MUSTANG™ H74939171120810Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729795285), received between Nov 28, 2018 and Jun 19, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (16 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27MAY2026. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON COULD NOT BE OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25567870 ↗
• MalfunctionDec 10, 2025Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20NOV2025. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON COULD NOT BE DILATED WHEN IT REACHED THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771641 ↗
• MalfunctionJul 21, 2025Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02JUL2025. IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE IN THE ARTERIAL STENTING OF THE LOWER EXTREMITY. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON DID NOT RESPOND IN THE PROCESS OF INFLATING WITH THE PRESSURE PUMP IN VIVO. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE LOCATED APPROXIMATELY 12MM DISTAL FROM THE DISTAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553119 ↗
• InjuryApr 2, 2025Difficult 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 BALLOON BURST, DIFFICULT TO REMOVE FROM THE GUIDE, AND SURGERY OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED ENDOVASCULAR PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS POSITIONED AND INFLATED, BUT THE BALLOON BURST. UPON REMOVAL, IT BECAME STUCK WITH THE GUIDE. THE BALLOON WAS NOT SUCCESSFULLY REMOVED, AND THERE WERE FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SHIFTED FROM ENDOVASCULAR TO AN OPEN SURGICAL PROCEDURE TO TREAT THE ARTERIOVENOUS FISTULA.

  Patient problems: Foreign Body In Patient

  MAUDE report 21755959 ↗
• MalfunctionMay 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% TARGET LESION WAS LOCATED IN THE MILD TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS ADVANCED TO THE LESION ALONG THE GUIDEWIRE. AT 12ATM, THE BALLOON DOES NOT SHOW ANY IMAGE INSIDE THE PATIENT AND WAS FOUND TO BE BURST OUTSIDE THE PATIENT'S BODY. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A BSC WALLSTENT. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322701 ↗
• MalfunctionDec 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED COMMON ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 10 ATMOSPHERES FOR LESS THAN A MINUTE, THE BALLOON RUPTURED. 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 18390495 ↗
• MalfunctionNov 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INFLATION, WHEN THE PRESSURE REACHED AT 18 ATMOSPHERES, THE DEVICE RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MORE THAN 90% STENOSED. THE BALLOON RUPTURED DURING THE SECOND INFLATION FOR 8-15 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057328 ↗
• MalfunctionMay 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 10 ATMOSPHERES FOR 30 SECOND, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007170 ↗
• MalfunctionSep 23, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT BALLOON LEAK AND INFLATION PROBLEM WERE ENCOUNTERED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT NOMINAL PRESSURE, THE BALLOON COULD NOT BE FULLY INFLATED. AFTER REMOVAL, IT WAS FOUND THAT THE BALLOON WAS LEAKING FLUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470132 ↗
• MalfunctionMar 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. TH PATIENT PRESENTED WITH THROMBOSIS. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657615 ↗
• MalfunctionFeb 21, 2022Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04FEB2022. IT WAS REPORTED THAT INFLATION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON COULD NOT BE DEPLOYED PROPERLY AFTER PRESSURE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573127 ↗
• MalfunctionFeb 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13519151 ↗
• MalfunctionFeb 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. 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

  MAUDE report 13500446 ↗
• MalfunctionJan 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND 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 13291417 ↗
• MalfunctionDec 1, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS TREATED FOR DEEP VEIN THROMBOSIS FOR STENOTIC LESION IN THE LEFT LOWER EXTREMITY. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS SELECTED FOR PRE-DILATION. HOWEVER, AFTER THE BALLOON WAS INTRODUCED THROUGH THE GUIDE WIRE, THE BALLOON WAS LEAKING LIQUID AND PRESSURE COULD NOT COME UP. THE BALLOON WAS FOUND TO BE DAMAGED UPON CHECKING. THE DEVICE WAS REPLACED WITH ANOTHER 12MMX80MM MUSTANG BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED ONCE IN LESS WORKING PRESSURE FOR A FEW SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907926 ↗
• MalfunctionAug 3, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN VISUALIZING THROUGH ANGIOGRAPHY, THE BALLOON DID NOT EXPAND. WHEN THE BALLOON WAS REMOVED, IT WAS OBSERVED THAT IT WAS BROKEN. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272169 ↗
• MalfunctionNov 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, ON INITIAL INFLATION AT 13 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10818163 ↗
• InjuryJul 15, 2020Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE, SHAFT BREAK AND RIPPED/DAMAGE VESSEL OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ILIAC ARTERY. THROMBECTOMY WAS DONE USING ZELANTE DVT THROMBECTOMY CATHETER. AFTER CLEARING THE CLOT, A 10.0 X 80, MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. NEXT, PLACEMENT OF TWO 14X 90 WALLSTENT WERE IMPLANTED SINCE STENOSIS WAS LONG. AFTER STENTING, POST-DILATATION WAS ATTEMPTED WITH A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER. THE BALLOON WAS INFLATED TWICE; HOWEVER, DURING SECOND INFLATION AT 12 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE PHYSICIAN TRIED TO PULLED OUT THE BALLOON BUT HAD A LOT OF RESISTANCE SINCE BALLOON BEGAN TO CRUMBLED UP. THE PHYSICIAN PULLED THE BALLOON OUT BREAKING THE SHAFT INTO 3 PARTS, AND ABOUT 90% OF THE ACTUAL BALLOON WAS LEFT INSIDE THE PATIENT. IT DID NOT FIT THROUGH A 10FR INTRODUCER SHEATH, SO THE PHYSICIAN CHANGED TO A 11FR INTRODUCER SHEATH TO TRY AND PULLED IT BACK, BUT WAS UNABLE TO. HE FINALLY TOOK OUT THE INTRODUCER SHEATH AND WAS ABLE TO SECURE THE SOUL OF THE BALLOON. WHEN EXTRACTING THE LAST PART OF THE B

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 10279021 ↗
• MalfunctionDec 23, 2019Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A HOLE ON THE BALLOON WAS NOTED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE BALLOON WAS LEAKING AND HAD A HOLE ON IT. THE BALLOON WAS SIMPLY REMOVED FROM THE PATIENT'S BODY AND 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 9511738 ↗
• MalfunctionAug 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LLIAC VEIN. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION AT 14 ATMOSPHERES FOR SEVERAL SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8871801 ↗
• InjuryNov 28, 2018Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT LOWER EXTREMITY. A 12.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON BURST AND DETACHED INTO TWO PARTS. HALF REMAINED INSIDE THE PATIENT AND SURGERY WAS PERFORMED TO TAKE THE FRAGMENTS OUT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112576 ↗