VivaSight™ 2 DLT Kit 37 Fr - LEFT 412371000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05707480145737), received between Mar 10, 2022 and Feb 26, 2026 — classified as 4 injuries, 6 malfunctions.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Product Quality Problem

  COULDN'T PASS SUCTION CATHETER DOWN THE TUBE. CATHETER BENDING BACK ON ITSELF WHEN HITTING THE INNER LUMEN OF DLT. APPLIED LUBRICANT TO CATHETER BUT IT MADE NO DIFFERENCE. ADDITIONAL INFORMATION RECEIVED: · PROCEDURE STARTED ~20 MINUTES LATE BECAUSE THE SUCTION CATHETER COULDN'T BE PASSED DOWN THE LUMEN. HAD TO OPEN X3 DIFFERENT CATHETERS TO REMOVE SECRETIONS (AMBU COMMENT: THE FIRST ISSUE/COMPLINT FOR THE REPORTED EVENT). · PROCEDURE HAD TO BE STOPPED MULTIPLE TIMES AS THE LUNG WAS NOT DEFLATING. SURGEONS UTILIZED THEIR TOOLS TO SQUEEZE THE LUNG BUT THIS WOULD ONLY STAY FLAT FOR A SHORT AMOUNT OF TIME. TO CIRCUMNAVIGATE THIS, THE CONSULTANT WOULD TURN OFF VENTILATION COMPLETELY, EFFECTIVELY MAKING THE PATIENT APNEIC. SHE WOULD TURN IT BACK ON AFTER A MINUTE AND CONTINUE FLUCTUATING ON BILATERAL AND ONE LUNG VENTILATION (AMBU COMMENT: THE SECOND ISSUE/COMPLAINT FOR THE REPORTED EVENT. A NON-DEFLATING LUNG IS MOST COMMONLY CAUSED BY MALPOSITION OF THE TUBE OR BY PATIENT RELATED FACTORS). · THE PROCEDURE HAD TO BE STOPPED, WITH THE DLT REMOVED AND A STANDARD ETT REPLACING IT. THEY THEN WANTED TO SEND THE PATIENT OFF FOR A SCAN, BEFORE DETERMINING IF THEY NEEDED TO DO AN OPEN CHEST PR

  Patient problems: Hypoxia

  MAUDE report 24458481 ↗
• InjuryFeb 26, 2026Product Quality Problem

  COULDN'T PASS SUCTION CATHETER DOWN THE TUBE. CATHETER BENDING BACK ON ITSELF WHEN HITTING THE INNER LUMEN OF DLT. APPLIED LUBRICANT TO CATHETER BUT IT MADE NO DIFFERENCE. ADDITIONAL INFORMATION RECEIVED: · PROCEDURE STARTED ~20 MINUTES LATE BECAUSE THE SUCTION CATHETER COULDN'T BE PASSED DOWN THE LUMEN. HAD TO OPEN X3 DIFFERENT CATHETERS TO REMOVE SECRETIONS (AMBU COMMENT: THE FIRST ISSUE/COMPLINT FOR THE REPORTED EVENT). · PROCEDURE HAD TO BE STOPPED MULTIPLE TIMES AS THE LUNG WAS NOT DEFLATING. SURGEONS UTILIZED THEIR TOOLS TO SQUEEZE THE LUNG BUT THIS WOULD ONLY STAY FLAT FOR A SHORT AMOUNT OF TIME. TO CIRCUMNAVIGATE THIS, THE CONSULTANT WOULD TURN OFF VENTILATION COMPLETELY, EFFECTIVELY MAKING THE PATIENT APNEIC. SHE WOULD TURN IT BACK ON AFTER A MINUTE AND CONTINUE FLUCTUATING ON BILATERAL AND ONE LUNG VENTILATION (AMBU COMMENT: THE SECOND ISSUE/COMPLAINT FOR THE REPORTED EVENT. A NON-DEFLATING LUNG IS MOST COMMONLY CAUSED BY MALPOSITION OF THE TUBE OR BY PATIENT RELATED FACTORS). · THE PROCEDURE HAD TO BE STOPPED, WITH THE DLT REMOVED AND A STANDARD ETT REPLACING IT. THEY THEN WANTED TO SEND THE PATIENT OFF FOR A SCAN, BEFORE DETERMINING IF THEY NEEDED TO DO AN OPEN CHEST PR

  Patient problems: Hypoxia

  MAUDE report 24453460 ↗
• MalfunctionJan 6, 2026Structural Problem

  THE DOCTOR POINTED OUT TO US THAT THE BENDING ANGLES AT THE DISTAL END OF UNUSED VISI 2 DLTS ARE DIFFERENT. WE COMPARED DIFFERENT LOT AND ITEM NUMBERS. ALL ITEMS HAVE BEEN DISCARDED BY THE HOSPITAL, NO SAMPLE AVAILABLE.THE DOCTOR HAS FURTHERMORE, INFORMED THAT DURING SEVERAL INTUBATIONS, THERE WERE DIFFICULTIES ADVANCING THE TUBE AFTER PASSING THE VOCAL CORDS. THE FIRST PHOTO SHOWS THE PACKAGING WITH THE LABEL OF ONE OF THE "PROBLEMATIC TUBES." THE OTHER TWO PHOTOS SHOW THE SIGNIFICANT DIFFERENCE IN THE BRONCHIAL CURVATURE COMPARED TO A CONVENTIONAL COMPETITOR PRODUCT (WITH WHICH THERE ARE INDEED NO PROBLEMS DURING PLACEMENT). COMMENT FROM AMBU: UNFORTUNATELY, NO PHOTOS OR EXACT INFORMATION ON ITEM NUMBERS AND LOT NUMBERS WERE PROVIDED BY THE DOCTOR. DESPITE SEVERAL FOLLOW-UP ATTEMPTS, WE HAVE NOT BEEN ABLE TO GET IN CONTACT WITH THE CUSTOMER. WE HAVE CREATED THE MDR REPORT ON VIVASIGTH DLT KIT SIZE 37. ON 3RD FEBRUARY 2026: ADDITIONAL INFORMATION WAS RECIEVED INCLUDING LOT NUMBERS AND PICTURES FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23978339 ↗
• MalfunctionJan 6, 2026Structural Problem

  THE DOCTOR POINTED OUT TO US THAT THE BENDING ANGLES AT THE DISTAL END OF UNUSED VISI 2 DLTS ARE DIFFERENT. WE COMPARED DIFFERENT LOT AND ITEM NUMBERS. ALL ITEMS HAVE BEEN DISCARDED BY THE HOSPITAL, NO SAMPLE AVAILABLE.THE DOCTOR HAS FURTHERMORE, INFORMED THAT DURING SEVERAL INTUBATIONS, THERE WERE DIFFICULTIES ADVANCING THE TUBE AFTER PASSING THE VOCAL CORDS. THE FIRST PHOTO SHOWS THE PACKAGING WITH THE LABEL OF ONE OF THE "PROBLEMATIC TUBES." THE OTHER TWO PHOTOS SHOW THE (SIGNIFICANT) DIFFERENCE IN THE BRONCHIAL CURVATURE COMPARED TO A CONVENTIONAL COMPETITOR PRODUCT (WITH WHICH THERE ARE INDEED NO PROBLEMS DURING PLACEMENT). COMMENT FROM AMBU: UNFORTUNATELY, NO PHOTOS OR EXACT INFORMATION ON ITEM NUMBERS AND LOT NUMBERS WERE PROVIDED BY THE DOCTOR. AMBU HAS DESPITE SEVERAL FOLLOW-UP ATTEMPTS NOT BEEN ABLE TO GET IN CONTACT WITH HIM. AMBU HAVE CREATED THE MDR REPORT ON VIVASIGTH DLT KIT SIZE 37.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971473 ↗
• MalfunctionAug 28, 2024Difficult to Insert; Structural Problem; Difficult to Insert; Structural Problem

  ACCORDING TO INFORMATION FROM THE CUSTOMER. A PATIENT NEEDED TO BE URGENTLY INTUBATED WITH A DLT SIZE 37. DURING THE FIRST ATTEMPT, MC GRATH WAS USED, PROVIDING A GOOD OVERVIEW, BUT IT WAS IMPOSSIBLE TO PLACE THE DLT DUE TO A HYPERANGULATED TIP. IT HAS BEEN ATTEMPTED BEFOREHAND, DURING PREPARATION, TO MANUALLY STRAIGHTEN THE TIP. DURING THE SECOND ATTEMPT, A NEW DLT SIZE 37 WAS USED, BUT THE SAME PROBLEM OCCURED. THE INTUBATOR WAS CHANGED, AND THE ANESTHESIOLOGIST FORCED THE DLT THROUGH THE VOCAL CORDS AND TRACHEA WITH GREAT DIFFICULTY AND HARD PRESSURE. NO FURTHER IMPACT TO PATIENT OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088934 ↗
• MalfunctionAug 28, 2024Difficult to Insert; Structural Problem; Difficult to Insert; Structural Problem

  ACCORDING TO INFORMATION FROM THE CUSTOMER. A PATIENT NEEDED TO BE URGENTLY INTUBATED WITH A DLT SIZE 37. DURING THE FIRST ATTEMPT, MC GRATH WAS USED, PROVIDING A GOOD OVERVIEW, BUT IT WAS IMPOSSIBLE TO PLACE THE DLT DUE TO A HYPERANGULATED TIP. IT HAS BEEN ATTEMPTED BEFOREHAND, DURING PREPARATION, TO MANUALLY STRAIGHTEN THE TIP. DURING THE SECOND ATTEMPT, A NEW DLT SIZE 37 WAS USED, BUT THE SAME PROBLEM OCCURED. THE INTUBATOR WAS CHANGED, AND THE ANESTHESIOLOGIST FORCED THE DLT THROUGH THE VOCAL CORDS AND TRACHEA WITH GREAT DIFFICULTY AND HARD PRESSURE. NO FURTHER IMPACT TO PATIENT OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085633 ↗
• MalfunctionMay 7, 2022Inflation Problem; Inflation Problem

  DURING THE PROCEDURE WITH VIVASIGHT 2 DLT THE CUFF MALFUNCTIONS WERE IDENTIFIED SHORTLY AFTER INTUBATION AND PRIOR TO INITIATION OF THE SURGICAL PROCEDURE. THE TUBE WAS REPLACED WITH A SECOND TUBE. THE PATIENT HAD TO BE RE-INTUBATED WITH A THIRD TUBE TO GAIN CONTROL THE AIRWAY DURING THE PROCEDURE. IT WAS CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT AND NO IMPACT ON PATIENT OUTCOME. TWO REPLACEMENTS AND A TOTAL OF THREE DLT TUBES ARE REQUIRED TO GAIN CONTROL OF THE AIRWAY DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319614 ↗
• InjuryMay 7, 2022Therapeutic or Diagnostic Output Failure

  DURING THE PROCEDURE WITH VIVASIGHT 2 DLT THE CUFF MALFUNCTIONS WERE IDENTIFIED SHORTLY AFTER INTUBATION AND PRIOR TO INITIATION OF THE SURGICAL PROCEDURE. THE TUBE WAS REPLACED WITH A SECOND TUBE. THE PATIENT HAD TO BE RE-INTUBATED WITH A THIRD TUBE TO GAIN CONTROL THE AIRWAY DURING THE PROCEDURE. IT WAS CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT AND NO IMPACT ON PATIENT OUTCOME. TWO REPLACEMENTS AND A TOTAL OF THREE DLT TUBES ARE REQUIRED TO GAIN CONTROL OF THE AIRWAY DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319551 ↗
• InjuryMar 11, 2022Break

  DURING PROCEDURE WITH VIVASIGHT 2 DLT THE TRACHEAL CUFF BROKE INSIDE THE PATIENT. THE TUBE WAS REPLACED WITH A SECOND TUBE. AFTER AROUND ONE HOUR THE PATIENT HAD TO BE RE-INTUBATED WITH A THIRD TUBE TO GAIN CONTROL OF THE AIRWAY DURING THE PROCEDURE. IT WAS CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT AND NO IMPACT ON PATIENT OUTCOME. TWO REPLACEMENTS AND A TOTAL OF THREE DLT TUBES ARE REQUIRED TO GAIN CONTROL OF THE AIRWAY DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13737567 ↗
• MalfunctionMar 10, 2022Inflation Problem; Inflation Problem

  DURING PROCEDURE WITH VIVASIGHT 2 DLT THE TRACHEAL CUFF BROKE INSIDE THE PATIENT. THE TUBE WAS REPLACED WITH A SECOND TUBE. AFTER AROUND ONE HOUR THE PATIENT HAD TO BE RE-INTUBATED WITH A THIRD TUBE TO GAIN CONTROL THE AIRWAY DURING THE PROCEDURE. IT WAS CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT AND NO IMPACT ON PATIENT OUTCOME. TWO REPLACEMENTS AND A TOTAL OF THREE DLT TUBES ARE REQUIRED TO GAIN CONTROL OF THE AIRWAY DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13722690 ↗