MUSTANG™ H74939171090870Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729794868), received between Apr 15, 2019 and Dec 8, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 9.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE, THE BALLOON BURST. 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 23745622 ↗
• MalfunctionSep 2, 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 CENTRAL VEIN. A 9.0 X 80, 75CM MUSTANG BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE SECOND INFLATION FOR 1 MINUTE, JUST BEFORE REACHING THE DESIRED PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935800 ↗
• MalfunctionJan 21, 2025Material Rupture; Material Rupture

  IT VWAS REPORTED BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUBCLAVIAN VESSEL. A 9.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, A BURST OCCURRED AS THE PRESSURE WAS GRADUALLY INCREASED TO THE BURST PRESSURE LEVEL. 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 21201323 ↗
• MalfunctionAug 9, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION TIME WAS SLOW. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 9.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, BALLOON DEFLATION TIME WAS TOO SLOW. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19952295 ↗
• MalfunctionMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 9.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374995 ↗
• MalfunctionMar 15, 2024Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 9.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. PRIOR TO PROCEDURE, THE BALLOON DID NOT TRACK SMOOTHLY OVER A NON-BSC GUIDEWIRE, IT WAS STICKING. THEN, UPON INFLATION THE BALLOON BURST AT 18 ATMOSPHERES. THE DEVICE COULD NOT BE REMOVED, BUT THE PHYSICIAN ABLE TO RESHEATH THROUGH A 10F SHEATH AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914106 ↗
• MalfunctionFeb 20, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME ENTRAPPED ON THE GUIDEWIRE. MUSTANG 9.0 X 80, 75CM BALLOON WAS SELECTED FOR THE INDEX PROCEDURE. THE BALLOON WAS USED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. UPON REMOVAL, HOWEVER, PART OF THE SHEATH REMAINED ATTACHED TO THE GUIDEWIRE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406063 ↗
• MalfunctionJan 9, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS ARTERIOVENOUS FISTULA. A 9.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE LESION BECAUSE THE LESION WAS TIGHT AND CALCIFIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122119 ↗
• MalfunctionNov 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE AXILLARY VEIN. A 9.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10862208 ↗
• MalfunctionFeb 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUBCLAVIAN VEIN. A 9.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9656548 ↗
• MalfunctionApr 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE ARM. A 9.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515897 ↗