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MUSTANG™ H74939171081270Recalls & 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 08714729794431), received between Sep 18, 2019 and Sep 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Material Rupture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 18, 2019Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

    IT WAS REPORTED THAT BALLOON RUPTURE AND DETACHMENT OCCURRED. A 8.0 X 120, 75CM MUSTANG BALLOON CATHETER WAS USED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED AND SHREDDED APART IN THE PATIENT'S BODY. THE DETACHED FRAGMENT WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9083911 ↗

Other CATHETER, BILIARY, DIAGNOSTIC devices

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Sources and updates

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