED AN INCREASE IN PCO2. EFFORTS WERE MADE TO CORRECT THE CO2, BUT IT DID NOT DECREASE UNTIL ABOUT 1.5 HOUR WHEN ENDOSCOPIC VEIN HARVESTING WAS FINISHING. ANESTHESIA MACHINE SETTINGS WERE CHANGED IN ORDER TO LOWER ETCO2 (INCREASE RESPIRATORY RATE AND CHANGED OUT ALL HOSES AND FILTERS ON MACHINE). INTERVENTIONS DIDN'T HELP INITIALLY. NO PATIENT IMPACT OR INJURY IDENTIFIED. CUSTOMER ALSO STATED THAT THEY A

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12872798 ↗
• InjuryNov 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE INITIAL COMPLAINT REPORT NOTED THE FOLLOWING: OUR THERMOFLATOR UNIT WAS USED FOR VEIN HARVESTING PROCEDURES ON (B)(6), (B)(6) AND (B)(6) OF 2021 (AND POTENTIALLY TWO MORE). THE UNIT IS IN OR15. SURGEON IN ALL 3 CASES WAS DR. (B)(6). CUSTOMER DID NOT PROVIDE SPECIFIC INFORMATION ON THE INCIDENT. HOWEVER, PER THE CUSTOMER, THE INSUFFLATOR IS WORKING ACCORDING TO THE EQUIPMENT'S SPECIFICATIONS. THE ISSUE THAT THEY HAVE IDENTIFIED IS A POTENTIAL USER ERROR WITH THE INSUFFLATOR. THE USER HAD THE PRESSURE AND THE FLOW SETTINGS MUCH HIGHER THAN HE SHOULD HAVE DURING THE ENDOSCOPIC VEIN HARVESTING. PER OUR COMPLAINT INVESTIGATION, THE CUSTOMER STATED: AFTER ENDOSCOPIC VEIN HARVESTING STARTED, THE PATIENT'S END TIDAL CO2 STARTED TO RISE. ANESTHESIA MACHINE SHOWED INCREASE IN ETCO2. PATIENT'S BLOOD GAS SHOWED AN INCREASE IN PCO2. EFFORTS WERE MADE TO CORRECT THE CO2, BUT IT DID NOT DECREASE UNTIL ABOUT 1.5 HOUR WHEN ENDOSCOPIC VEIN HARVESTING WAS FINISHING. ANESTHESIA MACHINE SETTINGS WERE CHANGED IN ORDER TO LOWER ETCO2 (INCREASE RESPIRATORY RATE AND CHANGED OUT ALL HOSES AND FILTERS ON MACHINE). INTERVENTIONS DIDN'T HELP INITIALLY. NO PATIENT IMPACT OR INJURY IDENTIFIED. CUSTOMER ALSO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12870742 ↗
• InjuryNov 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE INITIAL COMPLAINT REPORT NOTED THE FOLLOWING: OUR THERMOFLATOR UNIT WAS USED FOR VEIN HARVESTING PROCEDURES ON (B)(6) OF 2021 (AND POTENTIALLY TWO MORE). THE UNIT IS IN OR15. SURGEON IN ALL 3 CASES WAS DR. (B)(6). CUSTOMER DID NOT PROVIDE SPECIFIC INFORMATION ON THE INCIDENT. HOWEVER, PER THE CUSTOMER, THE INSUFFLATOR IS WORKING ACCORDING TO THE EQUIPMENT'S SPECIFICATIONS. THE ISSUE THAT THEY HAVE IDENTIFIED IS A POTENTIAL USER ERROR WITH THE INSUFFLATOR. THE USER HAD THE PRESSURE AND THE FLOW SETTINGS MUCH HIGHER THAN HE SHOULD HAVE DURING THE ENDOSCOPIC VEIN HARVESTING. PER OUR COMPLAINT INVESTIGATION, THE CUSTOMER STATED: AFTER ENDOSCOPIC VEIN HARVESTING STARTED, THE PATIENT'S END TIDAL CO2 STARTED TO RISE. ANESTHESIA MACHINE SHOWED INCREASE IN ETCO2. PATIENT'S BLOOD GAS SHOWED AN INCREASE IN PCO2. EFFORTS WERE MADE TO CORRECT THE CO2, BUT IT DID NOT DECREASE UNTIL ABOUT 1.5 HOUR WHEN ENDOSCOPIC VEIN HARVESTING WAS FINISHING. ANESTHESIA MACHINE SETTINGS WERE CHANGED IN ORDER TO LOWER ETCO2 (INCREASE RESPIRATORY RATE AND CHANGED OUT ALL HOSES AND FILTERS ON MACHINE). INTERVENTIONS DIDN'T HELP INITIALLY. NO PATIENT IMPACT OR INJURY IDENTIFIED. CUSTOMER ALSO STATED THAT THEY AR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12870740 ↗
• InjuryNov 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE INITIAL COMPLAINT REPORT NOTED THE FOLLOWING: OUR THERMOFLATOR UNIT WAS USED FOR VEIN HARVESTING PROCEDURES ON (B)(6) OF 2021 (AND POTENTIALLY TWO MORE). THE UNIT IS IN OR15. SURGEON IN ALL 3 CASES WAS DR. (B)(6) . CUSTOMER DID NOT PROVIDE SPECIFIC INFORMATION ON THE INCIDENT. HOWEVER, PER THE CUSTOMER, THE INSUFFLATOR IS WORKING ACCORDING TO THE EQUIPMENT'S SPECIFICATIONS. THE ISSUE THAT THEY HAVE IDENTIFIED IS A POTENTIAL USER ERROR WITH THE INSUFFLATOR. THE USER HAD THE PRESSURE AND THE FLOW SETTINGS MUCH HIGHER THAN HE SHOULD HAVE DURING THE ENDOSCOPIC VEIN HARVESTING. PER OUR COMPLAINT INVESTIGATION, THE CUSTOMER STATED: AFTER ENDOSCOPIC VEIN HARVESTING STARTED, THE PATIENT'S END TIDAL CO2 STARTED TO RISE. ANESTHESIA MACHINE SHOWED INCREASE IN ETCO2. PATIENT'S BLOOD GAS SHOWED AN INCREASE IN PCO2. EFFORTS WERE MADE TO CORRECT THE CO2, BUT IT DID NOT DECREASE UNTIL ABOUT 1.5 HOUR WHEN ENDOSCOPIC VEIN HARVESTING WAS FINISHING. ANESTHESIA MACHINE SETTINGS WERE CHANGED IN ORDER TO LOWER ETCO2 (INCREASE RESPIRATORY RATE AND CHANGED OUT ALL HOSES AND FILTERS ON MACHINE). INTERVENTIONS DIDN'T HELP INITIALLY. NO PATIENT IMPACT OR INJURY IDENTIFIED. CUSTOMER ALSO STATED THAT THEY A

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12870738 ↗
• InjuryNov 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE INITIAL COMPLAINT REPORT NOTED THE FOLLOWING: OUR THERMOFLATOR UNIT WAS USED FOR VEIN HARVESTING PROCEDURES ON (B)(6) OF 2021 (AND POTENTIALLY TWO MORE). THE UNIT IS IN OR 15. SURGEON IN ALL 3 CASES WAS DR. (B)(6). CUSTOMER DID NOT PROVIDE SPECIFIC INFORMATION ON THE INCIDENT. HOWEVER, PER THE CUSTOMER, THE INSUFFLATOR IS WORKING ACCORDING TO THE EQUIPMENT'S SPECIFICATIONS. THE ISSUE THAT THEY HAVE IDENTIFIED IS A POTENTIAL USER ERROR WITH THE INSUFFLATOR. THE USER HAD THE PRESSURE AND THE FLOW SETTINGS MUCH HIGHER THAN HE SHOULD HAVE DURING THE ENDOSCOPIC VEIN HARVESTING. PER OUR COMPLAINT INVESTIGATION, THE CUSTOMER STATED: AFTER ENDOSCOPIC VEIN HARVESTING STARTED, THE PATIENT'S END TIDAL CO2 STARTED TO RISE. ANESTHESIA MACHINE SHOWED INCREASE IN ETCO2. PATIENT'S BLOOD GAS SHOWED AN INCREASE IN PCO2. EFFORTS WERE MADE TO CORRECT THE CO2, BUT IT DID NOT DECREASE UNTIL ABOUT 1.5 HOUR WHEN ENDOSCOPIC VEIN HARVESTING WAS FINISHING. ANESTHESIA MACHINE SETTINGS WERE CHANGED IN ORDER TO LOWER ETCO2 (INCREASE RESPIRATORY RATE AND CHANGED OUT ALL HOSES AND FILTERS ON MACHINE). INTERVENTIONS DIDN'T HELP INITIALLY. NO PATIENT IMPACT OR INJURY IDENTIFIED. CUSTOMER ALSO STATED THAT THEY A

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12870730 ↗
• MalfunctionJun 23, 2017Material Separation; Material Separation

  ALLEGEDLY, DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE THE DOCTOR NOTED THAT BOTH JAWS BROKE OFF THE INSTRUMENT AND FELL INTO THE PATIENT. THE DOCTOR USED ANOTHER BOWEL GRASPER FROM ANOTHER SET AND ONE OF THE JAWS BROKE OFF AS WELL. THE DOCTOR IMMEDIATELY RETRIEVED THE MISSING PIECES USING A STERILE MAGNET. NOTE: THIS REPORT PERTAINS TO THE SECOND INSTRUMENT THAT BROKE; A SEPARATE REPORT WAS FILED FOR THE FIRST INSTRUMENT THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6665621 ↗
• MalfunctionJun 23, 2017Material Separation; Material Separation

  ALLEGEDLY, DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE THE DOCTOR NOTED THAT BOTH JAWS BROKE OFF THE INSTRUMENT AND FELL INTO THE PATIENT. THE DOCTOR USED ANOTHER BOWEL GRASPER FROM ANOTHER SET AND ONE OF THE JAWS BROKE OFF AS WELL. THE DOCTOR IMMEDIATELY RETRIEVED THE MISSING PIECES USING A STERILE MAGNET. NOTE: THIS REPORT PERTAINS TO THE FIRST INSTRUMENT THAT BROKE; AS SEPARATE REPORT WILL BE FILED FOR THE SECOND INSTRUMENT THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6665615 ↗
• InjuryApr 7, 2017Device Operates Differently Than Expected

  ALLEGEDLY, THE PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE AND WHILE BEING INSUFFLATED, THE HOSPITAL CLAIMS THE THERMOFLATOR UNIT SOMEHOW CREATED A VACUUM SITUATION, CAUSING THE VERESS NEEDLE TO PERFORATE/LACERATE A BLOOD VESSEL, CREATING A HEMATOMA WHICH THEY WERE ABLE TO EVACUATE. THE PATIENT WAS ADMITTED OVERNIGHT AND WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Hematoma; Laceration(s)

  MAUDE report 6473587 ↗