MUSTANG™ H74939171100670Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729794004), received between Dec 5, 2019 and Sep 21, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Rupture

  It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel. A 10.0 x 60, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured at 8 atmospheres. 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 50836565 ↗
• MalfunctionJun 8, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE OVER 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ARTERIOVENOUS FISTULA. A 10.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION UNDER 14 ATMOSPHERES FOR 30 SECONDS, 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 25430727 ↗
• MalfunctionApr 27, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION, EXHIBITING 100% STENOSIS, WAS LOCATED IN A NON-TORTUOUS AND MILDLY CALCIFIED CENTRAL VEIN. A 10.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED BEFORE REACHING ITS NOMINAL BURST PRESSURE (NBP). 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 25000178 ↗
• MalfunctionFeb 20, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 10.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. 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 24405110 ↗
• MalfunctionJan 6, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 10.0 X 60, 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. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972886 ↗
• MalfunctionSep 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL VEIN. A 10.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PTA 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. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, SEVERELY TORTUOUS, AND SEVERELY CALCIFIED. THE BALLOON RUPTURED DURING SECOND INFLATION AT 16 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED BY PULLING THE DEVICE OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23101543 ↗
• MalfunctionMay 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 50-60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUBCLAVIAN ARTERY. A 10.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON BURST DURING INITIAL INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DEFLATED AND THEN REMOVED FROM THE TARGET LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003326 ↗
• MalfunctionJul 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CEPHALIC VEIN. A 10.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES WITHIN 10 SECONDS, THE BALLOON BURST. THE DEVICE WAS PULLED BACK AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740390 ↗
• MalfunctionMay 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE CENTRAL VEIN. A 10.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234272 ↗
• MalfunctionNov 17, 2023Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15-NOV-2023. IT WAS REPORTED THAT ADVANCING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS COMMON ILIAC ARTERY. A 10.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE DEVICE DID NOT MOVE IN THE OPPOSITE DIRECTION DURING THE CONTRALATERAL APPROACH PROCESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162328 ↗
• MalfunctionDec 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. TWO 10.0 X 60, 75CM AND ONE 10.0 X 40, 75CM MUSTANG BALLOON CATHETERS WERE SELECTED TO TREAT THE LESION. HOWEVER, THE BALLOONS RUPTURED UPON INFLATION DESPITE BEING HIGH-PRESSURE BALLOONS. THE PROCEDURE WAS COMPLETED A NON-BOSTON SCIENTIFIC BALLOON CATHETER. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957562 ↗
• MalfunctionDec 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. TWO 10.0 X 60, 75CM AND ONE 10.0 X 40, 75CM MUSTANG BALLOON CATHETERS WERE SELECTED TO TREAT THE LESION. HOWEVER, THE BALLOONS RUPTURED UPON INFLATION DESPITE BEING HIGH-PRESSURE BALLOONS. THE PROCEDURE WAS COMPLETED A NON-BOSTON SCIENTIFIC BALLOON CATHETER. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957557 ↗
• MalfunctionFeb 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 10.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. NO BALLOON FRAGMENTS WERE LEFT IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS FINE. IT WAS FURTHER REPORTED THAT THE TARGET LESION HAD 60% STENOSIS AND WAS NON-TORTUOUS AND MILDLY CALCIFIED. THE BALLOON RUPTURED UPON INITIAL INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266866 ↗
• MalfunctionFeb 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS SHUNT. A 10.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT NOMINAL PRESSURE,THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9756596 ↗
• MalfunctionDec 5, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CENTRAL VEIN. A 10.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE BALLOON AND CATHETER WERE TOTALLY BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT CONDITION WAS NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9415876 ↗