MUSTANG™ H74939171070210Recalls & reported problems
Boston Scientific Corporation · PTA Balloon Dilatation Catheter · Class 2
All models of MUSTANG (131)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729793830), received between Apr 22, 2024 and Apr 22, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2024Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 7.0 X 20, 135CM MUSTANG BALLOON WAS SELECTED TO BE USED IN AN ANGIOPLASTY PROCEDURE OF THE MESENTERIC ARTERY. THE MUSTANG BALLOON WAS ADVANCED FOR DILATION; HOWEVER, IT HAD DIFFICULTY ADVANCING INTO THE 7 FRENCH GUIDE CATHETER. IT WAS THEN ATTEMPTED TO ADVANCE THE STENT, AND THE EXPRESS LD VASCULAR NEVER PASSED THE TIP OF THE CATHETER. AS A RESULT, THE DILATION TREATMENT COULD NOT BE PERFORMED, AND THE PROCEDURE WAS POSTPONED FOR A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19158214 ↗
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- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
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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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