SHERIDAN 5-16028Recalls & reported problems
Teleflex Incorporated · ET TUBE, SHER-I-BRONCH, LS, 28 FR · Class 2
All models of SHERIDAN (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14026704941152), received between Dec 24, 2025 and Dec 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Too Soft/Flexible” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Too Soft/Flexible1
Patient problems
- Upper Respiratory Tract Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 24, 2025Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED THAT: "ANAESTHESIOLOGIST COMPLAINED THAT THE MATERIAL OF TUBE WAS TOO SOFT AND COULD NOT HOLD THE STRENGTH. CHANGE TWO 35FR_TUBES & ONE 28FR_TUBE AND COULD NOT BUILD THE AIRWAY. TRIED BLOCKER AND BUILT-UP PATIENT AIRWAY. TRACHEAL RUPTURE DURING INTUBATION AND PLACED TRACHEAL STENT." ASSOCIATED COMPLAINTS 3003898360-2025-00933 AND 3003898360-2025-00935.
Patient problems: Upper Respiratory Tract Injury
MAUDE report 23887268 ↗
Other TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) devices
- HUDSON RCI IPN048996Teleflex Incorporated · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)64 reports
- VivaSight™ 2 DLT Kit 37 Fr - LEFT 412371000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall10 reports
- HUDSON RCI IPN048995Teleflex Incorporated · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)58 reports
- VivaSight™ 2 DLT Kit 39 Fr - LEFT 412391000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall6 reports
- VivaSight™ 2 DLT Kit 35 Fr - LEFT 412351000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall2 reports
- VivaSight™ 2 DLT Kit 41 Fr - LEFT 412411000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall2 reports
- Portex 198-35LIcu Medical, Inc. · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)48 reports
- Portex 198-37LIcu Medical, Inc. · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)44 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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