MUSTANG™ H74939171030810Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729794936), received between Dec 10, 2020 and Sep 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2024Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29AUG2024. IT WAS REPORTED THE BALLOON DID NOT INFLATE. THE STENOSED AND OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 3.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION AND REACHED THE LESION. HOWEVER, UPON INFLATION. THE BALLOON COULD NOT BE INFLATED WITH A PRESSURE PUMP. NO VISIBLE PINHOLE NOTED ON THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED OF A BALLOON PINHOLE LOCATED APPROXIMATELY AT THE DISTAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279584 ↗
• MalfunctionDec 10, 2020Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A BALLOON PINHOLE WAS IDENTIFIED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 3.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE PHYSICIAN BEGAN TO INCREASE PRESSURE, THE BALLOON HAS NO NOTICED PRESSURE, AND THE PRESSURE WAS DECREASED EVERYTIME THE PHYSICIAN INCREASES THE PRESSURE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. UPON TRYING TO INFLATE THE BALLOON, IT WAS NOTICED THAT THE BALLOON HAVE SMALL PORE AT THE CONNECTION OF BALLOON AND SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10986030 ↗