Ambu recalls VivaSight 2 DLT endobronchial tube systems due to potential cuff leakage causing airway loss. Affected units have specific catalog numbers and UDI-DI codes. Contact Ambu for remedy.
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.
Ambu is recalling its VivaSight 2 DLT endobronchial tube systems because they may leak or rupture, risking loss of secure airway during medical procedures. This could require re-intubation of patients, which is serious.
The device's cuff may leak or rupture during medical procedures, leading to loss of secure airway. This could require re-intubation, which poses serious risks to patients.
Healthcare professionals using the VivaSight 2 DLT for verifying tube placement are most at risk. Patients receiving intubation procedures with this device could face complications.
Check for catalog numbers 412351000, 412371000, 412391000, or 412411000. The UDI-DI codes are 5707480145706, 5707480145737, 5707480145768, or 5707480145799.
Look for catalog numbers 412351000, 412371000, 412391000, or 412411000 on the product packaging.
Reach out to Ambu Inc. directly for instructions on how to return or replace the device.
The device may leak or rupture, causing loss of secure airway during procedures and requiring re-intubation of patients.
Catalog numbers 412351000, 412371000, 412391000, and 412411000 are affected.
Check the catalog number on the product packaging; affected units have specific catalog numbers and UDI-DI codes listed in the recall notice.
We’ve drafted a message you can send Ambu to request your refund or repair — edit it as you like.
Subject: Recall Z-1420-2022 — Ambu Ambu Hello, I own a Ambu that is covered by recall Z-1420-2022 from Ambu. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
