MUSTANG™ H74939171071570Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729794578), received between Apr 17, 2019 and Mar 22, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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.

• MalfunctionMar 22, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 7.0 X 150, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THERE WAS NO PROBLEM WITH THE INITIAL BALLOON DILATION, BUT AFTER USING A CONTRAST AGENT TO IMAGE THE DILATED AREA, SOME RESIDUAL STENOSIS WAS OBSERVED. WHEN ATTEMPTING TO USE THE BALLOON AGAIN AT NOMINAL PRESSURE, IT BURST ON THE ANGIOGRAPHIC SCREEN AND THE CONTRAST AGENT LEAKED OUT. THE BALLOON WAS REMOVED FROM THE PATIENT AND TESTED OUTSIDE THE BODY, CONFIRMING THAT THE BALLOON TORE AND COULD NOT BE DILATED. 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 24658992 ↗
• MalfunctionAug 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A MUSTANG 7.0 X 150, 75CM WAS ADVANCED FOR DILATATION. DURING TREATMENT, BALLOON BURST AT 25ATM AFTER A MINUTE LATER. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898367 ↗
• MalfunctionNov 12, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE AXILLARY ARTERY. A 7.0 X 150, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AND LEAKED BEFORE REACHING THE NOMINAL ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 20662605 ↗
• MalfunctionJul 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RADIAL ARTERIOVENOUS FISTULA (AVF). A 7.0 X 150, 75CM MUSTANG BALLOON WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. HOWEVER, DURING THE SECOND INFLATION FOR 30 SECONDS, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND 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 19793923 ↗
• InjuryJun 13, 2024Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE AND DIFFICULTY IN REMOVAL OCCURRED. A 7.0 X 150, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR A FISTULA DECLOT. IT WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED ONCE BUT DID NOT REACH ITS NOMINAL PRESSURE BEFORE IT BURST AND BECAME LODGED, MAKING REMOVAL FROM THE SHEATH IMPOSSIBLE. THE DOCTOR ATTEMPTED TO REMOVE THE BALLOON BUT WAS UNSUCCESSFUL. CONSEQUENTLY, VASCULAR SURGERY WAS CALLED, AND THE PATIENT REQUIRED EMERGENCY SURGERY FOR REMOVAL. THE PATIENT UNDERWENT AN EMERGENCY CUTDOWN PROCEDURE, AND THE MUSTANG BALLOON WAS SUCCESSFULLY REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533421 ↗
• MalfunctionMar 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED FOR ARTERIOVENOUS GRAFT (AVG) ANGIOPLASTY. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL IN THE LEFT UPPER LIMB. A 7.0 X 150, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MUSTANG BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16514814 ↗
• MalfunctionDec 7, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THE BALLOON BURST CIRCUMFERENTIALLY AND DETACHED. A 7.0 X 150, 75CM MUSTANG BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE 90% STENOSED, MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE FIRST INFLATION, THE BALLOON BURST CIRCUMFERENTIALLY APPROXIMATELY 5CM FROM THE TIP. DURING REMOVAL, THE DISTAL PORTION BROKE OFF AND WAS ABLE TO BE REMOVED FROM THE PATIENT STILL ON THE GUIDEWIRE WITH OUT ANY COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953475 ↗
• MalfunctionDec 31, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERIOR FEMORAL ARTERY. AFTER CROSSING A V18 GUIDE WIRE, A 7.0 X 150, 75CM MUSTANG CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REPLACED WITH ANOTHER MUSTANG BALLOON AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9534750 ↗
• MalfunctionApr 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY AND COMMON FEMORAL ARTERY. AFTER A NON-BSC GUIDEWIRE CROSSED THE LESION, A 7.0 X 150, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, THE BALLOON RUPTURED WITHIN THE SPECIFIED PRESSURE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524353 ↗