MUSTANG™ H74939171031010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729794295), received between Apr 7, 2023 and May 8, 2025 — classified as 4 malfunctions.

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

• MalfunctionMay 8, 2025Entrapment of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 3.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BECAME STUCK ON THE JAGWIRE AND WAS VERY DIFFICULT TO MOVE OR USE. THE BALLOON WAS PULLED VERY HARD, RESULTING TO BALLOON DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989989 ↗
• MalfunctionDec 12, 2024Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02DEC2024. IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS GRAFT (AVG). A 3.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 23 ATMOSPHERES, THE BALLOON DID NOT FULLY EXPAND. THE DEVICE WAS REPLACED WITH AN ATHLETIS HIGH-PRESSURE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916483 ↗
• MalfunctionOct 21, 2024Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT THE BALLOON COULD NOT DILATE. THE STENOSED TARGET LESION WAS LOCATED IN THE OCCLUDED SUPERFICIAL FEMORAL ARTERY. THE GUIDEWIRE WAS CROSSED SMOOTHLY, AND A 3.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. AFTER REACHING THE LESION, THE PRESSURE PUMP WAS USED, BUT THE BALLOON COULD NOT BE DILATED. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME BALLOON, AND THE PROCEDURE WAS CARRIED OUT NORMALLY. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490409 ↗
• MalfunctionApr 7, 2023Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT BALLOON INFLATION ISSUE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED FEMORAL ARTERY. A 3.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON FAILED TO INFLATE. THE BALLOON NEVER HELD PRESSURE AND NO VISIBLE PINHOLE WAS IDENTIFIED THAT COULD CONTRIBUTE TO THE INFLATION FAILURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701408 ↗