MUSTANG™ H74939171072010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729793748), received between Jul 27, 2023 and Sep 11, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Break; Material Rupture; Adverse Event Without Identified Device or Use Problem; Break; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC VEIN. A MUSTANG 7.0 X 200, 135CM WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY. DURING THE FIRST INFLATION AT BELOW NOMINAL PRESSURE FOR FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031139 ↗
• MalfunctionNov 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST BEFORE REACHING THE NOMINAL PRESSURE. THE BALLOON WAS REMOVED SUCCESSFULLY, AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692026 ↗
• InjuryJul 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED SUBCLAVIAN VEIN AND ARTERIOVENOUS FISTULA CIRCUIT. A 7.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT RATED BURST PRESSURE FOR A FEW SECONDS, THE BALLOON RUPTURED AND FRAGMENTED LEAVING PIECES IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FRAGMENTS BUT WAS UNSUCCESSFUL AND CONSEQUENTLY HAD TO PLACE A COVERED STENT IN THE PATIENT TO TRAP THE BALLOON FRAGMENTS AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17410118 ↗