MUSTANG™ H74939171040670Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729794349), received between Mar 16, 2023 and Feb 3, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0 X 60, 75CM MUSTANG WAS USED FOR DILATION. DURING PROCEDURE, BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES INSIDE A PATIENTS BILE DUCT. THE PHYSICIAN OBSERVED NO RESISTANCE DURING BALLOON INFLATION AND NOTED THE PRESENCE OF BILE, SUGGESTING THAT THE BALLOON HAD RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293563 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 4.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE MIDDLE OF THE BALLOON CATHETER SHAFT BROKE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925184 ↗
• MalfunctionNov 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 4.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST UPON SECOND INFLATION AT 18 ATMOSPHERES FOR 4 SECONDS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20753647 ↗
• MalfunctionNov 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTIFICIAL ARTERIOVENOUS FISTULA. A 4.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT 90% STENOSED TARGET LESION WAS LOCATED IN THE OVER MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES. THE DEVICE WAS NORMALLY REMOVED VIA THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750665 ↗
• MalfunctionOct 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTIFICIAL ARTERIOVENOUS FISTULA STENOSIS. A 4.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20455139 ↗
• MalfunctionJun 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 4.0 X 60, 75CM MUSTANG CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INFLATION. THE PROCEDURE WAS COMPLETED WITH A SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521713 ↗
• MalfunctionMar 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT RADIAL VEIN. A 4.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. IN PREPARATION FOR PROCEDURE, THE BALLOON WAS UNPACKED AND FLUSHED. HOWEVER, IT WAS FOUND THAT THE BALLOON WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555353 ↗