MUSTANG™ H74939171040610Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729794257), received between Mar 25, 2019 and Apr 28, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 4.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT COULD NOT FULLY EXPAND WHEN PRESSURE WAS APPLIED. A VISIBLE PINHOLE WAS NOTED ON THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919034 ↗
• MalfunctionDec 25, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A 4.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED AND INFLATED THE SHUNT. HOWEVER, THE BALLOON COULD NOT BE FULLY OPENED WHEN DILATING THE STENOSIS. THE DEVICE WAS WITHDRAWN, AND A VISIBLE PINHOLE WAS NOTED ON THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21015257 ↗
• MalfunctionDec 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RADIAL VEIN. A 4.0 X 60, 135CM MUSTANG WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON BURST UPON INITIAL INFLATION AT 10 ATMOSPHERES FOR A FEW SECONDS. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18402115 ↗
• MalfunctionMar 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE STENOSED TARGET LESION WAS LOCATED IN THE POPLITEAL AND POSTERIOR TIBIAL ARTERY. A 4.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS PREPARED, FLUSHED WITH SALINE AND THEN ADVANCED INTO THE GUIDEWIRE INSIDE THE POPLITEAL. DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8449188 ↗