Recall Z-1420-2022 ยท CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Ambu Inc.
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
| Date | Jun 3, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | On June 3, 2022, the firm notified customers of the recall through email. Customers were instructed to discard their affected product and report the amount back to the firm. The firm will provide replacement product or credit to affected customers. |
| Quantity | 12,921 |
| Distribution | Domestic distribution nationwide. Foreign distribution to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norge, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK Can |
| 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 |