FDA-Device2024-11-06Class II
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
Ambu Inc.
Hazard
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.
Sold states
US Nationwide. Canada.
Affected count
1824
Manufactured in
6721 Columbia Gateway Dr Ste 200, N/A, Columbia, MD, United States
Products
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0261-2025Don't want to check this manually?
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