MUSTANG™ H74939171051570Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729794042), received between Jun 21, 2019 and Nov 25, 2025 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 5.0 X 150, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 24 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650661 ↗
• InjuryJan 12, 2024Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BALLOON HAD RUPTURED AND A PORTION WAS NOT POSSIBLE TO REMOVE, REQUIRING SURGICAL INTERVENTION. A 5.0 X 150, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE IN THE RIGHT BRACHIAL ARTERY. UNDER LOCAL ANESTHESIA, A 6 FRENCH SHEATH WAS INSERTED, FOLLOWED BY ADVANCEMENT OF A TEFION-COATED GUIDE WIRE INTO THE PROXIMAL COURSE OF THE RADIAL ARTERY AND INSERTION OF A GUIDE CATHETER. THE MUSTANG BALLOON CATHETER WAS ADVANCED AND INITIALLY UNCOMPLICATED PTA OF THE BASILIC VEIN AND THE DISTAL THIRD OF THE UPPER ARM WERE PERFORMED, FOLLOWED BY WITHDRAWAL OF THE BALLOON CATHETER AND OVERLAPPING PTA OF THE ARTERIOVENOUS ANASTOMOSIS AND THE ENTIRE COURSE OF THE RADIAL ARTERY. THE PTA WAS CARRIED OUT WITHOUT COMPLICATIONS, EACH WITH PRESSURES OF APPROXIMATELY 20 ATMOSPHERES. HOWEVER, TOWARD THE END OF THE PTA OF THE RADIAL BRANCH, THE PATIENT HAD SUDDENLY EXPERIENCED SHORT-TERM PAIN. FLUOROSCOPY SHOWED A RUPTURE OF THE MUSTANG BALLOON. AFTER THE BALLOON HAD LARGELY EMPTIED, IT WAS CAREFULLY PULLED BACK APPROXIMATELY 3 CENTIMETERS UNTIL IT CAME TO A COMPLETE STOP. UPON FURTHER OBSERVATION, IT WAS DISCOVERED THAT THE BAL

  Patient problems: Pain

  MAUDE report 18504200 ↗
• MalfunctionJun 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MODERATELY TORTUOUS VESSEL. A 5.0 X 150, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED VERTICALLY. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133483 ↗
• MalfunctionMay 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL LEFT FOREARM. A 5.0 X 150, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING 7TH INFLATION AT 24 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983317 ↗
• MalfunctionMar 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150MM, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE THIRD INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789372 ↗
• MalfunctionJun 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8725346 ↗