Z-1420-2022Class II

Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog...

Name: Z-1420-2022 Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog...
Creator: Ambu Inc.
Published: 2022-06-03
License: https://open.fda.gov/license/

Ambu Inc. / initiated 2022-06-03 / Open, Classified

FDA source

Ambu Inc. began a recall of Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000 on 2022-06-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1420-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-03
Posted: 2022-07-20
Recalling firm: Ambu Inc.
Product: Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Product code: CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
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 root 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 .
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1420-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1420-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20

Product code CBI

K203749Class IIAmbu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableAmbu A/S / cleared 2021-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)