VivaSight™ 2 DLT Kit 39 Fr - LEFT 412391000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05707480145768), received between Dec 5, 2024 and Feb 19, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Structural Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Inflation Problem

  DOCTOR ATTEMPTED STANDARD THORACIC PROCEDURE - INTUBATION OF A PATIENT USING VIVASIGHT 2 DLT. FIRST, THEY USED A 41FR AND THEN DOWNSIZED TO A 39FR. BOTH DLTS HAD THE CUFF BURST. CONSULTANT INFLATED THE CUFF WITH 2-3ML OF AIR AND THE CUFF WOULD NATURALLY DEFLATE. ADDITIONAL INFORMATION FROM THE HOSPITAL WAS PROVIDED BY THE DOCTOR: 'INTERMITTENTLY WE RUN INTO AN ISSUE IN WHICH DESPITE THE OPERATIVE LUNG BEING ISOLATED IT IS NOT DEFLATING WHEN OPENED TO AIR. CONDITION PERSISTS EVEN WITH APPLICATION OF DIRECT SUCTION. AIRWAY MANAGED DESPITE COMPROMISES TO THE SURGERY. MAY HAVE RESULTED IN THE NEED FOR LARGER INCISIONS AND EVEN UNNECESSARY THORACOTOMIES. TUBE CHANGED TO SHILEY BRONCOCATH OR BRONCHOSCOPE USED TO DOUBLE CHECK PLACEMENT DESPITE TUBE SEEMINGLY BEING WELL PLACED ACCORDING TO THE INBUILT CAMERA.'' IT IS NOT INDICATED THAT THE PATIENT EXPERIENCED ASSOCIATED HARM OF HYPOXIA, SINCE PATIENT'S AIRWAY WAS MANAGED. HOWEVER, DUE TO LACK OF INFORMATION ON THE COMPROMISES TO THE SURGERY, THE INCIDENT IS BEING REPORTED. NOTE THAT TWO REPORTS ARE BEING SUBMITTED DUE TO THE INVOLVEMENT OF TWO DEVICES. THE MANUFACTURER REFERENCE NUMBER OF THE SECOND REPORT IS 1220828-2026-00004.

  Patient problems: Insufficient Information

  MAUDE report 24393046 ↗
• MalfunctionFeb 19, 2026Inflation Problem

  DOCTOR ATTEMPTED STANDARD THORACIC PROCEDURE - INTUBATION OF A PATIENT USING VIVASIGHT 2 DLT. FIRST, THEY USED A 41FR AND THEN DOWNSIZED TO A 39FR. BOTH DLTS HAD THE CUFF BURST. CONSULTANT INFLATED THE CUFF WITH 2-3ML OF AIR AND THE CUFF WOULD NATURALLY DEFLATE. ADDITIONAL INFORMATION FROM THE HOSPITAL WAS PROVIDED BY THE DOCTOR: 'INTERMITTENTLY WE RUN INTO AN ISSUE IN WHICH DESPITE THE OPERATIVE LUNG BEING ISOLATED IT IS NOT DEFLATING WHEN OPENED TO AIR. CONDITION PERSISTS EVEN WITH APPLICATION OF DIRECT SUCTION. AIRWAY MANAGED DESPITE COMPROMISES TO THE SURGERY. MAY HAVE RESULTED IN THE NEED FOR LARGER INCISIONS AND EVEN UNNECESSARY THORACOTOMIES. TUBE CHANGED TO SHILEY BRONCOCATH OR BRONCHOSCOPE USED TO DOUBLE CHECK PLACEMENT DESPITE TUBE SEEMINGLY BEING WELL PLACED ACCORDING TO THE INBUILT CAMERA.'' IT IS NOT INDICATED THAT THE PATIENT EXPERIENCED ASSOCIATED HARM OF HYPOXIA, SINCE PATIENT'S AIRWAY WAS MANAGED. HOWEVER, DUE TO LACK OF INFORMATION ON THE COMPROMISES TO THE SURGERY, THE INCIDENT IS BEING REPORTED. NOTE THAT TWO REPORTS ARE BEING SUBMITTED DUE TO THE INVOLVEMENT OF TWO DEVICES. THE MANUFACTURER REFERENCE NUMBER OF THE SECOND REPORT IS 9610691-2026-00004.

  Patient problems: Insufficient Information

  MAUDE report 24387197 ↗
• InjuryDec 5, 2024Structural Problem; Structural Problem

  THE INCIDENT LEADING TO TONSIL INJURIES OCCURRED IN TWO SEPARATE PROCEDURES (THE SECOND INCIDENT IS COVERED BY 1220828-2024- 00024). A CRNA WAS TRYING TO INTUBATE WITH THE VIVASIGHT 2 DLT PRODUCT AND THEY HAD TO ADJUST THE DISTANCE OF TIP OF THE TUBE PAST THE VOCAL CORDS. THE CURVE AT THE END OF THE BRONCHIAL LUMEN WAS MORE ANGULATED THAN A TYPICAL ROBERT-SHAW DOUBLE LUMEN ENDOTRACHEAL TUBE, AND GOT MORE EASILY CAUGHT ON THE TRACHEAL RINGS. ONE COULD EITHER ADVANCE THE BRONCHIAL CUFF FURTHER PAST THE VOCAL CORDS WITH THE STYLET, OR IF THE STYLET WAS REMOVED AFTER THE TIP WAS IN THE TRACHEA, ONE COULD TURN THE TUBE 120-180 DEGREES LEFTWARD WHILE ADVANCING AND THEN RETURN IT TO 90 DEGREES ONCE PAST THE RING THAT THE TIP GOT HUNG UP ON.

  Patient problems: Upper Respiratory Tract Injury

  MAUDE report 20854058 ↗
• InjuryDec 5, 2024Structural Problem; Structural Problem

  THE INCIDENT LEADING TO TONSIL INJURIES OCCURRED IN TWO SEPARATE PROCEDURES (THE SECOND INCIDENT IS COVERED BY 1220828-2024-00025). A CRNA WAS TRYING TO INTUBATE WITH THE VIVASIGHT 2 DLT PRODUCT AND THEY HAD TO ADJUST THE DISTANCE OF TIP OF THE TUBE PAST THE VOCAL CORDS. THE CURVE AT THE END OF THE BRONCHIAL LUMEN WAS MORE ANGULATED THAN A TYPICAL ROBERT-SHAW DOUBLE LUMEN ENDOTRACHEAL TUBE, AND GOT MORE EASILY CAUGHT ON THE TRACHEAL RINGS. ONE COULD EITHER ADVANCE THE BRONCHIAL CUFF FURTHER PAST THE VOCAL CORDS WITH THE STYLET, OR IF THE STYLET WAS REMOVED AFTER THE TIP WAS IN THE TRACHEA, ONE COULD TURN THE TUBE 120-180 DEGREES LEFTWARD WHILE ADVANCING AND THEN RETURN IT TO 90 DEGREES ONCE PAST THE RING THAT THE TIP GOT HUNG UP ON.

  Patient problems: Aspiration Pneumonitis; Upper Respiratory Tract Injury

  MAUDE report 20853676 ↗
• InjuryDec 5, 2024Structural Problem; Structural Problem

  THE INCIDENT LEADING TO TONSIL INJURIES OCCURRED IN TWO SEPARATE PROCEDURES (THE SECOND INCIDENT IS COVERED BY 9610691-2024-00023). A CRNA WAS TRYING TO INTUBATE WITH THE VIVASIGHT 2 DLT PRODUCT AND THEY HAD TO ADJUST THE DISTANCE OF TIP OF THE TUBE PAST THE VOCAL CORDS. THE CURVE AT THE END OF THE BRONCHIAL LUMEN WAS MORE ANGULATED THAN A TYPICAL ROBERT-SHAW DOUBLE LUMEN ENDOTRACHEAL TUBE AND GOT MORE EASILY CAUGHT ON THE TRACHEAL RINGS. ONE COULD EITHER ADVANCE THE BRONCHIAL CUFF FURTHER PAST THE VOCAL CORDS WITH THE STYLET, OR IF THE STYLET WAS REMOVED AFTER THE TIP WAS IN THE TRACHEA, ONE COULD TURN THE TUBE 120-180 DEGREES LEFTWARD WHILE ADVANCING AND THEN RETURN IT TO 90 DEGREES ONCE PAST THE RING THAT THE TIP GOT HUNG UP ON.

  Patient problems: Upper Respiratory Tract Injury

  MAUDE report 20850556 ↗
• InjuryDec 5, 2024Structural Problem; Structural Problem

  THE INCIDENT LEADING TO TONSIL INJURIES OCCURRED IN TWO SEPARATE PROCEDURES (THE SECOND INCIDENT IS COVERED BY 9610691-2024-00024). A CRNA WAS TRYING TO INTUBATE WITH THE VIVASIGHT 2 DLT PRODUCT AND THEY HAD TO ADJUST THE DISTANCE OF TIP OF THE TUBE PAST THE VOCAL CORDS. THE CURVE AT THE END OF THE BRONCHIAL LUMEN WAS MORE ANGULATED THAN A TYPICAL ROBERT-SHAW DOUBLE LUMEN ENDOTRACHEAL TUBE, AND GOT MORE EASILY CAUGHT ON THE TRACHEAL RINGS. ONE COULD EITHER ADVANCE THE BRONCHIAL CUFF FURTHER PAST THE VOCAL CORDS WITH THE STYLET, OR IF THE STYLET WAS REMOVED AFTER THE TIP WAS IN THE TRACHEA, ONE COULD TURN THE TUBE 120-180 DEGREES LEFTWARD WHILE ADVANCING AND THEN RETURN IT TO 90 DEGREES ONCE PAST THE RING THAT THE TIP GOT HUNG UP ON.

  Patient problems: Aspiration Pneumonitis; Upper Respiratory Tract Injury

  MAUDE report 20850550 ↗