AirLife™ CSC114TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752140639), received between Oct 3, 2025 and Oct 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED: DURING SUCTIONING OF A TRACHEOSTOMIZED PATIENT, WITH A CLOSED SUCTION CATHETER (CSC), THE TUBE SPLIT INSIDE THE PROTECTIVE PLASTIC SHEATH AND BECAME AIR-FILLED. AT THE TIME OF THE EVENT, APPROXIMATELY 8-10 CM OF THE CATHETER WAS INSIDE THE TRACHEA. THE CSC WAS REPLACED WITH A NEW ONE; A NON-SERIOUS INJURY WAS REPORTED. ANY COMPONENT THAT IS PART OF THE VENT CIRCUIT (FLEX CONNECTOR, DOUBLE SWIVEL ELBOW, Y-ADAPTER, T-PIECE, ETT ADAPTER, ETC.) BREAKS, CRACKS, OR LEAKS AFTER THE VENT CIRCUIT HAS BEEN ESTABLISHED ON THE PATIENT. AND WHICH REQUIRES A REPLACEMENT ETT COULD CAUSE OR LEAD TO A SERIOUS INJURY. THE REPORTABILITY OF THIS COMPLAINT WAS DETERMINED BASED ON REVIEW OF THE COMPLAINT BY THE AERB TEAM ON 10 SEP 2025; (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213756 ↗