The Recall Desk
HighFDA (Devices)·Z-1420-2022·Announced 2022-07-27

Ambu VivaSight 2 DLT endobronchial tubes recalled for cuff leak risk

Ambu Inc. is recalling the VivaSight 2 DLT endobronchial tube system due to reports of cuff leaks or ruptures that could compromise airway security during intubation procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device with a reported risk of cuff failure leading to airway compromise during critical procedures. No injuries have been reported to date. The recall meets the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ambu Inc. is recalling 12,921 units of the Ambu VivaSight 2 DLT (double-lumen tube) endobronchial tube system. The device is used for verifying proper tube placement and repositioning during intubation procedures.

The company has received complaints that the bronchial or tracheal cuff may leak or rupture during use. If the cuff integrity is compromised, the patient could lose a secure airway and require emergency re-intubation.

The recall affects all lots of the affected catalog numbers: 412351000, 412371000, 412391000, and 412411000. The device has been distributed nationwide in the United States and internationally, including to Austria, Belgium, Canada, Australia, New Zealand, Israel, and numerous European countries.

The recalled product

Product
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Manufacturer
Ambu Inc.
Category
Medical Device — Airway Management
Hazard
  • cuff-leak-rupture
  • airway-compromise

Distribution

Distributed nationwide across the United States.

Related recalls

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