AIRSEAL IAS8-100LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10845854045718), received between Dec 7, 2021 and Feb 25, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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-2468-2026 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS8-100LP 8 MM ACCESS PORT & LOW PROFILE OBT W/BLADELESS OPTICAL TIP, WAS BEING USED ON (B)(6) 2026 DURING A ROBOTIC MASS EXCISION AND THE ¿SILICON PIECE FROM SOUND CAP FELL OFF AND INTO THE PATIENT'S ABDOMEN. THE PIECE WAS REMOVED FROM THE ABDOMEN.¿ THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITHOUT AN 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 24443912 ↗
• MalfunctionNov 28, 2025Increase in Pressure

  DURING THE SURGERY, THE AIRSEAL WAS USED BUT WAS NOT REGULATING PROPERLY OR WAS "OVER PRESSURED" AND NEEDING TO VENT. A NEW DEVICE WAS USED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671569 ↗
• MalfunctionApr 4, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, IAS8-100LP, 8 MM ACCESS PORT & LOW PROFILE OBT W/BLADELESS OPTICAL TIP, WAS BEING USED DURING A ROBOT ASSISTED LAP MYOMECTOMY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿MANUFACTURER DEFECT; ITEM QUALITY" AND "ONE PORTION OF INNER PLASTIC FOLDING PART BROKE OFF INTO SURGICAL SITE.¿. THERE WAS NO REPORTED INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT REQUESTED FOUND THAT THE FRAGMENTATION FELL INTO THE SURGICAL SITE AND WAS REMOVED WITH A ROBOTIC INSTRUMENT. THE FRAGMENTATION WAS NOT FROM A SOUND CAP. IT IS UNKNOWN WHAT CAUSED THE BREAKAGE AS THE FRAGMENTATION WAS ONLY SEEN DURING THE PROCEDURE WITHIN THE CAVITY. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORT OF 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 21771958 ↗
• MalfunctionNov 27, 2024Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER: (B)(4). THE ACCOUNT AND CONTACT INFORMATION FOR THIS REPORT ARE NOT KNOWN. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE IAS8-120LP, 8 MM ACCESS PORT & LOW-PROFILE OBTURATOR WAS BEING USED ON (B)(6) 2024 AND "AIR SEAL PLASTIC SEAL RIPPED AND PARTS OF IT WENT INTO PATIENT'S CAVITY. PLASTIC SEAL WAS RECOVERED BEFORE CLOSING OF THE CAVITY.". THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. THIS WAS REPORTED AS A DEVICE MALFUNCTION NOT AN ADVERSE EVENT. THE REPORTER REMAINED ANONYMOUS. 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 20795457 ↗
• MalfunctionJun 13, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS8-100LP, AIRSEAL 8/100MM PORT DEVICE WAS BEING USED DURING AN UNNAMED PROCEDURE ON APPROXIMATELY (B)(6) 2024, AND ¿TWO OF THE TROCARS FROM THE SAME BOX BOTH HAD ISSUES WITH THE SOUND CAP TEARING (ONE OF THEM FELL OFF ENTIRELY).¿ FOLLOW-UP ASSESSMENT CONFIRMED THAT IN ¿THE SECOND EVENT THE RUBBERY LINING OF THE CAP TORE OFF AND WAS DISCARDED.¿ ADDITIONALLY, THE DEVICE WAS ¿IN USE ON SURGICAL SITE HOWEVER UNABLE TO DETERMINE IF DIRECT CONTACT¿ WITH THE PATIENT; HOWEVER, THE EVENT REPORTEDLY OCCURRED ¿OUTSIDE OF THE PATIENT¿ AND ¿FRAGMENTS WERE RETRIEVED FROM STERILE FIELD NOT PATIENT CAVITY¿. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT AFTER THE SOUND CAP TORE AND FELL OFF. 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 19527220 ↗
• MalfunctionDec 1, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, IAS8-100LP, AIRSEAL 8/100MM PORT, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿IT WAS REPORTED THAT THE SOUND REDUCTION CAP WAS BROKEN.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. IN A FOLLOW UP REPORT ON 7NOV23, IT WAS ADVISED, ¿THE ACTUAL PRODUCT WAS CHECKED BY THE DISTRIBUTOR. IT WAS CONFIRMED THAT SOME OF THE SILICON WAS MISSING. THE FRAGMENTS WERE FOUND INSIDE THE BODY, AND ALTHOUGH IT IS UNCLEAR WHAT INSTRUMENT WAS USED, IT WAS SAID THAT THEY WERE REMOVED. ACCORDING TO THE DOCTOR, THE DEVICE THAT WAS INSERTED IS BELIEVED TO BE A CROCE OR MANCINA DEVICE.¿ AGAIN, THERE WAS NO REPORT OF INJURY OR IMPACT TO THE PATIENT. 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 18245184 ↗
• MalfunctionOct 9, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE IAS8-100LP, AIRSEAL 8/100MM PORT WAS BEING USED ON (B)(6) 2023 AND ¿WE JUST HAD AN 8 TROCAR THAT BROKE OFF IN A PATIENT'S ABDOMEN.¿. PER FURTHER ASSESSMENT THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. 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 17893927 ↗
• MalfunctionDec 7, 2021Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IAS8-100LP, AIRSEAL 8/100MM PORT, WAS BEING USED ON (B)(6) 2021 DURING A ROBOTIC HYSTERECTOMY PROCEDURE AND ¿A PIECE OF PLASTIC FROM THE SOUND CAP FELL INTO THE PATIENT DURING THE CASE. THEY WERE ABLE TO RETRIEVE THE PIECE AND NO INJURY WAS NOTED TO THE PATIENT.¿ AFTER FURTHER ASSESSMENT IT WAS FOUND, THE PROCEDURE WAS COMPLETED WITH A ONE TO TWO MINUTE DELAY. A BLUNT GRASPER WAS USED TO PULL/REMOVE COMPONENT OUT. NO MEDICAL/SURGICAL INTERVENTION REQUIRED. PATIENT STATUS IS NORMAL POST-OP RECOVERY AND THERE WAS NO EXTENDED STAY. 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 12950018 ↗