Emerge™ H7493918908250Recalls & reported problems
Boston Scientific Corporation · PTCA Dilatation Catheter · Class 2
All models of Emerge (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729806523), received between Nov 30, 2021 and Mar 4, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 8MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND THAT THE SHAFT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507310 ↗MalfunctionDec 14, 2021Leak/Splash; Leak/Splash
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07DEC2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. A 2.50MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION THE DEVICE FAILED TO INFLATE. WHEN THE DEVICE WAS REMOVED AND INFLATED, A LEAKED WAS NOTICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12994057 ↗MalfunctionNov 30, 2021Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 2.50MM X 8MM EMERGE BALLOON CATHETER WAS INSERTED INTO THE GUIDE CATHETER. HOWEVER, DURING INTRODUCTION, THE BALLOON SHAFT FRACTURED AT ABOUT 6IN FROM THE HUB. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12898686 ↗
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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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