MUSTANG™ H74939171060640Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729794783), received between Dec 3, 2019 and Sep 21, 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.

• MalfunctionSep 21, 2026Material Rupture

  It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and non-calcified cephalic vein. A 6.0 x 60, 40cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at 10 atmospheres. 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 50836560 ↗
• MalfunctionFeb 3, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS SLOW TO DEFLATE. THE PATIENT PRESENTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 6.0 X 60, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING WITHDRAWAL, IT WAS NOTED THAT THE BALLOON WAS SLOW TO DEFLATE. THE DEVICE WAS REMOVED INTACT AND IN A DEFLATED STATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294643 ↗
• MalfunctionMay 19, 2021Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-APR-2021. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. AFTER A GUIDEWIRE WAS CROSSED THE LESION, A 6.0 X 60, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION BUT THE BALLOON COULD NOT INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852577 ↗
• MalfunctionOct 29, 2020Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE KIDNEY. A 6.0 X 60MM, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE PHYSICIAN USED A PRESSURE PUMP, THE BALLOON COULD NOT BE INFLATED. THE BALLOON WAS LEAKING WITH SALINE/CONTRAST AND HAD A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10758962 ↗
• MalfunctionDec 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS IN AN ARTERIOVENOUS FISTULA. A 6.0 X 60, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9407299 ↗