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RUSCH IPN041703Recalls & reported problems

Teleflex Incorporated · BRONCHIAL DOUBLE LUMEN TUBE SET (LEFT), STERILE · Class 2

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 14026704344250), received between Nov 10, 2022 and Nov 10, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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

Device problems

  • Gas/Air Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 10, 2022Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED THAT THE DOCTOR FOUND A CUFF LEAK WHILE IN USE ON THE PATIENT. THE DOCTOR CHANGED TO A NEW TUBE. THE PATIENT DID NOT EXPERIENCE ANY DESATURATION. NO REPORT OF PATIENT HARM OR INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15771386 ↗

Other TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) devices

All TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.