AIRSEAL ASM-EVAC1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10845854045435), received between Jun 17, 2022 and Feb 9, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Defective Component” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026

  THE AIRSEAL WAS NOT INSUFFLATING, AND THE MESSAGE "OVERPRESSURE" WAS ALARMING FOR BOTH AIR SEAL TUBINGS. THE ROBOTIC AND GYN COORDINATORS WERE NOTIFIED AND THE AIRSEAL REP WAS CONTACTED WITH NO CALL BACK PER COORDINATOR. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290868 ↗
• MalfunctionFeb 9, 2026

  DURING THE SURGERY. THE AIRSEAL WAS NOT INSUFFLATING LIKE IT SHOULD HAVE BEEN AND THE MESSAGE "OVERPRESSURE" WAS ALARMING FOR THE AIRSEAL TUBING. ROBOTIC AND GYN COORDINATORS WERE NOTIFIED AND THE AIRSEAL REP. WAS CALLED WITH NO ANSWERS PER THE COORDINATOR. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290812 ↗
• MalfunctionJul 2, 2025Increase in Pressure; Defective Component

  WHILE USING THE AIRSEAL INSUFFLATOR, HIGH INSUFFLATION PRESSURE WAS NOTED. DESPITE THE MACHINE SAYING IT WAS VENTING THE OVERPRESSURE, THE PRESSURES DID NOT LOWER. ANOTHER MACHINE WAS BROUGHT TO THE ROOM WITH THE SAME RESULTS. NEW TUBING WAS USED WITH RESOLUTION OF THE PROBLEM, INDICATING THE TUBING WAS DEFECTIVE AND NOT THE MACHINE. NO DETECTABLE HARM WAS FOUND WITH THE PATIENT AND THE DEFECTIVE TUBING WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381961 ↗
• MalfunctionOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE ASM-EVAC1, TRILUMEN FILTERED TUBE SET, WAS BEING USED DURING A ROBOTIC RIGHT HEMI COLECTOMY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿THE AIRSEAL UNIT WAS SET TO A PRESSURE OF 12 PRIOR TO THE CASE. THEY BEGAN INSUFFLATION USING THE AIRSEAL TUBING AND A STANDARD APPLIED XL PORT. DURING THE INITIAL INSUFFLATION THEY NOTICED THAT THE ABDOMEN WAS VERY DISTENDED AND FIRM COMPARED TO USUAL. IT APPEARED THAT THERE WAS AN OVERLOAD OF GAS PRESSURE TO THE ABDOMEN. THEY NOTICED THE MACHINE WAS MAKING A WEIRD NOISE AND WAS FLUCTUATING AT A PRESSURE OF AROUND 5/6. IT DID NOT REACH AIRSEAL MODE. THE PORT TIP WAS UNDER VISUALISATION IN THE ABDOMEN, SO THEY CAN CONFIRM THE TIP WAS NOT IN THE TISSUE. THEY DECIDED TO STOP INSUFFLATION. THEY REMOVED THE TUBING AND OPENED A NEW ONE AND STARTED OVER. THE ABDOMEN INSUFFLATED AS NORMAL THE SECOND TIME AND THEY PROCEEDED WITH THE CASE. THE ANAESTHETIST COMMENTED THAT THEY WERE FINDING IT HARD TO MANAGE THE PATIENTS CO2 LEVELS AND NOTICED DURING THE CASE THAT THEIR FACE AND CHEST WAS PUFFY.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884711 ↗
• MalfunctionJun 17, 2022No Flow

  OPENED AIRSEAL TUBING FOR ROBOTIC CASE. TURNED ON INSUFFLATION, BUT THERE WAS NO CO2 FLOW. CHECKED CO2 CONNECTIONS. CALLED BIOMED. BIOMED IN OPERATING ROOM.

  Patient problems: Insufficient Information

  MAUDE report 14731275 ↗