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MUSTANG™ H74939171070240Recalls & 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 08714729794370), received between Mar 22, 2019 and Mar 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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

  • Material Rupture1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMar 22, 2019Material Rupture; Material Rupture

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED BASILIC VEIN. A 7.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY NOR COMPLICATIONS WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8445335 ↗

Other CATHETER, BILIARY, DIAGNOSTIC devices

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Sources and updates

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