MUSTANG™ H74939171120210Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729794356), received between Oct 15, 2020 and Feb 15, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• MalfunctionFeb 15, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS PULMONARY ARTERY. A 12.0 X 20 MM, 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. UPON INITIATION OF BALLOON INFLATION AT THE LESION SITE, THE BALLOON CEASED INFLATING AT APPROXIMATELY NOMINAL PRESSURE. FOLLOWING DEFLATION, THE DEVICE WAS REMOVED FROM THE PATIENT. VISUAL INSPECTION REVEALED A SMALL HOLE IN THE BALLOON, AND WHEN THE BALLOON WAS REINFLATED WITH SALINE, LEAKAGE WAS OBSERVED FROM THE IDENTIFIED DEFECT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341707 ↗
• MalfunctionAug 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILD CALCIFIED VESSEL. A 12.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829857 ↗
• MalfunctionMar 22, 2021Material Rupture; Material Rupture

  WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. A 12.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY ISSUE AND A PINHOLE WAS NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION. IT WAS FURTHER REPORTED THAT THE BALLOON WAS EXPANDED OUTSIDE THE BODY DURING PREPARATION TO CHECK FOR DEFECTS. PRESSURE WAS NOT APPLIED AND THE PRESSURE WAS DECREASED. THE DEVICE WAS THEN USED AND INFLATED IN THE TARGET LESION WHICH WAS AN AREA IN-STENT RESTENOSIS OF A NON-BSC STENT WHERE THE BALLOON RUPTURED DURING INITIAL INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11544002 ↗
• MalfunctionOct 19, 2020Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE COMMON BILE DUCT ARTERY. A 12.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. WHEN THE PHYSICIAN INJECTED CONTRAST AGENT IN PUMP, THE BALLOON COULD NOT BE FULLY INFLATED. THE DEVICE WAS WITHDRAWN AND FLUSHED OUTSIDE THE PATIENT'S BODY; HOWEVER, A LEAK WAS FOUND AND A VISIBLE PINHOLE WAS NOTED ON THE BALLOON MATERIAL. 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 10695560 ↗
• MalfunctionOct 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON TEAR OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON BILE DUCT. A 12.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, WHEN PRESSURE PUMP WAS INJECTED WITH CONTRAST AGENT, THE BALLOON DID NOT FULLY INFLATE. WHEN THE DEVICE WAS REMOVED AND FLUSHED OUTSIDE THE PATIENT'S BODY, A BALLOON TEAR WAS NOTED. 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 10682833 ↗