MUSTANG™ H74939171071070Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 08714729793779), received between Nov 16, 2018 and Jul 20, 2026 — classified as 1 injury, 69 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (63 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25884338 ↗
• MalfunctionJun 19, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL ILIAC VEIN. A 7.0 X 100, 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 25567879 ↗
• MalfunctionJun 5, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT NOMINAL PRESSURE FOR 3 SECOND. 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 25417548 ↗
• MalfunctionApr 20, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CEPHALIC ARCH. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. 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 24924699 ↗
• MalfunctionApr 15, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 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 24890483 ↗
• MalfunctionApr 9, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE SECOND INFLATION AT 12 TO 16 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 24825673 ↗
• MalfunctionMar 11, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RENAL VEIN. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573297 ↗
• MalfunctionFeb 9, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 12 ATMOSPHERES FOR 5 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293294 ↗
• MalfunctionJan 6, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED ANASTOMOSIS SITE. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 14 ATMOSPHERES FOR 30 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 23974324 ↗
• MalfunctionDec 30, 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 VESSEL IN THE LEFT FOREARM. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE FIRST INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, 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 23923595 ↗
• MalfunctionDec 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST WHILE INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 60% STENOSED, MILDLY TORTUOUS AND MODERATELY CALCIFIED. THE BALLOON WAS RUPTURED DURING FIRST INFLATION FOR 20-30 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23900966 ↗
• MalfunctionNov 24, 2025Nonstandard Device; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30OCT2025. IT WAS REPORTED THAT BALLOON FAILED TO EXPAND WELL IN THE LESION. THE 70 % STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS GRAFT. A 7.0 X 100, 75CM MUSTANG WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING SECOND INFLATION AT 20 ATMOSPHERES FOR 1 MINUTE, THE BALLOON FAILED TO EXPAND WELL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632701 ↗
• MalfunctionNov 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VEIN. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED IN A PINHOLE FORM. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23506890 ↗
• MalfunctionSep 5, 2025Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT 12 ATMOSPHERES FOR 1 MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED 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 22977896 ↗
• MalfunctionAug 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED UPPER ARM SHUNT. A 7.0 X 100, 75CM MUSTANG COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 20 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882501 ↗
• MalfunctionApr 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS (ISR) LOCATED IN THE BRACHIAL VEIN. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 20 ATMOSPHERES FOR 15 SECONDS, 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 A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21904000 ↗
• MalfunctionApr 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS (ISR) LOCATED IN THE SEVERELY CALCIFIED BRACHIAL VEIN. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 20 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. 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. IT WAS FURTHER REPORTED TARGET LESION WAS ALSO LOCATED IN A SEVERE TORTUOUS VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903992 ↗
• MalfunctionMar 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED BRACHIAL VEIN. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON VERTICALLY RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21715448 ↗
• MalfunctionMar 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED UPPER ARM GRAFT ANASTOMOSIS. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 21586284 ↗
• MalfunctionFeb 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE THIRD INFLATION AT RETED BURST PRESSURE FOR 10 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 21374820 ↗
• MalfunctionJan 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SHUNT VEIN. A 7.0 X 100, 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 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 21170006 ↗
• MalfunctionJan 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED BRACHIAL VEIN. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING SECOND INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED VERTICALLY. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 21057300 ↗
• MalfunctionOct 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING PREPARATION OUTSIDE THE PATIENT, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20564036 ↗
• MalfunctionSep 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CEPHALIC VEIN. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, ON THE FIRST INFLATION AT 8 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND NO DAMAGE WAS OBSERVED. THE RUPTURE WAS LOCATED IN THE MIDDLE PART OF THE BALLOON IN THE SHAPE OF A PINHOLE. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267441 ↗
• MalfunctionSep 19, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DIFFICULT TO DEFLATE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED BRACHIAL VEIN. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS USED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 18 ATMOSPHERES FOR 60 SECONDS ON THE FIRST ATTEMPT. HOWEVER, DEFLATION COULD NOT BE PERFORMED. THE BALLOON WAS FORCIBLY PULLED INTO THE SHEATH, BUT IT WAS DIFFICULT TO EXTRACT DUE TO INTERFERENCE BETWEEN THE SHEATH AND THE BALLOON. WHEN THE PROXIMAL SIDE OF THE BALLOON EMERGED FROM THE SHEATH, THE BALLOON WAS CUT AND SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261234 ↗