MUSTANG™ H74939171040240Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729794172), received between Dec 17, 2018 and May 27, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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.

• MalfunctionMay 27, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL IN THE FOREARM. A 4.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300409 ↗
• MalfunctionOct 1, 2021Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL CUTANEOUS VEIN. A 4.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, A PINHOLE-LIKE RUPTURE IN THE BALLOON OR SHAFT OCCURRED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 75% STENOSED. THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, AND THERE WAS A PINHOLE NOTED ON THE SHAFT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12560088 ↗
• MalfunctionJul 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT FOREARM VESSEL. A 4.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED DURING INFLATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171710 ↗
• MalfunctionAug 26, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS VESSEL. A 4.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. AFTER INFLATION WAS PERFORMED, THE GUIDE WIRE REMAINED AND ANGIOGRAPHY WAS TRIED TO PERFORM. HOWEVER, THE BALLOON CATHETER COULD NOT BE REMOVED FROM THE GUIDE WIRE. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8931995 ↗
• MalfunctionDec 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 4.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INITIAL INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 5-20/5.3/40 MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171707 ↗