MUSTANG™ H74939171031510Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729794516), received between Nov 27, 2019 and Jul 14, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0 X 150, 135CM MUSTANG? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER 3 X 150 MM MUSTANG BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496534 ↗
• MalfunctionFeb 4, 2025Inflation Problem; Leak/Splash; Material Integrity Problem; Inflation Problem; Leak/Splash; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15JAN2025. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT FEMORAL ARTERY. A 3.0 X 150, 135CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE PATIENT WAS IN THE SUPINE POSITION, AND THE PHYSICIAN PUNCTURED THE LESION WITH 8F, AND SUCCESSFULLY PLACED THE SHEATH AND GUIDING CATHETER. WHEN THE BALLOON REACHED THE LESION SITE, THE PRESSURE PUMP WAS PRESSURIZED AT 4 ATMOSPHERES. HOWEVER, IT WAS NOTED THAT THE BALLOON COULD NOT BE INFLATED, SHOWING THAT THERE WAS EXTRAVASATION OF CONTRAST MEDIUM. WHEN THE BALLOON WAS WITHDRAWN, IT WAS FOUND THAT THE MIDDLE END OF THE BALLOON WAS DAMAGED, AND THEN IT WAS WITHDRAWN FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE LOCATED APPROXIMATELY 22MM PROXIMAL OF THE DISTAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307479 ↗
• MalfunctionJan 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 3.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED DURING GRADUAL PRESSURIZATION OF THE PRESSURE PUMP. THE DEVICE WAS REMOVED WITHOUT ANY ISSUES, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201307 ↗
• MalfunctionAug 15, 2024Inflation Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31JUL2024. IT WAS REPORTED THAT TIP LEAKAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 3.0 X 150, 135CM MUSTANG BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE BALLOON WAS PRESSURIZED, THE BALLOON DID NOT CHANGE. THE CONTRAST AGENT OVERFLOWED, SO THE BALLOON WAS WITHDRAWN, AND WATER WAS INJECTED WITH A SYRINGE. IT WAS THEN NOTED THAT THE TIP WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE LOCATED AT THE DISTAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19989500 ↗
• MalfunctionJan 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL BELOW THE KNEE. A 3.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9622486 ↗
• MalfunctionNov 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH LEG SWELLING AND CLAUDICATION WHICH LASTED FOR 15 DAYS. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED FEMORAL ARTERY. A 3.0X150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 20 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9387748 ↗