Skip to content
Recall Observatory FDA recall evidence

Device product

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)

Z-0261-2025

September 16, 2024

Class II

Product summary

Firm
Ambu Inc.
Event
Event 95454
Status
Ongoing
Classification
Class II
Quantity
1824
Official record key
device-enforcement:Z-0261-2025

Official wording

Reason: 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.

Code information: Lot Codes: VivaSight 2 DLT Kit 35 Fr - lot no. 1000891667 to lot. no 1001021855; VivaSight 2 DLT Kit 37 Fr - lot. no. 1000887909 to lot no. 1001021861; VivaSight 2 DLT Kit 39 Fr - lot. no. 1000916871 to lot no. 1001021917; VivaSight 2 DLT Kit 41 Fr - lot. no. 1000934084 to lot. no. 1001011434

Distribution pattern: US Nationwide. Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.