MUSTANG™ H74939171050610Recalls & 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 08714729793878), received between Apr 11, 2025 and Jun 1, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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 Insert1
- Entrapment of Device1
- Fluid/Blood Leak1
- 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.
MalfunctionJun 1, 2026Fluid/Blood Leak; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 5.0 X 60, 135CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 16-18 ATMOSPHERES FOR THE FIRST 10 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED SUCCESSFULLY FROM THE PATIENT WITHOUT ANY DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354115 ↗MalfunctionApr 11, 2025Entrapment of Device; Difficult to Insert; Entrapment of Device; Difficult to Insert
IT WAS REPORTED THAT FROZE ON WIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 5.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS USED FOR DILATION. PRIOR TO THE PROCEDURE, AN ATTEMPT TO INSERT THE BALLOON CATHETER INTO THE PATIENT WAS UNSUCCESSFUL AND THE BALLOON AND GUIDEWIRE BECAME STUCK TOGETHER, RESULTING IN BOTH BEING WITHDRAWN SIMULTANEOUSLY. THIS SAME ISSUE OCCURRED WITH A SECOND BALLOON CATHETER. THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY USING ANOTHER DEVICE OF THE SAME TYPE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21830426 ↗
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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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