MUSTANG™ H74939171090270Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729793755), received between Mar 7, 2019 and Mar 13, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (22 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 16 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595664 ↗
• MalfunctionDec 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR LESION DILATATION. DURING THE PROCEDURE, BALLOON RUPTURE OCCURRED WITHIN A CALCIFIED ILIAC ARTERY CHRONIC TOTAL OCCLUSION (CTO). THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860293 ↗
• MalfunctionNov 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569763 ↗
• MalfunctionOct 7, 2025Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BLUE MATERIAL WAS FOUND UPON FLUSHING. A 9.0 X 20, 75CM MUSTANG WAS SELECTED FOR USE IN A PROCEDURE. DURING DEVICE PREPARATION, BLUE MATERIAL WAS OBSERVED DURING FLUSHING. THE SOURCE OF THE MATERIAL COULD NOT BE CONFIRMED, HOWEVER, THE CUSTOMER REPORTED THAT IT APPEARED TO HAVE ORIGINATED FROM THE BALLOON. THERE WERE NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23233639 ↗
• MalfunctionJun 23, 2025Material 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 VEIN. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305680 ↗
• MalfunctionFeb 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED VESSEL. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING SECOND INFLATION AT BELOW RATED PRESSURE FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE, 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 21393322 ↗
• MalfunctionOct 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC (BSC) DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461762 ↗
• MalfunctionSep 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 15 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267317 ↗
• MalfunctionAug 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 10 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027179 ↗
• MalfunctionOct 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 3 SECONDS, THE TIP PART OF THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994958 ↗
• MalfunctionAug 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS, LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED VERTICALLY IN THE MIDDLE PART. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17660353 ↗
• MalfunctionJul 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 9.0 X 20 X 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT NOMINAL ATMOSPHERES FOR 15 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 POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17359882 ↗
• MalfunctionMay 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED AT THE CENTER OF THE BALLOON. THE DEVICE WAS REMOVED, AND 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 16866000 ↗
• MalfunctionJan 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS COMMON ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 8 ATMOSPHERES FOR 3SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16217692 ↗
• MalfunctionJun 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED AND A PINHOLE WAS NOTED IN THE MIDDLE OF THE BALLOON. 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 AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634388 ↗
• MalfunctionMay 19, 2022Material 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 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437984 ↗
• MalfunctionJan 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 90% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 5 ATMOSPHERES FOR 2 SECONDS, THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13202997 ↗
• MalfunctionJul 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A .9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 8 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215857 ↗
• MalfunctionMar 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC VESSEL. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION AND WAS INITIALLY INFLATED TO 15 ATMOSPHERES FOR 10 SECONDS. HOWEVER, DURING THE SECOND INFLATION AT 15 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554341 ↗
• MalfunctionMar 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VESSEL. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION, 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 STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408992 ↗
• MalfunctionApr 20, 2020Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28MAR2020. IT WAS REPORTED THAT BALLOON LEAK WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, IT WAS NOTICED THAT THE CONTRAST MEDIA WAS LEAKED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978376 ↗
• MalfunctionSep 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 20 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9110430 ↗
• MalfunctionJul 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A 9.0 X 20MM, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR INFLATION. HOWEVER, ON INITIAL INFLATION, THE BALLOON COULD NOT APPLY PRESSURE AND RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8830419 ↗
• MalfunctionMar 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 9.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, UPON INITIAL INFLATION AT 8 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 9/40 MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8400358 ↗