MUSTANG™ H74939171050440Recalls & reported problems

Summary

The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 08714729793731), received between Apr 6, 2017 and Sep 21, 2026 — classified as 1 injury, 168 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (158 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 25 most recent of 169 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Rupture

  It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified veins in the left forearm. A 5.0 x 40, 40cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at nominal pressure atmospheres for 30 seconds. The device was removed without any problem using the normal method, and the procedure was completed with another of same 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 50838899 ↗
• MalfunctionSep 4, 2026Material Rupture

  It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the non-tortuous and non-calcified shunt part. A 5.0 x 40, 40cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation. The device was removed without any problem, 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 50602133 ↗
• MalfunctionJun 29, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS ARTERIOVENOUS FISTULA. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME 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 25652799 ↗
• MalfunctionMay 18, 2026Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED BRACHIAL VEIN. A 5.0 X 40, 40CM MUSTANG BALLOON WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER BECAME STUCK WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. AS A RESULT, THE CATHETER AND GUIDEWIRE HAD TO BE REMOVED AS ONE UNIT. THE GUIDEWIRE WAS ABLE TO BE REMOVED FROM THE CATHETER OUTSIDE THE PATIENT, AND NO DEVICE DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25205187 ↗
• MalfunctionApr 27, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 6 ATMOSPHERES. 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 24995146 ↗
• MalfunctionApr 13, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SHUNT OF VENOUS SIDE. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED FROM A PINHOLE. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 24858757 ↗
• MalfunctionApr 9, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X 40, 40 CM MUSANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 24825680 ↗
• MalfunctionMar 23, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. 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 24661388 ↗
• MalfunctionJan 8, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 24003461 ↗
• MalfunctionNov 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION, EXHIBITING 90% STENOSIS, WAS LOCATED IN THE MODERATELY TORTUOUS, NON-CALCIFIED LEFT FOREARM SHUNT VEIN. A 5.0 X 40 MM, 40 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566037 ↗
• MalfunctionNov 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X 40,40CMMUSTANG BALLOON CATHETER WAS ADVANCE FOR DILATATION. DURING THE PROCEDURE, AT 8 ATMOSPHERES THE BALLOON RUPTURED. 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 23482674 ↗
• MalfunctionSep 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON PINHOLE WAS NOTED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED BRACHIAL ARTERY. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON COULD NOT INFLATE BY APPLYING PRESSURE WITH THE PRESSURE PUMP. UPON CHECKING, A PINHOLE WAS NOTED ON THE BALLOON. 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 23036548 ↗
• MalfunctionSep 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SHUNT ANASTOMOSIS. A 5.0 X 40, 40CM MUSTANG WAS SELECTED FOR USE IN A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE UPON FIRST INFLATION AT NOMINAL PRESSURE FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031132 ↗
• MalfunctionSep 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILD CALCIFIED V-SHUNT. A MUSTANG 5.0 X 40, 40CM WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURE IN A VERTICAL FORM. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983106 ↗
• MalfunctionAug 29, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE IN A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). UPON UNPACKING, IT WAS NOTED THAT THE DISTAL TIP HAS BEEN CUT DIAGONALLY. 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 22922086 ↗
• MalfunctionJun 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED CEPHALIC VEIN. A 5.0 X 40, 40CM 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 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 22176312 ↗
• MalfunctionJun 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE LEFT FOREARM. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON THIRD INFLATION AT 24 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161731 ↗
• MalfunctionMay 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE LEFT FOREARM. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCE FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON THIRD INFLATION AT 24 ATMOSPHERES FOR 1 MINUTE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061905 ↗
• MalfunctionMay 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL OF THE LEFT FOREARM. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCE FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED JUST BEFORE THE FIFTH INFLATION AT 24 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963825 ↗
• MalfunctionApr 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916827 ↗
• MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS SELECTED FOR TRANSARTERIAL VASCULAR ACCESS INTERVENTIONAL THERAPY (VAIVT). UPON UNPACKING AND TAKING OUT THE DEVICE, THE TIP APPEARED TO BE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF A DIFFERENT LOT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21598993 ↗
• MalfunctionFeb 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AMD MODERATELY CALCIFIED SHUNT VESSEL. A 5.0 X 40, 40 CM MUSTANG BALLOON CATHETER WAS ADVANCE FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 18 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337642 ↗
• MalfunctionJan 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE FOREARM. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144780 ↗
• MalfunctionJan 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21127767 ↗
• MalfunctionJan 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SHUNT STENOSIS PART. A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123788 ↗