MUSTANG™ H74939171081010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729794233), received between Jun 17, 2020 and Jul 20, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC ARTERY. AN 8.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED IMMEDIATELY AT THE NOMINAL PRESSURE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25872455 ↗
• MalfunctionMay 22, 2024Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50-60 % STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. AN 8.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 3 ATMOSPHERES, THE BALLOON BURST AND LEAK, AND COULD NOT INFLATE. THE DEVICE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376376 ↗
• MalfunctionMar 14, 2024Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LIMB. AN 8.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING PREPARATION, THE PRESSURE OF THE BALLOON TIP WAS NOT ENOUGH, AND IT WAS LEAKING WATER. A VISIBLE PINHOLE WAS NOTED ON THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908984 ↗
• MalfunctionNov 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN RIGHT POPLITEAL ARTERY. AN 8.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT APPROXIMATELY 18 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10825720 ↗
• MalfunctionJun 17, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT BRACHIAL ARTERY. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ILIOFEMORAL ARTERY. AFTER A 6F PUNCTURE SHEATH AND A 6F NON-BSC LONG SHEATH WAS PLACED, AN 8.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, FOLLOWING DEFLATION, THE BALLOON COULD NOT BE RETRIEVED EVEN AFTER SEVERAL ATTEMPTS. SUBSEQUENTLY, THE BALLOON WAS FORCED BACK TO THE SHEATH AND RETRIEVED BOTH DEVICES. AN 8X80 INNOVA STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164227 ↗