Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Anesthesiology · 21 CFR 868.5740
Recent MDR events
1,573 adverse event reports on file
- EZ-BLOCKER KITJul 29, 2026MalfunctionTeleflex Medical3006425876-2026-00811
- ET TUBE, SHER-I-BRONCH, LS, 35 FRJul 13, 2026MalfunctionTeleflex Medical3003898360-2026-00323
- ET TUBE, SHER-I-BRONCH, LS, 35 FRJul 13, 2026MalfunctionTeleflex Medical3003898360-2026-00297
- ET TUBE, SHER-I-BRONCH, LS, 35 FRJul 13, 2026MalfunctionTeleflex Medical3003898360-2026-00295
- PARKERJul 10, 2026MalfunctionParker Medical3004748541-2026-00134
- ET TUBE, SHER-I-BRONCH, LS, 35 FRJul 7, 2026MalfunctionTeleflex Medical3003898360-2026-00328
- ET TUBE, SHER-I-BRONCH, LS, 37 FRJul 1, 2026MalfunctionTeleflex Medical3003898360-2026-00285
- ARNDT ENDOBRONCHIAL BLOCKER SETJun 30, 2026MalfunctionCook Inc1820334-2026-00697
- EZ-BLOCKER KITMay 18, 2026MalfunctionTeleflex Medical3006425876-2026-00528
- ARNDT ENDOBRONCHIAL BLOCKERMay 15, 2026MalfunctionCook Inc1820334-2026-00517
Event type breakdown
Recalls
10 recall events for this product code
- Ambu Inc.Open, ClassifiedOct 30, 2024
Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Nu
Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.
Z-0261-2025 · View FDA record ↗ - Parker MedicalTerminatedMar 3, 2017
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-
The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
Z-1399-2017 · View FDA record ↗ - Teleflex MedicalTerminatedAug 20, 2015
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile.
The double swivel connector may crack or separate on the endobronchial tube.
Z-2367-2015 · View FDA record ↗ - Teleflex MedicalTerminatedAug 20, 2015
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile.
The double swivel connector may crack or separate on the endobronchial tube.
Z-2368-2015 · View FDA record ↗ - Teleflex MedicalTerminatedAug 20, 2015
HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile.
The double swivel connector may crack or separate on the endobronchial tube.
Z-2369-2015 · View FDA record ↗ - Teleflex MedicalTerminatedAug 20, 2015
HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile.
The double swivel connector may crack or separate on the endobronchial tube.
Z-2370-2015 · View FDA record ↗ - Teleflex MedicalTerminatedApr 6, 2005
Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; Hudson Re
The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-16137 stating 'Bronchial - Left' instead of 'Bronchial - Right'.
Z-0680-05 · View FDA record ↗ - Teleflex MedicalTerminatedApr 6, 2005
Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial i
The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-16137 stating 'Bronchial - Left' instead of 'Bronchial - Right'.
Z-0681-05 · View FDA record ↗ - Teleflex MedicalTerminatedUnknown
HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, broc
The tracheal and brochial swivel connectors are incorrectly labeled.
Z-0703-2020 · View FDA record ↗ - Ambu Inc.Open, ClassifiedUnknown
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000,
Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.
Z-1420-2022 · View FDA record ↗
Registered firms
56 firms currently registered for this product code
Sterigenics Us Llc
Grand Prairie, TX, US
Covidien
Lafayette, CO, US
Arrow International C.r. A.s.
ZDAR NAD SAZAVOU Vysocina, CZ
Steris Ast Cz S.r.o.
VELKA BITES Vysocina, CZ
Synergy Sterilisation (m) Sdn Bhd
Kuala Ketil Kedah, MY
Insung Medical Co., Ltd.
WONJU-SI Gangwon, KR
Fuji Systems Corporation, Shin-shirakawa Plant
Shirakawa Fukushima, JP
Sterigenics Us Llc
Gurnee, IL, US
Teleflex Medical Llc
Morrisville, NC, US
Fuji Systems Corporation, Shirakawa Plant
Nishi Shirakawa Gun Fukushima, JP
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Shenzhen Insighters Medical Technology Co., Ltd.
Shenzhen Guangdong, CN
Icu Medical, Inc.
SAN CLEMENTE, CA, US
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Sterigenics Us Llc
Los Angeles, CA, US
Hangzhou Tappa Medical Technology Co., Ltd.
Hangzhou Zhejiang, CN
Cook Incorporated
Bloomington, IN, US
Ups Supply Chain Solutions, Inc.
Louisville, KY, US
Henan Tuoren Medical Device Co., Ltd.
Changyuan Henan, CN
Pulmonx, Corp.
Redwood City, CA, US
Bbf Sterilisationsservice Gmbh
Kernen Baden-Wurttemberg, DE
Icu Medical Healthcare Manufacturing S.a. De C.v.
Tijuana, B.C. C.P. Baja California, MX
510(k) clearances
34 clearances for this product code
- Hangzhou Tappa Medical Technology Co., Ltd.Mar 20, 2026
K251950 · Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)
- Pulmonx CorporationFeb 13, 2026
K253096 · Chartis Precision Catheter
- Shenzhen Insighters Medical Technology Co., Ltd.May 13, 2024
K232529 · Disposable Double Lumen Endobronchial Tube
- Shenzhen Insighters Medical Technology Co., Ltd.Dec 14, 2023
K232580 · Disposable Endobronchial Blocker Tube
- Pulmonx CorporationDec 1, 2022
K222340 · Chartis Precision Catheter
- Hytek Medical, Inc.Aug 10, 2021
K201026 · sOLVe Tube
- Ambu A/SMay 3, 2021
K203749 · Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
- Insung Medical Co., Ltd.Dec 28, 2020
K200968 · ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R