MUSTANG™ H74939171100810Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729795254), received between Aug 20, 2018 and Sep 21, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Fluid/Blood Leak; Material Rupture

  It was reported that balloon leak and rupture occurred.The more than 90% stenosed target lesion was located in the left superficial femoral artery. A 10.0 x 80, 135cm MUSTANG balloon catheter was advanced for dilation. During inflation at 12 atmospheres, the balloon was noted to have an irregular configuration, failing to achieve the desired dilatation effect, and contrast extravasation was visible from the site of balloon rupture. The balloon was fully deflated, and the ruptured balloon catheter was safely withdrawn along with the guidewire. The procedure was completed with another of the same device. There were no patient complications as a result of this event. The patient remained stable following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842870 ↗
• InjuryMar 5, 2026Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT, DIAGNOSED WITH DEEP VEIN THROMBOSIS IN THE RIGHT LOWER EXTREMITY AND PULMONARY EMBOLISM, UNDERWENT PLACEMENT OF AN INFERIOR VENA CAVA FILTER, ASPIRATION OF THE RIGHT LOWER-EXTREMITY THROMBUS, AND CATHETER-DIRECTED THROMBOLYSIS. THE TARGET LESION WAS LOCATED IN THE RIGHT LOWER EXTREMITY. A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR VESSEL DILATATION. AFTER INSERTION OF THE PTA BALLOON CATHETER, CONTRAST WAS INJECTED USING A DISPOSABLE INFLATION DEVICE. THE BALLOON DID NOT ACHIEVE FULL INFLATION, AND THE PATIENT REPORTED PAIN AND NUMBNESS IN THE AFFECTED LIMB. THE DEVICE WAS EMPTIED AND REMOVED FROM THE PATIENT. UPON INSPECTION, THE BALLOON WAS FOUND TO BE DAMAGED. A SMALL RUPTURE MEASURING LESS THAN 1 MM WAS OBSERVED ON THE BALLOON SURFACE, WITH CONTRAST NOTED TO BE LEAKING IN A THIN STREAM. THE PROCEDURE WAS DISCONTINUED TO PREVENT COMPLICATIONS. THROMBOLYSIS WAS SUBSEQUENTLY CONTINUED USING A PERFUSION SYSTEM. NO FURTHER ADVERSE EVENTS WERE REPORTED, AND THE PATIENT WAS SAFELY RETURNED TO THE WARD.

  Patient problems: Numbness; Pain

  MAUDE report 24520550 ↗
• MalfunctionJul 28, 2025Material 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 80% STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS PULLED DIRECTLY FROM THE SHEATH AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639031 ↗
• MalfunctionJan 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARM VESSEL. A 10.0 X 80, 135CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE WORKING PRESSURE WAS NOT REACHED, AND THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118383 ↗
• MalfunctionJan 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL OF THE ARM. A 10.0 X 80, 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE WORKING PRESSURE WAS NOT REACHED AND THE BALLOON RUPTURED. 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 21112574 ↗
• MalfunctionJan 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARM VESSEL. A 10.0 X 80, 135CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST BEFORE REACHING THE WORKING PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21100564 ↗
• MalfunctionJul 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS). A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT NO MORE THAT THE BURST PRESSURE FOR 10 SECONDS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH A LOCAL ANESTHESIA. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818587 ↗
• InjuryJun 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED VIA MEDWATCH MW5154551 THAT BALLOON AND VESSEL RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE EXTERNAL ILIAC ARTERY. A 10.0 X 80, 135CM MUSTANG BALLOON WAS ADVANCED FOR POST-DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED. CONSEQUENTLY, A VESSEL RUPTURE OCCURRED AT THE SAME TIME AND LOCATION OF THE BALLOON RUPTURE. THE PATIENT WAS HOSPITALIZED.

  Patient problems: Perforation of Vessels

  MAUDE report 19533017 ↗
• MalfunctionDec 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERIOR VENA CAVA. A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS, THE BALLOON BURST. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352260 ↗
• MalfunctionNov 17, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13-NOV- 2023. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN SUPERIOR VENA CAVA. A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS LEAKING BEFORE THE BURSTING PRESSURE WAS REACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161848 ↗
• MalfunctionOct 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED THE OCCLUDED TARGET LESION WAS LOCATED IN ILIAC FEMORAL VEIN. A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, BEFORE THE PRESSURE REACHING THE STANDARD, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE BODY IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668593 ↗
• MalfunctionDec 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, SHARP PLAQUE WERE ENCOUNTERED AND DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED ONCE AT LESS WORKING PRESSURE FOR FEW SECONDS BEFORE IT RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12987406 ↗
• MalfunctionApr 8, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16-MAR-2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. AFTER INSERTING A 6F INTRODUCER SHEATH AND A 0.035 GUIDEWIRE, THROMBOSIS ASPIRATION WAS PERFORMED WITH A ANGIOJET THROMBECTOMY SYSTEM. THE INTRODUCER SHEATH WAS REPLACED WITH A 9F SHEATH AND A 8.0 X 80 MUSTANG BALLOON CATHETER USED TO PRE-DILATE THE LESION. A 10 X 80 SELF-EXPANDING STENT WAS IMPLANTED FOLLOWED BY A 12 X 90 WALLSTENT VENOUS STENT. SUBSEQUENTLY, A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING INFLATION AT 4 ATMOSPHERES, CONTRAST AGENT LEAKAGE WAS FOUND. 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. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633804 ↗
• MalfunctionDec 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE SPLEEN. A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 10-20 ATMOSPHERES FOR A FEW SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11001898 ↗
• MalfunctionDec 1, 2020Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. AFTER A GUIDEWIRE WAS CROSSED THE LESION, A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS INFLATED AT RATED PRESSURE, THE CONTRAST AGENT WAS FOUND TO LEAK. THE DEVICE WAS REMOVED AND A PINHOLE WAS NOTICED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10930840 ↗
• MalfunctionAug 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS SHUNT IN A MILDLY TORTUOUS AND NON-CALCIFIED VESSEL. A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 7 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799721 ↗