MUSTANG™ H74939171070870Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729794264), received between Jul 26, 2019 and Feb 3, 2026 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (26 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED WITHIN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED AV SHUNT. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE FIRST INFLATION, THE BALLOON WAS RUPTURED BEFORE THE NOMINAL BURST PRESSURE WAS REACHED. 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 24245892 ↗
• MalfunctionDec 8, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745756 ↗
• MalfunctionNov 12, 2025Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21OCT2025. IT WAS REPORTED THAT A LOT OF RESISTANCE WAS FELT UPON ADVANCING IN THE SHEATH. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WERE A LOT OF RESISTANCE UPON ADVANCING IN THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531967 ↗
• MalfunctionAug 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN ARTERIOVENOUS FISTULA. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST WHILE INFLATING IT INSIDE THE PATIENT'S BODY. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827123 ↗
• MalfunctionMar 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST BEFORE THE PRESSURE WAS REACHED DURING INFLATION. 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 21643487 ↗
• MalfunctionMar 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON BURST BEFORE REACHING PRESSURE. 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 21504119 ↗
• MalfunctionNov 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 7.0 X 80, 75CM MUSTANG WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST WHILE INFLATING INSIDE THE PATIENT'S BODY. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597257 ↗
• MalfunctionOct 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED OCCURRED. A 7.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT 18 ATMOSPHERES, THE BALLOON BURST. 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 20456468 ↗
• MalfunctionSep 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RADIAL VEIN. A 7.0 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 COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80% STENOSED, MODERATELY TORTUOUS, AND SEVERELY CALCIFIED. ADDITIONALLY, THE BALLOON WAS INFLATED MORE THAN 3 TIMES AT 20 ATMOSPHERES FOR 2 MINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295670 ↗
• MalfunctionSep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED ARTERIOVENOUS SHUNT. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INFLATION, THE BALLOON BURST BEFORE REACHING NORMAL BURST PRESSURE. 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 20255214 ↗
• MalfunctionJun 25, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT WATER LEAKAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS LEAKING WATER. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE SIXTH 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 REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PINHOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607766 ↗
• MalfunctionSep 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823381 ↗
• MalfunctionMar 22, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED UPPER ARM ARTERIOVENOUS FISTULA. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588849 ↗
• MalfunctionFeb 16, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE (B)(4)% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MILDLY CALCIFIED RADIAL ARTERIOVENOUS FISTULA. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT RATED BURST PRESSURE FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384938 ↗
• MalfunctionNov 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERIOVENOUS FISTULA. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, DURING THE FIRST INFLATION AT 16 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707663 ↗
• MalfunctionOct 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN RADIAL ARTERIOVENOUS FISTULA VEIN. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705122 ↗
• MalfunctionOct 24, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-SEP-2022. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS ARTERIOVENOUS FISTULA. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662151 ↗
• MalfunctionJul 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, 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 15047868 ↗
• MalfunctionDec 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED.. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 20 ATMOSPHERES. IT WAS FURTHER REPORTED THAT THE LESION WAS 70% STENOSED AND WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112903 ↗
• MalfunctionSep 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED IN A MODERATELY TORTUOUS AND NON-CALCIFIED RADIAL ARTERY. THE BALLOON RUPTURED ON THE SECOND INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502330 ↗
• MalfunctionSep 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED RADIAL ARTERY. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT APPROXIMATELY 10-12 ATMOSPHERES, THE BALLOON RUPTURED AND CONTRAST LEAKAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12464905 ↗
• MalfunctionSep 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS SHUNT IN THE UPPER LIMB. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST WHEN THE ATMOSPHERIC PRESSURE WAS 20 KPA. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12430978 ↗
• MalfunctionAug 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SHUNT VESSEL. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING FIRST INFLATION AT 8 ATMOSPHERES FOR 60 SECONDS.THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IT WAS FURTHER REPORTED THAT IT WAS ABOUT 60% STENOSED, NON CALCIFIED, AND MODERATELY TORTUOUS TARGET LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271419 ↗
• MalfunctionJun 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10197084 ↗
• MalfunctionApr 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE UPPER VEIN OF THE LEFT ARM ELBOW. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9955616 ↗