MUSTANG™ H74939171030470Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729793946), received between Dec 18, 2018 and Feb 26, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0 X 40, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 18 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, 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 IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455372 ↗
• MalfunctionOct 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CEPHALIC VEIN. A 3.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 3 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20484592 ↗
• MalfunctionMay 14, 2024Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-APR-2024. IT WAS REPORTED THAT DIFFICULTY CROSSING OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 3.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON CATHETER DID NOT CROSS DUE TO THE SEVERE CALCIFIED LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PARTIAL BALLOON CIRCUMFERENTIAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315094 ↗
• MalfunctionOct 19, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-SEP-2023. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RADIAL ARTERY. A 3.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 14 ATMOSPHERES, IT WAS NOTED THAT THE PRESSURE PUMP COULD NOT FULLY INFLATE THE BALLOON. AFTER WITHDRAWAL, THE BALLOON WAS INFLATED AGAIN BUT THERE WAS LIQUID LEAKAGE FLOWING FROM THE SURFACE OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO 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 17970081 ↗
• MalfunctionAug 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA JUNCTION. A 3.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, BEFORE IT WAS INFLATED TO THE NOMINAL BAR, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651840 ↗
• MalfunctionJun 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RADIAL VEIN ARTERY. A 3.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE INFLATION, THE BALLOON RUPTURED. THE DEVICE REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181797 ↗
• MalfunctionMay 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED RADIAL VEIN. A 3.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910120 ↗
• MalfunctionMay 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. A 3.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND A BALLOON PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900051 ↗
• MalfunctionFeb 4, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26JAN2021. IT WAS REPORTED THAT A BALLOON LEAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS SUPERIOR MESENTERIC ARTERY. DUE TO THE HEAVILY CALCIFIED ARTERIES THEY WERE UNABLE TO INSERT ANOTHER MANUFACTURERS GUIDE CATHETER INTO BOTH THE COMMON FEMORAL AND COMMON ILIAC ARTERIES, SO ANGIOPLASTY OF THE RIGHT COMMON ILIAC WAS PERFORMED TO AID IN THE GUIDE CATHETER INSERTION. ANOTHER MANUFACTURES 6FR SHEATH WAS ADVANCED WITHIN THE COMMON FEMORAL ARTERY AND A .035 AMPLATZ SUPER STIFF GUIDEWIRE WAS USED TO CROSS THE LESION. THIS 3.0 X 40 75CM MUSTANG BALLOON CATHETER WAS THEN INSERTED INTO THE COMMON ILIAC ARTERY; THE MUSTANG DEVICE WAS INFLATED USING AN INFLATION DEVICE HOWEVER THE BALLOON DID NOT INFLATE AND CONTRAST WAS SEEN COMING OUT OF THE BALLOON. THE DEVICE WAS SUCCESSFULLY REMOVED WITH NO FRAGMENTS REMAINING INSIDE THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11280090 ↗
• InjuryMar 29, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT A DEFECTIVE PRODUCT CAUSED THE PATIENT INJURY. AN UNSPECIFIED BSC DEVICE WAS SELECTED FOR USE DURING A PATIENT PROCEDURE. THERE IS A SUGGESTION THAT A DEFECTIVE PRODUCT CAUSED THE PATIENT INJURY DURING THE PROCEDURE. NO FURTHER INFORMATION WAS REPORTED. IT WAS FURTHER REPORTED THAT THIS PATIENT HAD A STANDARD ENDOVASCULAR ANGIOGRAM AND ANGIOPLASTY. HOWEVER, POST-OPERATIVE IMAGING REVEALED A SMALL TUBULAR STRUCTURE AT THE VASCULAR ACCESS SITE. THE STRUCTURE WAS SURGICALLY REMOVED. THEY COULD NOT RECONCILE IT WITH ANY OF THE DEVICES USED OR THE PACKAGING. THE STRUCTURE WAS SENT TO A NON-BSC MICROSCOPY AND ANALYSIS CENTER FOR FURTHER REVIEW. THE FOREIGN MATTER WAS EXAMINED AND FOUND TO CONSIST OF A PIECE OF TUBING. THE TUBING WAS DISTORTED SO AN AVERAGE MEASUREMENT WAS CARRIED OUT. THE APPROXIMATE DIMENSIONS WERE 823UM IN DIAMETER WITH A WALL THICKNESS OF 157UM. A FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) ANALYSIS WAS CARRIED OUT TO IDENTIFY THE MATERIAL. THE TUBING WAS IDENTIFIED, BY LIBRARY MATCHING, AS A POLY(TETRAFLUOROETHYLENE), OR PTFE. THIS IS THE SAME CASE AS MDR ID 2134265-2018-00767 AND 2134265-2018-64169, AND ORIGINAL MDR ID 2134265-2018-63255.

  Patient problems: Injury

  MAUDE report 8464422 ↗
• InjuryDec 18, 2018Break; Break

  IT WAS REPORTED POST-OPERATIVE IMAGING REVEALED A SMALL TUBULAR STRUCTURE AT THE SITE OF VASCULAR ACCESS. THIS PATIENT HAD A STANDARD ENDOVASCULAR ANGIOGRAM AND ANGIOPLASTY. HOWEVER, POST-OPERATIVE IMAGING REVEALED A SMALL TUBULAR STRUCTURE AT THE VASCULAR ACCESS SITE. THE STRUCTURE WAS SURGICALLY REMOVED. THEY COULD NOT RECONCILE IT WITH ANY OF THE DEVICES USED OR THE PACKAGING. THE STRUCTURE WAS SENT TO A NON-BSC MICROSCOPY AND ANALYSIS CENTER FOR FURTHER REVIEW. THE FOREIGN MATTER WAS EXAMINED AND FOUND TO CONSIST OF A PIECE OF TUBING. THE TUBING WAS DISTORTED SO AN AVERAGE MEASUREMENT WAS CARRIED OUT. THE APPROXIMATE DIMENSIONS WERE 823UM IN DIAMETER WITH A WALL THICKNESS OF 157UM. A FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) ANALYSIS WAS CARRIED OUT TO IDENTIFY THE MATERIAL. THE TUBING WAS IDENTIFIED, BY LIBRARY MATCHING, AS A POLY(TETRAFLUOROETHYLENE), OR PTFE. IT WAS FURTHER REPORTED THAT THIS IS THE SAME CASE AS MDR ID 2134265-2018-00767 AND 2134265-2018-63255.

  Patient problems: Complaint, Ill-Defined; No Code Available

  MAUDE report 8175276 ↗