AIRSEAL IAS5-100LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10845854045626), received between Apr 10, 2023 and May 15, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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-2471-2026 · 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.

• MalfunctionMay 15, 2026Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS5-100LP, 5 MM ACCESS PORT & LOW PROFILE OBTURATOR DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2026, AND ¿DURING THE OPERATION, THE PUNCTURE DEVICE BROKE AND FELL INTO THE BODY. THE ENTIRE SET HAD TO BE REPLACED.¿. FURTHER ASSESSMENT FOUND "THE TROCAR BROKE IN THE PATIENT" AND ALL FRAGMENTS WERE RETRIEVED BY HAND.". THE ASM-EVAC1 DEVICE DID NOT FRAGMENT OR FALL INTO THE PATIENT. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION 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 25185389 ↗
• MalfunctionMay 14, 2026Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS5-100LP, 5 MM ACCESS PORT & LOW-PROFILE OBTURATOR WAS BEING USED ON (B)(6) 26 AND ¿DURING SURGERY, THE DOUBLE CHAMBER OF THE 5 MM AIRSEAL TROCAR BROKE AND WE FOUND IT IN THE ABDOMINAL CAVITY.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT. PER FURTHER ASSESSMENT IT WAS REPORTED THAT THE TROCAR FRAGMENT WAS RETRIEVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE AND THERE WAS A 2-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 25169890 ↗
• MalfunctionApr 7, 2026Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS5-100LP, 5 MM ACCESS PORT & LOW PROFILE OBTURATOR DEVICE WAS USED DURING A GASTROINTESTINAL SURGERY ON (B)(6) 2026, AND ¿THE TROCAR BROKE WHILST BEING REMOVED FROM THE PATIENT'S ABDOMEN.¿. ALSO REPORTED WAS "EXTENDED PROCEDURE DURATION: PROLONGED SEDATION¿ AND ¿RECOVERY OF ALL BROKEN EQUIPMENT; VERIFICATION OF ALL COMPONENTS.¿. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION 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 24802404 ↗
• MalfunctionApr 28, 2023Material Fragmentation; Material Fragmentation

  UPDATE: THE PROCEDURE WAS CONFIRMED TO BE A HYSTERECTOMY. THE CUSTOMER REPORTED THAT THE DEVICE, IAS5-100LP, AIRSEAL 5/100MM PORT, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED "CRACKED". THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832389 ↗
• MalfunctionApr 10, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS5-100LP, AIRSEAL 5/100MM PORT WAS BEING USED ON (B)(6) 2023 AND ¿THE THREAD OF THE 5MM AIRSEAL TROCAR BROKE OFF WHEN BEING PULLED OUT OF THE PATIENT AND HAD TO BE REMOVED BY THE SURGEON.¿. THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 5 MINUTE DELAY. AN ALTERNATE DEVICE IAS-100LPI WAS USED. 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 16706786 ↗