MUSTANG™ H74939171051010Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729793533), received between Sep 23, 2019 and Mar 2, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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.

• MalfunctionMar 2, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100 MM, 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. A SECOND INFLATION WAS PERFORMED AT 10 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480273 ↗
• MalfunctionMar 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100, 135CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825421 ↗
• InjuryFeb 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PART OF THE BALLOON BROKE OFF. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 035 X 260 NON-BOSTON SCIENTIFIC STIFF GUIDEWIRE WAS PLACED AND A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION WITH ENCORE INFLATION DEVICE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED THIRD TO FOURTH TIME AT 20 ATMOSPHERES IN THE CEPHALIC VEIN. HOWEVER, THE BALLOON BURST, AND A PART OF THE BALLOON WAS DETACHED IN THE RADIAL ARTERY. A SNARE WIRE WAS USED BUT IT COULD NOT REMOVE THE DETACHED COMPONENT. AFTER THAT, NO OTHER DEVICE WAS USED IN THE PROCEDURE. THE PATIENT WAS GIVEN ANTICOAGULANT MEDICINE AND HEPARIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18713915 ↗
• MalfunctionFeb 12, 2024Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29JAN2024. IT WAS REPORTED THAT BALLOON WAS LEAKING LIQUID. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. AFTER THE THROMBECTOMY PROCEDURE WAS PERFORMED. A 6F SHEATH WAS PLACED AND A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS FOUND THAT THE TIP OF THE BALLOON WAS DAMAGED AND LEAKING LIQUID. THE DEVICE WAS REMOVED AND THERE WAS NO VISIBLE DAMAGED NOTED WITH THE CATHETER, BUT THE BALLOON WAS PRESSURIZED AND FOUND THE LIQUID OOZING ON THE SURFACE. THE BALLOON WAS REPLACED WITH ANOTHER OF THE SAME DEVICE AND WAS DILATED NORMALLY. A STENT WAS IMPLANTED, AND ANGIOGRAPHY SHOWED UNOBSTRUCTED BLOOD FLOW POST-PROCEDURE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT RETURNED TO THE WARD WITH A STABLE CONDITION. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691658 ↗
• MalfunctionAug 2, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26-JUL-2023. IT WAS REPORTED THAT BALLOON LEAK WAS ENCOUNTERED. THE 70% STENOSED LONG TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 30MG HEPARIN SODIUM INJECTION WAS APPLIED VIA INTRAVENOUS INJECTION, AND A 6F SHEATH WAS EXCHANGED. A GUIDEWIRE WAS USED WITH VERTEBRAL ARTERY CATHETER TO CROSS RIGHT SFA AND REACH THE POPLITEAL ARTERY. DISTAL ANGIOGRAPHY VERIFIED THAT THE DEVICE WAS IN THE TRUE LUMEN. THROUGH THE GUIDEWIRE, BALLOONS WERE ADVANCED (4MMX80MM NON-BOSTON SCIENTIFIC AND 5.0 X 100, 135CM MUSTANG BALLOON CATHETERS) TO DILATE PART BY PART. HOWEVER, DURING INITIAL INFLATION, IT WAS NOTED THAT THE CONTRAST WAS LEAKING FROM THE BALLOON. THE DEVICE WAS REMOVED BY PULLING OUT. AFTER REPLACING THE BALLOON WITH ANOTHER OF SAME DEVICE AND DILATION WAS COMPLETED, AN AUTO-EXPANSIVE DRUG ELUTING BARE 6MMX100MM STENT WAS ADVANCED AND DEPLOYED AT THE TARGET LOCATION. THEN VIA GUIDEWIRE A 5MMX 10MM MUSTANG BALLOON CATHETER WAS ADVANCED TO DILATE. ANOTHER ANGIOGRAPHY SHOWED THAT RIGHT SFA BLOOD FLOW WAS RESTORED WITH RATHER HIGH SPEED. THERE WERE NO SIGNS OF EMBOLIZATION AT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442622 ↗
• MalfunctionJul 31, 2023Material Rupture; Material 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, BELOW THE KNEE VESSEL. A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED WHEN IT WAS CROSSING THE LESION. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424267 ↗
• MalfunctionFeb 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AFTER THE GUIDEWIRE CROSSED THE LESION, A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292586 ↗
• MalfunctionNov 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL OF SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15863754 ↗
• MalfunctionSep 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A LOWER LIMB ARTERY. A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514341 ↗
• MalfunctionFeb 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED VERTICALLY AT THE MIDDLE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508193 ↗
• MalfunctionJan 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT INTERNAL FISTULOPLASTY. THE LONG SECTION STENOSIS TARGET LESION WAS LOCATED IN THE AXILLARY ARTERY. THE PATIENT WAS NOTED WITH LONG-TERM TREATMENT OF HEMODIALYSIS, AND WAS TREATED UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). THE PHYSICIAN PUNCTURED WITH SHEATH AND PLACED NON-BOSTON SCIENTIFIC (BSC) CATHETER ALONG WITH A NON-BSC GUIDE WIRE WERE CROSSED THE LESION. SUBSEQUENTLY, A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT LESS WORKING PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND 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 13216236 ↗
• MalfunctionNov 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN SUPERIOR VENA CAVA. A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE BALLOON WAS DRAWN OUT OF THE BLOOD VESSEL, THE BALLOON CAVITY WAS DRIPPING BLOOD OUTWARD. WHEN IT WAS TESTED WITH THE PRESSURE PUMP ON THE OPERATING TABLE, THE BALLOON WAS FOUND TO BE LEAKING BLOOD AND BALLOON PINHOLE WAS NOTED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12741786 ↗
• MalfunctionJul 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, 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 NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250776 ↗
• MalfunctionNov 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED 3 TIMES AT 8 ATMOSPHERES (ATM) FOR 10 SECONDS, 12 ATM FOR 10 SECONDS AND 20 ATM FOR 30 SECONDS RESPECTIVELY. HOWEVER, DURING THIRD INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10858628 ↗
• MalfunctionSep 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10572331 ↗
• MalfunctionSep 7, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTY OCCURRED. VASCULAR ACCESS WAS OBTAINED BY CONTRALATERAL APPROACH. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AFTER A 6F NON-BSC SHEATH WAS IN PLACE AND A NON-BSC GUIDEWIRE CROSSED THE LESION, DILATION WAS PERFORMED USING A 3MM COYOTE BALLOON CATHETER AND A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS USED FOR SIZE UP DILATION. HOWEVER, IT WAS NOTED THAT THE MUSTANG BALLOON CATHETER WAS UNABLE TO REMOVE. IT SEEMED THAT IT GOT CAUGHT IN THE Y CONNECTOR. SEVERAL ATTEMPTS SUCH AS REINSERTION AND INFLATING REPEATEDLY WERE PERFORMED, BUT FAILED. THE DEVICE WAS REMOVED TOGETHER WITH THE SHEATH AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10499569 ↗
• MalfunctionAug 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 5 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10469304 ↗
• MalfunctionMar 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE LITTLE TORTUOUS AND VERY HARD CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 24 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9906212 ↗
• MalfunctionMar 30, 2020Material Rupture; Material 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 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 15 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 Consequences Or Impact To Patient

  MAUDE report 9900816 ↗
• MalfunctionFeb 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED WITH CONTRALATERAL FIRAMINAL APPROACH. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9684853 ↗
• MalfunctionSep 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X 100MM, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE 6TH INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9104757 ↗