EXALT™ M0054276Z0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506007843), received between Jul 12, 2023 and Jan 31, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025Overheating of Device; Power Problem; Overheating of Device; Power Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR'S POWER CABLE STOPPED WORKING ON (B)(6) 2025. THE POWER CABLE WAS OVERHEATING AND NOT PROVIDING CHARGE TO THE MONITOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281984 ↗
• MalfunctionJul 12, 2023Adverse Event Without Identified Device or Use Problem; Optical Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2023-03794 FOR THE EXALT MODEL B SCOPE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR KIT WAS USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT DURING THE PROCEDURE THE IMAGE OF THE EXALT MODEL B SCOPE FLICKERED AND THEN IT WAS LOST. THE IMAGE WAS ABLE TO BE REGAINED AFTER UNPLUGGING AND RE-PLUGGING THE SCOPE INTO THE EXALT MODEL B MONITOR. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME EXALT B SCOPE AND MONITOR. THERE WERE NO 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 17305864 ↗
• MalfunctionJul 12, 2023Adverse Event Without Identified Device or Use Problem; Optical Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2023-03794 FOR THE EXALT MODEL B SCOPE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL B MONITOR KIT WAS USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT DURING THE PROCEDURE THE IMAGE OF THE EXALT MODEL B SCOPE FLICKERED AND THEN IT WAS LOST. THE IMAGE WAS ABLE TO BE REGAINED AFTER UNPLUGGING AND RE-PLUGGING THE SCOPE INTO THE EXALT MODEL B MONITOR. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME EXALT B SCOPE AND MONITOR. THERE WERE NO 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 17305856 ↗