VivaSight™ 2 DLT Kit 35 Fr - LEFT 412351000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05707480145706), received between Aug 28, 2024 and Aug 28, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 3, 2022Class IIOpen, Classified

   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.

   Z-1420-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2024Difficult to Insert; Structural Problem; Difficult to Insert; Structural Problem

  ACCORDING TO INFORMATION FROM THE CUSTOMER. IN CONNECTION WITH INTUBATING WITH AMBU VIVASIGHT DOUBLE-LUMEN TUBE WITH CAMERA, DIFFICULT INTUBATION OCCURED. THE TUBE WAS HYPERANGULATED, WHICH MADE IT DIFFICULT TO PASS THE EPIGLOTTIS AND TRACHEA. THERE WAS BLEEDING AROUND THE EPIGLOTTIS, AND UPON EXTUBATION, BLOOD WAS SEEN ON THE CUFF AND THE TIP OF THE TUBE. ACCORDING TO FOLLOW-UP INFORMATION FROM THE CUSTOMER, THE PATIENT WAS FINE THE NEXT DAY AND DID NOT COMPLAIN ABOUT SORE THROAT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20088095 ↗
• MalfunctionAug 28, 2024Difficult to Insert; Structural Problem; Difficult to Insert; Structural Problem

  ACCORDING TO INFORMATION FROM THE CUSTOMER. IN CONNECTION WITH INTUBATING WITH AMBU VIVASIGHT DOUBLE-LUMEN TUBE WITH CAMERA, DIFFICULT INTUBATION OCCURED. THE TUBE WAS HYPERANGULATED, WHICH MADE IT DIFFICULT TO PASS THE EPIGLOTTIS AND TRACHEA. THERE WAS BLEEDING AROUND THE EPIGLOTTIS, AND UPON EXTUBATION, BLOOD WAS SEEN ON THE CUFF AND THE TIP OF THE TUBE. ACCORDING TO FOLLOW-UP INFORMATION FROM THE CUSTOMER, THE PATIENT WAS FINE THE NEXT DAY AND DID NOT COMPLAINT ABOUT SORE THROAT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20085639 ↗