MUSTANG™ H74939171041510Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729793694), received between Aug 20, 2019 and Sep 21, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Rupture

  It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified limb. A 4.0 x 150, 135cm Mustang balloon catheter was selected for below the knee angioplasty. During the procedure, the balloon ruptured upon first inflation at 24 atmospheres for 2 minutes. The balloon was removed successfully from the patient, and the procedure was completed with a 4x100 Mustang. There were no patient complications as a result of this event, and the patient was stable post-procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835897 ↗
• MalfunctionJan 14, 2026Material Rupture

  IT WAS REPORTED THAT A BALLON RUPTURE OCCURRED. DURING EMBOLIZATION OF A THORACIC AORTIC ANEURYSM, A 4.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS USED FOR DILATATION FOLLOWING PUNCTURE AND FENESTRATION OF THE BRACHIAL ARTERY. HOWEVER, DURING THE INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A 4 X 40 BALLOON. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE STENOSED TARGET LESION, WHICH EXHIBITED 70%, WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED SUBCLAVIAN ARTERY. THE PATIENT'S ANATOMY WAS NOT CONSIDERED DIFFICULT TO MANAGE. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA, AND NO PATIENT-RELATED FACTORS WERE INVOLVED. ADDITIONALLY, NO PROCEDURAL FACTORS WERE FOUND TO HAVE CONTRIBUTED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067334 ↗
• MalfunctionMar 10, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT A RELIEF AND TREATMENT OF SUPERFICIAL FEMORAL ARTERY STENOSIS. A 4.0 X 150, 135CM MUSTANG WAS USED FOR DILATION. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE BALLOON BURST WHILE BEING DILATED WITH PRESSURE USING AN INFLATOR, CAUSING THE CONTRAST MEDIUM TO LEAK OUT. AFTER REMOVING THE DEVICE AND ATTEMPTING DILATION AGAIN, IT WAS CONFIRMED THAT THE CONTRAST MEDIUM HAD LEAKED FROM THE BALLOON. 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 21567039 ↗
• MalfunctionMay 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY OF THE RIGHT LOWER LIMB. A 4.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED WHEN IT WAS PRIMED TO 12 ATMOSPHERES. THE DEVICE WAS REMOVED AND REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED, AND PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247062 ↗
• MalfunctionApr 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6F NON-BOSTON SCIENTIFIC SHEATH WAS USED FOR PUNCTURE AND A V18 GUIDEWIRE WAS CROSSED WITH THE HELP OF ANOTHER NON-BOSTON SCIENTIFIC SUPPORT CATHETER. AFTER THE GUIDEWIRE WAS CROSSED, THE 6F SHEATH WAS REMOVED AND A 3.0 X 150CM MUSTANG BALLOON CATHETER WAS ADVANCED AND DILATED GRADUALLY. SUBSEQUENTLY, AFTER DILATION, THE 3.0 X 150CM BALLOON WAS REMOVED AND A 4.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED. UPON INITIAL INFLATION AT 3-4 ATMOSPHERES FOR 2 SECONDS, IT WAS FOUND THAT THE BALLOON WAS LEAKING LIQUID AND BECAME BROKE. THE DEVICE WAS WITHDRAWN AND REPLACED WITH A NEW BALLOON. THE ANGIOGRAPHY OBSERVES GOOD VESSEL SHAPE AND A 4.0 X 150CM DRUG-BALLOON CATHETER WAS USED FOR ANOTHER DILATION. ANOTHER ANGIOGRAPHY WAS PERFORMED, AND NO VESSEL DISSECTION WAS NOTED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067810 ↗
• MalfunctionJan 4, 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. A 4.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16093067 ↗
• MalfunctionJul 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 4.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT BELOW WORKING PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND 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 15064571 ↗
• MalfunctionJun 24, 2022Deflation Problem; Difficult to Advance; Deflation Problem; Difficult to Advance

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE THERE WERE PROBLEMS NOTICED WITH THE CATHETER AND ITS PROGRESS WHILE ADVANCING. THE DEVICE WAS THEN REMOVED; HOWEVER, THE PHYSICIAN FOUND IT WAS HARD TO RE-ENTER THE LESION AS PROBABLY IT WAS NOT FULLY DEFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14803181 ↗
• MalfunctionJun 18, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 4-5MMX150MM, ECCENTRIC, DE NOVO TARGET LESION WITH APPROXIMATELY 80% STENOSIS AND FIBROUS-LIPIDICA PLAQUE WAS LOCATED IN THE MILDLY CALCIFIED AND NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 4.0 X 150MM, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 14 ATMOSPHERES FOR 2 MINUTES, THE PRESSURE WAS LOST. A PINHOLE AND LEAK WERE NOTED ON THE DISTAL PART OF THE BALLOON AFTER BEING WITHDRAWN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025637 ↗
• MalfunctionJun 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE MILDLY STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT ILIOFEMORAL ARTERY. A 4.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, ON THE THIRD INFLATION AT LESS WORKING PRESSURE, THE BALLOON RUPTURED. 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 11918331 ↗
• MalfunctionDec 29, 2020Material 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 4.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION, THE BALLOON PRESSURE COULD NOT MAINTAIN. IT WAS NOTED THAT THE PRESSURE WAS 4 ATMOSPHERES AND LASTED FOR 5 SECONDS. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11092204 ↗
• MalfunctionDec 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THAT BALLOON HOLE OCCURRED.DURING PREPARATION OF A 4 X 150 X 135 MUSTANG BALLOON CATHETER, A HOLE WAS NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NEW MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9477798 ↗
• MalfunctionAug 20, 2019Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31JUL2019. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION AT 12 ATMOSPHERES FOR 3 SECONDS, THE BALLOON FAILED TO INFLATE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON CIRCUMFERENTIAL TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912923 ↗