AIRSEAL IAS12-150LPiRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10845854052006), received between Mar 2, 2023 and Aug 2, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 14, 2026Class IIOpen, Classified

   Potential for overpressure alerts.

   Z-2472-2026 · Root cause: Process change control · Recall details · FDA record ↗

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.

• MalfunctionAug 2, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS12-150LPI, AIRSEAL 12/150MM LPI PORT WAS BEING USED DURING A VIDEO ASSISTED THORACIC SURGERY ON (B)(6) 2024 AND ¿I WAS RECENTLY MADE AWARE OF AN INCIDENT ON (B)(6) 2024 AT (B)(6) HOSPITAL WHERE A CORNER OF THE RUBBER VALVE ON THE SOUND CAP OF AN AIRSEAL 12MM TROCAR RIPPED OFF AND WAS FOUND IN THE PATIENT¿S ABDOMEN. THE CIRCULATION NURSE REPORTS THAT THE RUBBER VALVE RIPPED AFTER INSERTING AND REMOVING A STAPLER FROM THE TROCAR. THEY ALSO REPORT THEY HAVE BEEN OPERATING WITH THE SAME STAPLER FOR A YEAR AND THIS HAS NOT HAPPENED BEFORE. I HAVE RECOMMENDED TO THE ACCOUNT THAT THEY SHOULD REMOVE THE SOUND CAP BEFORE INSERTING THE STAPLER OR REMOVING SPECIMEN¿¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT THE FRAGMENT WAS RETRIEVED AND ¿THE PATIENT IS FINE, NO HARM DONE TO THE PATIENT.¿. THERE WAS NO EXTENDED STAY AT THE HOSPITAL FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 5 MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19892230 ↗
• MalfunctionAug 21, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS12-150LPI, AIRSEAL 12/150MM LPI PORT, WAS BEING USED DURING A GYNECOLOGICAL ROBOT PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿THE CUSTOMER NOTICED THAT AT THE END OF THE GYNECOLOGICAL ROBOT PROCEDURE, A PIECE OF THE EXTERNAL DOUBLE-WALLED CANNULA WAS MISSING. AFTER SEARCHING INSIDE THE ABDOMEN, THEY FOUND THE PIECE OF PLASTIC.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED. ALL FRAGMENTATION WAS RECOVERED FROM THE PATIENT PER THE REPORTER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583219 ↗
• MalfunctionAug 21, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS12-150LPI, AIRSEAL 12/150MM LPI PORT, WAS BEING USED DURING A GYNECOLOGICAL ROBOT PROCEDURE ON (B)(6) 2023, WHEN IT WAS REPORTED, ¿THE CUSTOMER NOTICED THAT AT THE END OF THE GYNECOLOGICAL ROBOT PROCEDURE, A PIECE OF THE EXTERNAL DOUBLE-WALLED CANNULA WAS MISSING. AFTER SEARCHING INSIDE THE ABDOMEN, THEY FOUND THE PIECE OF PLASTIC.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED. ALL FRAGMENTATION WAS RECOVERED FROM THE PATIENT PER THE REPORTER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583216 ↗
• MalfunctionMay 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS12-150LPI, AIRSEAL 12/150MM LPI PORT WAS BEING USED ON (B)(6) 2023 DURING A ROBOTIC PARTIAL NEPHRECTOMY AND ¿THE CONMED/AIRSEAL REP WAS PRESENT DURING THIS CASE. THE STAFF WAS USING A CLIP APPLIER INSTRUMENT THROUGH THE IAS12-150LPI AND NOTICED THAT ONE OF THE BLUE PLASTIC FLAPS FROM THE NOISE REDUCTION CAP HAD BECOME DISLODGED FROM THE WHITE CAP HOUSING AND WAS LAYING INSIDE THE ABDOMINAL CAVITY. THIS FLAP WAS RETRIEVED WITH A GRASPER AND REMOVED FROM THE PATIENT. SURGEON DR. SAID THERE WAS NO INJURY TO PATIENT. THE SURGICAL ASSIST WHO WAS HANDLING THE CLIP APPLIER AND PUTTING IT THROUGH THE AIRSEAL PORT, SAID THAT PERHAPS THE BUSINESS END OF THE CLIP APPLIER INSTRUMENT HAD GOTTEN CAUGHT ON THIS BLUE PLASTIC FLAP AND PERHAPS DISLODGED IT. HE NOTICED A PUNCTURE HOLE/MARK ON THE BLUE FLAP.¿. THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877855 ↗
• MalfunctionMar 2, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE IAS12-150LPI AIRSEAL 12/150MM LPI PORT WAS BEING USED (B)(6) 2023 AND ¿THE BLUE PLASTIC FELL OFF OF THE SOUNDCAP AND INTO THE PATIENT'S ABDOMEN DURING THE CASE. THEY STATED THAT THIS WAS DURING A ROBOTIC CASE BUT CANNOT REMEMBER WHAT INSTRUMENT WAS USED DOWN THE AS PORT. THEY STATED THAT THEY WERE ABLE TO RETRIEVE THE PIECE OF PLASTIC AND THAT THE PATIENT WAS OK.¿ THERE WAS NO REPORT OF INJURY OR IMPACT FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16467048 ↗