Recall Z-0261-2025 ยท CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Ambu Inc.
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)
| Date | Oct 30, 2024 (initiated Sep 16, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction letter dated 9/24/24 was sent to customers. Advise on actions to be taken by user: Our records indicates that your facility has purchased the Ambu VivaSight 2 DLT products and you may have affected devices in your stock. Please identify if any of your in stock Ambu VivaSight 2 DLT products falls within the affected expiration date and lot numbers range listed on page 1 of this Field Safety Notice. If so, you must visually inspect these products as per below graphics before use to ensure that the distal end is not hyper-angulated. 1. View the blue tip of t |
| Quantity | 1824 |
| Distribution | US Nationwide. Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable Ambu A/S, May 3, 2021 |