MUSTANG™ H74939171080610Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729794714), received between Sep 16, 2022 and Jul 25, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 86% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ABDOMINAL AORTA. A 8.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER NOT EXCEEDING BURST PRESSURE IN THE FIRST INFLATION. 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 19833655 ↗
• MalfunctionJun 21, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 30MAY2024. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY VEIN, AND THE PATIENT UNDERWENT A TRANSJUGULAR PORTAL SHUNT. AN 8.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED TO DILATE A NON-BOSTON SCIENTIFIC STENT. DURING THE PROCEDURE, INDIRECT PORTAL VEIN ANGIOGRAPHY WAS CONDUCTED TO VISUALIZE THE RELATIONSHIP BETWEEN THE PORTAL VEIN AND THE LIVER VEIN. DIRECT PORTAL VEIN ANGIOGRAPHY REVEALED THAT THE MAIN PORTAL VEIN WAS UNOBSTRUCTED, THOUGH THE GASTRIC CORONARY VEIN APPEARED THICKENED AND SLUGGISH. PORTAL PRESSURE WAS RECORDED AT 37 MMHG. HOWEVER, UPON INFLATION, THE BALLOON LEAKED, AND PRESSURE COULD NOT BE MAINTAINED EVEN AFTER THE BALLOON WAS REMOVED FROM THE PATIENT. THE DEVICE WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE. HOWEVER, DEVICE RETURNED ANALYSIS REVEALED A PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19587909 ↗
• MalfunctionAug 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY. AFTER A .035 UNSPECIFIED GUIDEWIRE WAS INSERTED, AN 8.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE STENOSED TARGET LESION WAS TOTALLY OCCLUDED LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435857 ↗
• InjuryNov 8, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION OCCURRED RESULTING IN ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN CEPHALIC VEIN. AN 8.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION DURING THE TREATMENT OF AN ARTERIOVENOUS FISTULA THROMBOSIS FOR HEMODIALYSIS. HOWEVER, DURING PROCEDURE THE BALLOON FAILED TO DEFLATE. THE MAXIMUM PRESSURE HAS NOT BEEN EXCEEDED. THE PHYSICIAN TRIED TO USE INSUFFLATOR IN CONVENTIONAL WAY TO DEFLATE THE DEVICE AND SYRINGE THEREAFTER BUT FAILED. THE INSUFFLATOR USED WAS DISCONNECTED BUT THE BALLOON REMAINED FULL AND WITH SIGNIFICANT PRESSURE. THE BALLOON WAS PUNCTURED PERCUTANEOUSLY AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PATIENT WAS STABLE AND THERE WERE NO PATIENT COMPLICATIONS AND INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756393 ↗
• InjurySep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT AND UN-RETRIEVED DEVICE FRAGMENT OCCURRED; THE PATIENT EXPERIENCED PERFORATION, BLOOD LOSS, PAIN, AND VOMITING. BOTH GROINS WERE ACCESSED AND 5FR SHEATHS WERE INSERTED. THE CLOSE TO 100% STENOSED, CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED RIGHT ILIAC ARTERY IN THE COMMON-EXTERNAL ILIAC JUNCTION. A 6X60X135 MUSTANG BALLOON CATHETER WAS FIRST USED TO PREDILATE THE AREA AND THE BALLOON WAS REMOVED WITHOUT ISSUE. A 8.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS THEN ADVANCED FOR FURTHER DILATATION AND WAS HELD DILATED FOR 30 SECONDS BEFORE IT WAS DEFLATED. THE BALLOON WAS PULLED OUT WITH INTENSE CARE AS TO NOT OBSTRUCT THE VIEW OF THE AREA JUST TREATED AND THEN TOOK A SUBTRACTED RUN. A PERFORATION THEN WAS DETECTED. THE PHYSICIAN RE-ADVANCED THE SAME BALLOON BACK INTO POSITION AND RE-INFLATED UNTIL THE STENT COULD BE PREPPED FOR DEPLOYMENT. WHEN THE STENT WAS PREPPED, THE BALLOON WAS THEN DEFLATED. HOWEVER, DURING REMOVAL THE DEVICE, THE WHOLE BALLOON CAME OFF THE SHAFT. THE WIRE ALONG WITH THE SHAFT CAME COMPLETELY OUT OF THE BODY. THE PHYSICIAN RE-INSERTED THE GUIDEWIRE QUICKLY AND DEPLOYED TWO

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15437981 ↗