MUSTANG™ H74939171061270Recalls & 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 08714729794127), received between Oct 7, 2022 and Sep 19, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash2
- 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.
MalfunctionSep 19, 2024Leak/Splash; Leak/Splash
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10SEP2024. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 6.0 X 120, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INDEFLATION, CONTRAST LEAKING WAS CONFIRMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FINE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20261682 ↗MalfunctionOct 7, 2022Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 35% STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED BRACHIOCEPHALIC ARTERY. A 6.0 X 120, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS ATTEMPTED TO BE INFLATED TWICE AT 4-6 ATMOSPHERES, HOWEVER, THE BALLOON COULD NOT BE INFLATED TO NOMINAL PRESSURE. THE DEVICE WAS REMOVED FROM THE PATIENT AND UPON CHECKING, THERE WAS A SMALL HOLE AT THE TIP OF THE BALLOON. THE PHYSICIAN USED AN INFLATION DEVICE TO INFLATE THE BALLOON AT 4 ATMOSPHERES AND NOTICED THAT THERE IS A SMALL LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER 6.0MM X 80MM 75CM MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15566511 ↗
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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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