MUSTANG™ H74939171081510Recalls & 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 08714729794110), received between Jun 22, 2026 and Jun 22, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Deflate” (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
- Failure to Deflate1
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.
MalfunctionJun 22, 2026Failure to Deflate
IT WAS REPORTED THAT A DEFLATION FAILURE OCCURRED. A MUSTANG 8.0 X 150 MM BALLOON CATHETER WAS SELECTED FOR USE DURING A VENOGRAPHY OF THE LOWER EXTREMITY, ILIAC VEIN BALLOON DILATATION, AND STENT IMPLANTATION PROCEDURE FOR TREATMENT OF LOWER EXTREMITY ILIAC VEIN STENOSIS. THE BALLOON WAS ADVANCED THROUGH A 6F SHEATH AND INFLATED WITHIN THE VESSEL. AFTER INFLATION, THE BALLOON COULD NOT BE FULLY RETRACTED. NEGATIVE PRESSURE WAS APPLIED, AND THE BALLOON WAS SUCCESSFULLY WITHDRAWN FROM THE PATIENT TOGETHER WITH THE SHEATH. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25587859 ↗
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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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