MUSTANG™ H74939171070810Recalls & 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
- 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 08714729794288), received between Mar 5, 2019 and Oct 29, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture2
- Adverse Event Without Identified Device or Use Problem1
- Failure to Deflate1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2025Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Adverse Event Without Identified Device or Use Problem; Failure to Deflate
IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. A 7.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY. DURING THE PROCEDURE, BALLOON WAS INSERTED AND INFLATED. UPON DEFLATION WITH INFLATOR, IT WOULD NOT BE DEFLATED. A SYRINGE WAS USED TO PULL NEGATIVE TO GET IT TO DEFLATE IN ORDER TO REMOVE IT THROUGH THE SHEATH FROM BODY. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413667 ↗MalfunctionFeb 12, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING RATED BURST PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11325668 ↗MalfunctionMar 5, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED BEFORE REACHING RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8390694 ↗
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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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