MUSTANG™ H74939171051210Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729793410), received between Jul 29, 2020 and Aug 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD LOSS OR HEMORRHAGE. A 5.0 X 120, 135CM MUSTANG WAS SELECTED FOR VASCULAR CASE IN THE RIGHT BRACHIAL ARTERY. DURING THE PROCEDURE, THE BALLOON CATHETER WAS INTRODUCED THROUGH A NON-BSC INTRODUCER SHEATH. WHILE INSERTION WAS SUCCESSFUL, REMOVAL OF THE BALLOON AFTER IT WAS USED WAS DIFFICULT. IT REQUIRED SIGNIFICANT FORCE, AND WHICH RESULTED IN STRETCHING OF THE SHEATH AND THEN THE BALLOON SNAPPED INSIDE THE SHEATHS HUB. THE SHEATH HAD TO BE REMOVED, AND MANUAL PRESSURE WAS APPLIED TO THE BRACHIAL ARTERY FOR REMAINDER OF CASE TO COMPLETE THE PROCEDURE FEMORALLY. CONSEQUENTLY, THE PATIENT EXPERIENCED BLOOD LOSS OR HEMORRHAGE DUE TO THIS EVENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20045018 ↗
• MalfunctionAug 26, 2020Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05AUG2020. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 120, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, AFTER DILATATION, ANGIOGRAPHY IMAGE SHOWED LEAKING OF CONTRAST AGENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457045 ↗
• MalfunctionJul 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN UNOBSTRUCTED AND NON-TORTUOUS LEFT COMMON ILIAC ARTERY. A 5.0 X 120, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION, THERE WAS LEAKAGE OF DYE NOTED FROM THE BALLOON AND THE BALLOON COULD NOT INCREASE PRESSURE. A VERY SMALL HOLE WAS NOTED AT THE EDGE OF THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10341083 ↗