LMA IPN042417Recalls & reported problems
Teleflex Incorporated · LMA Fastrach™ SU ETT 8.0mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060112310591), received between Jul 21, 2023 and Jul 21, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Airway Obstruction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT "PATIENT (60 YEARS OLD MALE) WAS PRONE FOR PROCEDURE WITH A REINFORCED TUBE IN SITU, NO CONCERNS ON INTUBATING, WHEN THEY WERE MOVING PATIENT FROM PRONE TO SUPINE, THE AIRWAY CAME OUT OF PATIENT, CAUSING AN AIRWAY OBSTRUCTION AND DIFFICULTY IN VENTILATING DESPITE THE BALLOON BEING INFLATED AS PER POLICY. THE PATIENT WAS VENTILATED AND REINTUBATED WITH ANOTHER ET TUBE, NO HARM CAME TO THE PATIENT." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: Airway Obstruction
MAUDE report 17372288 ↗
Other Tube, tracheal (w/wo connector) devices
- Shiley 18875Covidien LP · Tube, tracheal (w/wo connector)4 deaths570 reports
- RUSCH IPN041476Teleflex Incorporated · Tube, tracheal (w/wo connector)10 recalls0 reports
- Shiley 18775Covidien LP · Tube, tracheal (w/wo connector)489 reports
- Shiley 18770Covidien LP · Tube, tracheal (w/wo connector)2 deaths434 reports
- Shiley 18880Covidien LP · Tube, tracheal (w/wo connector)2 deaths370 reports
- Shiley 18780Covidien LP · Tube, tracheal (w/wo connector)3 deaths286 reports
- Shiley 18770SCovidien LP · Tube, tracheal (w/wo connector)273 reports
- Shiley 18780SCovidien LP · Tube, tracheal (w/wo connector)251 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page