Ambu Inc.: Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)

Recall number

Z-0261-2025

Recalling firm

Ambu Inc.

Product

Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)

Status

Open, Classified

Initiated

2024-09-16

Posted

2024-10-30

Terminated

not on file

Reason

Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.

Root cause

Under Investigation by firm

Action

An Urgent Medical Device Correction letter dated 9/24/24 was sent to customers. Advise on actions to be taken by user: Our records indicates that your facility has purchased the Ambu VivaSight 2 DLT products and you may have affected devices in your stock. Please identify if any of your in stock Ambu VivaSight 2 DLT products falls within the affected expiration date and lot numbers range listed on page 1 of this Field Safety Notice. If so, you must visually inspect these products as per below graphics before use to ensure that the distal end is not hyper-angulated. 1. View the blue tip of the Vivasight 2. This can be done without taking the product out of the pouch. 2. Compare the angle (bend) of the tip with the pictures shown above. 3. The bend in the tip should be as shown like in Pictures 1 to 3. 4. If the bend is determined to be similar to Pictures 4, 5 or 6, they should not be used. If hyper-angulation is identified, you must discard the impacted Ambu VivaSight 2 DLT product. If your facility prefers not to inspect affected products and would like to return them, please indicate that on Appendix 1. Ambu will issue RMA Number for your return. Ambu will compensate you by either replacing the units with a new Ambu VivaSight 2 DLT, an aScope 4 broncho slim, which can be used with a conventional DLT or providing a credit. Please note that Ambu VivaSight 2 DLT products shipped from Ambu after September 04, 2024, should not be considered affected. Please return your confirmation of the actions described in the Field Safety Notice (Appendix 1) within 2 weeks of receipt of this letter. Transmission of this Field Safety Notice: This notice needs to be passed on to all those who need to be aware within your organization and/or to any organization where the devices could have been transferred/shipped. Please forward this notice to other organizations on which this action may have an impact. Also, please maintain awareness on this notice and resulting action f

Quantity

1824

Distribution

US Nationwide. Canada.

Lot, serial or model codes

Lot Codes: VivaSight 2 DLT Kit 35 Fr - lot no. 1000891667 to lot. no 1001021855; VivaSight 2 DLT Kit 37 Fr - lot. no. 1000887909 to lot no. 1001021861; VivaSight 2 DLT Kit 39 Fr - lot. no. 1000916871 to lot no. 1001021917; VivaSight 2 DLT Kit 41 Fr - lot. no. 1000934084 to lot. no. 1001011434

510(k) numbers

["K203749"]

PMA numbers

not on file

Product code

CBI

Firm FEI

1121788

Firm city

Columbia

Firm state

MD

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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