SpyGlass™ Discover M00543000Recalls & reported problems
Boston Scientific Corporation · Balloon Dilation Catheter · Class 2
All models of SpyGlass Discover (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506013516), received between May 28, 2026 and May 28, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER BALLOON WAS USED DURING A PROCEDURE PERFORMED IN THE COMMON BILE DUCT (CBD) ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN USED A DISCOVER BALLOON TO ACCESS AND VISUALIZE THE CBD. THE PATIENT WAS FOUND TO HAVE A STRICTURE AND SUBSEQUENTLY REQUIRED STENT PLACEMENT. THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER HOSPITAL FOR STENT PLACEMENT. IT WAS REPORTED THAT THE PATIENT HAD A STRICTURE AND REQUIRED HOSPITAL ADMISSION BEYOND THE STANDARD OF CARE BUT WAS SUBSEQUENTLY DISCHARGED.
Patient problems: Stenosis
MAUDE report 25319697 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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