MUSTANG™ H74939171052010Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729793373), received between Oct 7, 2018 and Dec 31, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04DEC2025. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION LOCATED IN THE LOWER EXTREMITY ARTERY WAS PREPARED BY MANUAL HEPARIN-SALINE INFUSION AND IRRIGATION. A 5.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS THEN ADVANCED FOR DILATATION BUT DURING PRESSURIZATION, THE BALLOON COULD NOT BE EXPANDED NORMALLY, AND ANGIOGRAPHY SHOWED CONTRAST MEDIUM LEAKAGE; HOWEVER, NO PHYSICAL DAMAGE WAS NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON CATHETER. NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION WERE STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933208 ↗
• MalfunctionDec 22, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ENTRAPMENT OCCURRED. A 5.0 X 200 MM, 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE DEVICE BECAME STUCK AND COULD NOT BE REMOVED. THE PHYSICIAN PROCEEDED TO WITHDRAW THE ENTIRE SYSTEM, INCLUDING THE GUIDEWIRE AND BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871400 ↗
• MalfunctionAug 4, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BALLOON FAILURE TO DEFLATE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS ADVANCED AND INFLATED TO 16 ATMOSPHERES. ATTEMPTS TO DEFLATE THE BALLOON WERE UNSUCCESSFUL, AND IT REMAINED INFLATED FOR 5 MINUTES WHILE STILL INSIDE THE PATIENT. THE BALLOON WAS REMOVED TOGETHER WITH THE INTRODUCER IN A SINGLE MOVEMENT AND THE PROCEDURE COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702099 ↗
• MalfunctionMar 3, 2025Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT LOWER EXTREMITY ARTERIAL STENOSIS. A 5.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. DURING INFLATION AT 8 ATMOSPHERES, IT WAS NOTED THAT CONTRAST MEDIUM OVERFLOW AT THE TIP OF THE BALLOON. THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY. UPON VISUAL INSPECTION, FLUID LEAKAGE WAS NOTED, HOWEVER, THERE WAS NO PINHOLE NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE LOCATED APPROXIMATELY 4MM DISTAL FROM THE DISTAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504109 ↗
• MalfunctionJun 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER FEMORAL ARTERY. A 5.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80% STENOSED, MODERATELY TORTUOUS AND SEVERELY CALCIFIED. THE BALLOON WAS RUPTURED DURING FIRST INFLATION AT 7 ATMOSPHERES FOR 10-20 SECONDS. THE BALLOON WAS REMOVED NORMALLY FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518326 ↗
• MalfunctionOct 11, 2022Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-SEP-2022. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED POPLITEAL ARTERY. A 5.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES, THE CONTRAST MEDIUM WAS STARTED TO LEAK FROM THE BALLOON AND THE PRESSURE READING IN THE INFLATION DEVICE DECREASED. AFTER THE BALLOON WAS DEFLATED AND REMOVED, BLOOD WAS NOTED INSIDE THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER 5 X 100 MUSTANG BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584865 ↗
• MalfunctionJan 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMRAL ARTERY. A 5.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 24 ATMOSPHERES FOR BELOW 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13234603 ↗
• MalfunctionDec 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, IT WAS FURTHER REPORTED THAT THE BALLOON WAS INITIALLY INFLATED IN A LESS WORKING PRESSURE BEFORE IT BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924134 ↗
• MalfunctionDec 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 22 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11094430 ↗
• MalfunctionOct 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10706288 ↗
• MalfunctionNov 11, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT A BALLOON FAILED TO DEFLATE. A PROCEDURE WAS BEING PERFORMED VIA CONTRALATERAL APPROACH TO TREAT A LESION IN THE SUPERIOR FEMORAL ARTERY. THE 5.0 X 200 X 135CM MUSTANG BALLOON WAS INFLATED TWO OR THREE TIMES AND THEN AFTER THE FINAL INFLATION, IT WOULD NOT DEFLATE. THE DEVICE BECAME STUCK INSIDE THE INTRODUCER SHEATH AND THE BALLOON STRETCHED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND NO ADDITIONAL BALLOON WAS REQUIRED. THE PATIENT WAS NOTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9305823 ↗
• MalfunctionSep 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200, 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON LEAKED AND PINHOLE WAS NOTED ON THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH A 6 X 200 MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8986395 ↗
• MalfunctionJul 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200 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 Consequences Or Impact To Patient

  MAUDE report 8775881 ↗
• MalfunctionMay 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). TWO NON BSC STENT BALLOON WERE ADVANCED TO THE TARGET LESION AND RUPTURED. A 5.0 X 200, 135 CM MUSTANG WAS THEN USED TO DILATE THE TARGET LESION AND ON THE FIRST INFLATION, UNDER RATED BURST PRESSURE (RBP), THE BALLOON BURST. IT WAS NOTED THAT THE CALCIFICATION LIKELY CAUSED THE BALLOON TO BURST. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT AND THE PATIENT STATUS WAS OKAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8604409 ↗
• MalfunctionOct 7, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). AFTER A NON-BSC GUIDE WIRE CROSSED THE LESION, A 4MM BALLOON CATHETER WAS ADVANCED FOR DILATATION. SINCE DILATATION WITH 4MM BALLOON CATHETER WAS NOT SUFFICIENT, A 5.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS USED TO DILATE THE DISTAL SFA. AFTER THAT, THE SAME BALLOON WAS ALSO USED TO DILATE THE PROXIMAL SFA; HOWEVER, ON THE SECOND INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7941596 ↗