Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
FDA Recall Z-1420-2022 · Posted None
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Recalling FirmAmbu Inc.
Recall StatusOpen, Classified
Product CodeCBI
Date Initiated2022-06-03
Product Quantity12,921
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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 .
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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