Class 2 Device Recall Ambu VivaSight 2 DLT

• Date Initiated by Firm: June 03, 2022
• Create Date: July 20, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1420-2022
• Recall Event ID: 90488
• 510(K)Number: K203749
• Product Classification: Tube, tracheal/bronchial, differential ventilation (w/wo connector) - Product Code CBI
• Product: Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
• Code Information: Catalog No: 412351000 UDI-DI: 5707480145706 1 each 5707480145713 5 pc/pack Catalog No. 412371000 UDI-DI: 5707480145737 1 each 5707480145744 5 pc/pack Catalog No. 412391000 UDI-DI: 5707480145768 1 each 5707480145775 5 pc/pack Catalog No. 412411000 UDI-DI: 5707480145799 1 each 5707480145805 5 pc/pack All lots
• Recalling Firm/ Manufacturer: Ambu Inc.; 6230 Old Dobbin Ln Ste 250; Columbia MD 21045-5955
• For Additional Information Contact: Tammy Feyerherm; 800-262-8462
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 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 Canada, Australia, New Zealand, Israel .
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CBI