MUSTANG™ H74939171040870Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729794363), received between Jan 23, 2019 and Jan 19, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Inflation Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED O THE DEVICE ANALYSIS COMPLETED ON 23DEC2026. IT WAS REPORTED THAT FAILURE TO INFLATE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERE ARTERIOVENOUS FISTULA. A 4.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE CATHETER FAILED TO FULLY EXPAND AT 23 ATMOSPHERE. THE PROCEDURE WAS COMPLETED USING WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED CIRCUMFERENTIAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111638 ↗
• MalfunctionSep 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN ARTERIOVENOUS FISTULA. A MUSTANG 4.0 X 80, 75CM WAS SELECTED FOR USE. DURING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, THE BALLOON WAS RUPTURED. 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. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, SEVERELY TORTUOUS AND SEVERELY CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23108783 ↗
• MalfunctionSep 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A MUSTANG 4.0 X 80, 75CM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON BURST UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. 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 22983104 ↗
• MalfunctionNov 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY ARTERY. A 4.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST UPON FIRST INFLATION AT 20 ATMOSPHERES FOR 10 SECONDS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213245 ↗
• MalfunctionAug 16, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 4.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE WITH A SALINE-CONTRAST RATIO OF 3:7, IT WAS OBSERVED THAT THE BALLOON WAS INFLATED AT 17 ATMOSPHERES AND DID NOT DEFLATE PERFECTLY. THE BALLOON WAS COMPLETELY REMOVED IN A DEFLATED STATE THROUGH THE SHEATH AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558852 ↗
• MalfunctionJul 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LIMB ARTERY. A 4.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON HAD A HOLE AND WAS UNABLE TO INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17366341 ↗
• MalfunctionJun 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 4.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, IT COULD NOT INFLATE BECAUSE THERE WAS A HOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036093 ↗
• InjuryJan 4, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK, AND BALLOON RUPTURE OCCURRED REQUIRING A SURGICAL INTERVENTION. THE TARGET LESION WAS LOCATED IN ARTERIOVENOUS FISTULA. A 4.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS INFLATED MORE THAN RATED BURST PRESSURE, THE BALLOON RUPTURED, AND THE SHAFT WAS BROKEN. THE BROKEN PIECES OF THE CATHETER WERE LEFT INSIDE THE PATIENT'S VESSEL, AND SURGICAL INTERVENTION WAS PERFORMED TO RETRIEVE THE BROKEN PIECES. THE PROCEDURE WAS COMPLETED AFTER REMOVAL OF THE CATHETER FRAGMENTS. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED, AND THE PATIENT IS AT RECOVERY STAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095401 ↗
• MalfunctionJan 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 4.0 X 8, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 24 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270642 ↗