Ambu VivaSight 2 DLT recallZ-1420-2022 · Ambu Inc. · initiated Jun 3, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ambu Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1420-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 3, 2022
- Recalling firm
- Ambu Inc.
- Quantity
- 12,921
- Product code
- CBI
- FDA submissions
- K203749
- 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 .
Product description
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Code information (models, lots, serial numbers)
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
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- VivaSight™ 2 DLT Kit 37 Fr - LEFT 412371000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall10 reports
- VivaSight™ 2 DLT Kit 39 Fr - LEFT 412391000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall6 reports
- VivaSight™ 2 DLT Kit 35 Fr - LEFT 412351000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall2 reports
- VivaSight™ 2 DLT Kit 41 Fr - LEFT 412411000Ambu A/S · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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