MUSTANG™ H74939171090210Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729794165), received between Oct 18, 2018 and Apr 29, 2022 — classified as 2 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ARTERIAL STENOSIS. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 9.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FOURTH INFLATION AT 16 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254487 ↗
• MalfunctionOct 18, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 9.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, ON THE THIRD INFLATION AT 16 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7979292 ↗