Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Check against the official notice below — it lists the full affected range.
Ambu Inc. is recalling the Ambu VivaSight 2 DLT endobronchial tube system due to reports of leaks or ruptures in either the bronchial or tracheal cuff. The affected devices include catalog numbers 412351000, 412371000, 412391000, and 412411000. If a cuff leaks during a procedure, it can cause loss of a secure airway and require the patient to be re-intubated.
A total of 12,921 units have been distributed nationwide in the United States and internationally to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, the United Kingdom, Canada, Australia, New Zealand, and Israel. The recall covers all lots of the affected catalog numbers. The source document does not specify what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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 . Quantity: 12,921 Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.