MUSTANG™ H74939171120870Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729794745), received between Mar 13, 2019 and Aug 14, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254241 ↗
• MalfunctionJul 8, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT DIFFICULTY ADVANCING OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, A RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT REMAINED STABLE POST-PROCEDURE. HOWEVER, RESULT OF THE DEVICE ANALYSIS REVEALED LONGITUDINAL TEAR IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25749332 ↗
• MalfunctionApr 9, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X 80, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835513 ↗
• MalfunctionDec 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS FISTULA. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 14 ATMOSPHERES FOR 1 MINUTE. 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 23809763 ↗
• MalfunctionAug 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, AND MODERATELY CALCIFIED CENTRAL VESSEL. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED OCCURRED JUST BEFORE REACHING THE PRESSURE. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898352 ↗
• MalfunctionFeb 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST AT A STANDARD AIR PRESSURE AND WAS NO LONGER USABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748190 ↗
• MalfunctionSep 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A DEEP VEIN. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785161 ↗
• MalfunctionMar 31, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS FISTULA. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER THE BALLOON WAS INFLATED MORE THAN THREE TIMES AT ABOVE 20 ATMOSPHERES, THE BALLOON BURST. IT WAS ALSO NOTED THAT THE MIDDLE OF THE CATHETER WAS SEPARATED OUTSIDE THE PATIENT. THE DEVICE WAS SIMPLY PULLED OUT, AND 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 16655793 ↗
• MalfunctionDec 6, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CENTRAL VEIN. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, AFTER INTRODUCING THE BALLOON THROUGH THE GUIDE WIRE AND BEING PREPARED FOR DILATION, IT WAS FOUND OUT THAT THE BALLOON WAS LEAKING LIQUID AND THERE WAS NO PRESSURE ON THE PRESSURE PUMP. THE PHYSICIAN CHECKED THE BALLOON AND FOUND OUT THAT IT WAS DAMAGED. THERE WAS NO VISIBLE PINHOLE NOTED IN EITHER THE SHAFT OR THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12938833 ↗
• MalfunctionAug 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ILIAC VEIN COMPRESSION AND LEG SWELLING. THE MILD STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ILIAC VEIN. THE PATIENT HAD ILIAC VEIN COMPRESSION. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR PRE-DILATION AND THERE WAS NO DAMAGE ON THE OUTER PACKAGE OF THE BALLOON. THE DEVICE WAS LOADED ONTO THE GUIDEWIRE AND WAS INFLATED AT LESS THAN 2 ATMOSPHERES FOR FEW SECONDS. HOWEVER, IT WAS NOTICED THAT LIQUID WAS LEAKING ON THE BALLOON AND THE PRESSURE WOULD NOT INCREASE. UPON EXAMINATION, THERE WAS PINHOLE OR TEAR ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358731 ↗
• InjuryMar 2, 2021Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE, SHAFT BREAK, AND DIFFICULTY REMOVAL OCCURRED. THE COMPLETELY OCCLUDED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT SUBCLAVIAN VEIN WITH STENT OCCLUSION. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT 12 ATMOSPHERES FOR 10-15 SECONDS, THE BALLOON RUPTURED AND WAS COMPLETELY TORN IN HALF. THE PERIPHERAL HALF OF THE BALLOON BUNCHED AND COULD NOT BE WITHDRAWN FROM THE SHEATH. A SNARE WAS ADVANCED OVER THE BALLOON AND ATTEMPTED TO REMOVE IT THROUGH THE ACCESS. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11397906 ↗
• MalfunctionJan 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION IT WAS NOTED THAT THE BALLOON FAILED TO INFLATE DUE TO A HOLE IN IT. AS PHYSICIAN STARTED TO INFLATE THE BALLOON, HE SAW THE CONTRAST MIXTURE TRAVEL INTO THE BLOOD STREAM. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11139887 ↗
• MalfunctionOct 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CENTRAL VEIN. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 9 ASMOPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPILATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738642 ↗
• MalfunctionJun 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS SITES WERE OBTAINED VIA ULTRASOUND GUIDED PUNCTURE IN THE LEFT POPLITEAL (POP) VEIN AND THE RIGHT FEMORAL VEIN. THE TARGET LESION WAS LOCATED IN THE LOWER LEFT LIMB VEIN. AFTER THE GUIDEWIRE VESSEL SHEATHS WERE PLACED, A GUIDEWIRE CROSSED THE LESION AND UPON REACHING THE VENA CAVA, THE PHYSICIAN PLACED A FILTER. THE GUIDEWIRE IN THE LEFT POP SHEATH WAS USED FOR AN ANGIOGRAM IN THE LOWER LUMEN. AFTER THE AMPLATZ GUIDEWIRE WAS REPLACED, AN ANGIOJET CATHETER WAS ADVANCED THROUGH THE GUIDEWIRE FOR POWER PULSE AND THROMBECTOMY AND THE DEVICE WAS WITHDRAWN. THE PHYSICIAN THEN ADVANCED A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER THROUGH THE GUIDEWIRE FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION, THERE WAS LOSS OF PRESSURE DESPITE SEVERAL ATTEMPTS. THE CONNECTION WAS CHECKED AND THERE WERE NO ISSUES. THE BALLOON WAS REMOVED AND IT WAS NOTED THAT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10130693 ↗
• MalfunctionDec 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9429127 ↗
• MalfunctionMar 13, 2019Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT ADVANCING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR TREATMENT AND WAS REMOVED AFTER POST-DILATATION. THE PHYSICIAN ATTEMPTED TO RE-INSERT THE DEVICE BUT FAILED TO ADVANCE THROUGH THE 7FR INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IN THE BALLOON MATERIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8416789 ↗
• MalfunctionMar 13, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15-FEB-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE TIP OF THE BALLOON CATHETER BECAME STUCK AT THE BIFURCATION OF THE ILIAC ARTERY AND THE DEVICE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8416003 ↗