MUSTANG™ H74939171120470Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 08714729793441), received between Nov 6, 2018 and Sep 21, 2026 — classified as 4 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (76 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 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Rupture

  It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and mildly calcified subclavian vein. A 12.0 x 40, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon vertically ruptured from the tip to the middle upon first inflation at 8 atmospheres for 30 seconds. The device was removed only using normal method 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, and the patient was in good condition post-procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836564 ↗
• MalfunctionJul 27, 2026Fluid/Blood Leak; Inflation Problem; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045712 ↗
• MalfunctionJul 20, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25884328 ↗
• MalfunctionMay 1, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR CENTRAL VENOUS DILATION. DURING INFLATION AT 13 ATMOSPHERES, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059073 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11MAR2026. IT WAS REPORTED THAT BALLOON LEAKAGE AND INFLATION ISSUE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE BALLOON DILATATION, CONTRAST LEAKAGE WAS OBSERVED AT THE CATHETER TIP. AS A RESULT, THE BALLOON COULD NOT EXPAND PROPERLY AND WAS DEEMED DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A BREACH IN THE INFLATION LUMEN AND GUIDEWIRE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757300 ↗
• MalfunctionMar 23, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL COMMON ILIAC ARTERY. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 6 ATMOSPHERES (ATM). 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 24670512 ↗
• MalfunctionFeb 18, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED LEFT SUBCLAVIAN VEIN. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 5 SECONDS. 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 24377841 ↗
• MalfunctionJan 20, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUBCLAVIAN VEIN. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 5 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 24116528 ↗
• MalfunctionJan 13, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED AXILLARY VEIN. A 12.0 X 40, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 5 ATMOSPHERES FOR 1 MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED 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 24063779 ↗
• MalfunctionOct 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 12 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 23332091 ↗
• MalfunctionSep 3, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON DEFLATED SLOWLY. A MUSTANG BALLOON WAS SELECTED FOR USE. DURING USE, IT WAS OBSERVED THAT THE BALLOON DEFLATED SLOWLY. IT WAS IMMEDIATELY REMOVED AND EXCHANGED FOR A NEW BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950837 ↗
• MalfunctionJun 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED AORTO-ILIAC ARTERY. A 12.0 X 40, 75CM 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 22177544 ↗
• MalfunctionMay 30, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A DIALYSIS PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE SEVERELY CALCIFIED CEPHALIC ARTERY. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. UPON CHECKING, IT WAS NOTED THAT THE CONTRAST WAS LEAKING LIQUID. 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 22115389 ↗
• MalfunctionMay 26, 2025Inflation Problem; Inflation Problem

  REPOTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 29APR2025. IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON EXPANSION DID NOT FUNCTION AS INTENDED. ATTEMPTS WERE MADE TO INFLATE THE BALLOON TWO TO THREE TIMES AT APPROXIMATELY 12 ATMOSPHERES OF PRESSURE. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THE EVENT. HOWEVER, DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085014 ↗
• MalfunctionMay 6, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT PINHOLE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SHUNT. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, A SHAFT PINHOLE WAS NOTED AT NEAR THE FRONT OF THE BALLOON. THE DEVICE WAS REMOVED USING USUAL METHOD WITHOUT ISSUE 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 21970528 ↗
• MalfunctionJan 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123771 ↗
• MalfunctionJan 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL OF ILIAC. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON BURST. 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 21057318 ↗
• MalfunctionNov 24, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11NOV2024. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUBCLAVIAN VEIN. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE CONTRAST AGENT LEAKED FROM THE BOTTOM OF THE RADIO MAKER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS NORMAL POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20768071 ↗
• MalfunctionNov 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 12.0 X 40, 75CM MUSTANG WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST BEFORE REACHING THE RATED BURST PRESSURE (RB). THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED AXILLARY ARTERY. MOREOVER, THE BALLOON RUPTURED DURING SECOND INFLATION AT 18 ATMOSPHERES, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745470 ↗
• MalfunctionNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS SHUNT IN A FOREARM VESSEL. A 12.0 X 40, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE NORMAL BURST PRESSURE (NBP). THE DEVICE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723558 ↗
• MalfunctionOct 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED SUBCLAVIAN ARTERY. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE IT WAS INFLATED TO THE NOMINAL BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514764 ↗
• MalfunctionOct 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC VEIN. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 6 ATMOSPHERES FOR 15 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 20466027 ↗
• MalfunctionOct 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VEIN. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION AT LESS THAN 10 ATMOSPHERES FOR 15 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 20423466 ↗
• MalfunctionOct 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA (AVF). A 12.0 X 40, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCESS OF RAISING THE PRESSURE TO THE RATED LEVEL, THE BALLOON BURST, AND DILATATION DID NOT OCCUR. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349918 ↗
• InjurySep 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED, AND DEVICE FRAGMENT REMAINED INSIDE THE PATIENT. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT SUBCLAVIAN ARTERY. A 12.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. AFTER CONFIRMING THE RUPTURE ON THE BALLOON PART, IT APPEARED THAT THERE WAS NO PROBLEM. HOWEVER, THERE WAS A CONCERN THAT THERE MIGHT HAVE BEEN DAMAGED ON THE BALLOON PART AND A PART REMAINS INSIDE THE PATIENT. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20152361 ↗