AIRSEAL IAS5-120LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10845854045657), received between Dec 27, 2022 and May 28, 2026 — classified as 1 injury, 3 malfunctions.

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

2 FDA recall records name this device's identifier, 2 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-2467-2026 · Root cause: Process change control · Recall details · FDA record ↗

2. May 14, 2026Class IIOpen, Classified

   Potential for overpressure alerts.

   Z-2470-2026 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE IAS5-120LP, 5 MM ACCESS PORT & LOW-PROFILE OBTURATOR WAS BEING USED ON (B)(6) 2026 DURING A HYSTERECTOMY AND THE ¿CANNULA BROKE MIDWAY UP TO THE SHAFT OUTER LUMEN CRACKED WITH SMALL 2X8 PIECE MISSING. MISSING PIECE COULD NOT BE LOCATED. X-RAY TAKEN WITHOUT IDENTIFICATION OF PIECE IN PATIENT ABDOMEN.¿ PER FURTHER ASSESSMENT IT WAS REPORTED "WE CANNOT CONFIRM WHETHER OR NOT THE FRAGMENT OF THE CANNULA WAS RETAINED OR NOT RETAINED WITHIN THE PATIENT. A KUB INTRAOPERATIVE X-RAY WAS TAKEN IN AN ATTEMPT TO LOCATE THE FRAGMENT. HOWEVER, CONFIDENCE WAS LOW FOR SEEING THE FRAGMENT ON RADIOGRAPHY DUE TO THE LACK OF OR LIMITED RADIOPACITY OF THE MATERIAL AND SMALL SIZE OF THE FRAGMENT. THE PIECE COULD POSSIBLY HAVE BEEN RETAINED." THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN DEVICE. THERE WAS A 60 TO 90-MINUTE DELAY TO THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PATIENT COULD POSSIBLY HAVE RETAINED A DEVICE FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25316322 ↗
• MalfunctionApr 30, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS5-120LP, 5 MM ACCESS PORT & LOW-PROFILE DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿THE OUTER CANULA OF THE TROCAR BROKE IN HALF AND A PIECE FELL INTO THE PATIENT¿S ABDOMEN. ALL OF THE PIECES WERE RETRIEVED FROM THE PATIENT WITH NO INJURY. THERE WAS A 5-10 MINUTE DELAY FOR RETRIEVAL.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 21933476 ↗
• MalfunctionFeb 21, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE IAS5-120LP, AIRSEAL 5/120MM PORT WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿THE OUTER DIAMETER OF IAS5-120LP WHICH IS A PLASTIC PIECE BROKE OFF AND FELL INTO THE PATIENT DURING SURGERY. THE ITEM WAS RETRIEVED WITH NO INJURY TO THE PATIENT WITH MINIMAL DELAY.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE, AND MINIMAL DELAY WAS REPORTED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751231 ↗
• MalfunctionDec 27, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IAS5-120LP, AIRSEAL 5/120MM PORT WAS BEING USED ON 7DEC22 DURING A FIBROID HYSTERECTOMY PROCEDURE AND ¿DR. WAS ASSISTING ME IN A FIBROID HYSTERECTOMY TURNED ADVANCED ENDOMETRIOSIS CASE YESTERDAY IN THE RICHMOND OR. WE WERE USING THE AIRSEAL SYSTEM FOR INSUFFLATION. WHILE IT WAS A DIFFICULT CASE, THERE WAS NOT UNDUE TORQUE OR PRESSURE PLACED ON THE AIRSEAL TROCAR. ABOUT 4 HOURS INTO THE CASE WE SUDDENLY LOST INSUFFLATION AND AN ERROR MESSAGE OCCURRED WITH THE MACHINE. WE RESTARTED THE AIRSEAL SYSTEM BUT IT TOOK TOO LONG ¿ 5 MINUTES?- TO INITIALIZE SO WE DECIDED TO MOVE TO CONVENTIONAL INSUFFLATION. SHORTLY THEREAFTER THE INNER TUBE AND EXTERNAL PORTION OF THE PORT FELL OUT OF THE ABDOMEN. WHEN I PICKED IT UP I REALIZED THERE WAS A PIECE MISSING. WE SEARCHED THE ABDOMEN AND FOUND IT IN THE RIGHT UPPER QUADRANT. DR. WAS ABLE TO REMOVE THE PIECE THROUGH THE OPEN VAGINAL CUFF AND PUZZLE-PIECE IT WITH THE PORTION THAT FELL OUT TO CONFIRM THERE WERE NO SHARDS IN THE ABDOMEN. WE COMPLETED THE CASE WITH CONVENTIONAL INSUFFLATION.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE AIRSEAL WILL BE LISTED AS A CONCOM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050324 ↗