MUSTANG™ H74939171041570Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729794462), received between Jan 21, 2025 and Dec 25, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inflation 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.
Reports received per month
Most reported problems
Device problems
- Inflation Problem1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 25, 2025Inflation Problem; Inflation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10DEC2025. IT WAS REPORTED THAT BALLON FAILURE TO INFLATE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ARTERIOVENOUS FISTULA. A 4.0 X 150, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON FAILED TO FULLY INFLATE TO 4 MM DUE TO SIGNIFICANT VESSEL STENOSIS. THE PHYSICIAN THEN OPTED TO USE AN ATHLETIS HIGH-PRESSURE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23892284 ↗MalfunctionJan 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 150, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21196674 ↗
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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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