EXALT™ Model B M00542710Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506007423), received between Feb 25, 2022 and Jul 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (1 report).

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.

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.

• MalfunctionJul 13, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B SINGLE USE BRONCHOSCOPE, SLIM, WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON JULY 5, 2023, INDICATED THAT THE EXALT B SCOPE'S IMAGE FLICKERED AND SUBSEQUENTLY BECAME LOST WHILE THE SCOPE WAS INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315343 ↗
• MalfunctionFeb 25, 2022Suction Problem; Suction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B SINGLE-USE BRONCHOSCOPE, SLIM WAS USED DURING A BRONCHO-ALVEOLAR LAVAGE PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SUCTION BUTTON OF THE EXALT MODEL B SINGLE-USE BRONCHOSCOPE BECAME STUCK IN THE DEPRESSED POSITION CAUSING MINOR BLEEDING TO THE BRONCHIAL MUCOSA AND TRACHEA. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE BLEEDING REQUIRED NO ADDITIONAL TREATMENT AND THE PATIENT HAS RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13602378 ↗