MUSTANG™ H74939171080210Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729793847), received between Jun 15, 2020 and Jun 10, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. AN 8.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT THE NOMINAL BURST PRESSURE FOR 10 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 22174993 ↗
• MalfunctionFeb 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH LOWER EXTREMITY ARTERIAL DISEASE AND UNDERWENT ENDOVASCULAR THERAPY. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. AN 8.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442411 ↗
• InjuryMay 23, 2022Break; Fracture; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Break; Fracture; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT BALLOON RUPTURE, BALLOON DETACHMENT AND LOOSE RADIOPAQUE (RO) MARKER BAND OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED FISTULA OF THE LEFT ARM. A 8.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING SECOND INFLATION, THE BALLOON RUPTURED. WHEN THE DEVICE WAS REMOVED, THE SHAFT BROKE 10MM FROM THE HUB AND THE BALLOON BROKE OFF FROM THE SHAFT. THE RO MARKERS CAME OFF AND WERE ON THE WIRE. THE PHYSICIAN TRIED TO REMOVED THE DETACHED BALLOON WITH A SNARE BUT WAS UNSUCCESSFUL. A NON-BOSTON SCIENTIFIC DEVICE WAS DEPLOYED TO SECURE THE BALLOON PIECES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. A FOLLOW-UP WITH THE PATIENT WAS CONDUCTED AND THE FISTULA WAS WORKING FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14476558 ↗
• MalfunctionAug 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 8.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INITIALLY INFLATED AT 10 ATMOSPHERES FOR 30 SECONDS. HOWEVER, DURING SECOND INFLATION AT 16 ATMOSPHERES FOR 30 SECONDS, 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 12295335 ↗
• MalfunctionJun 15, 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 RIGHT COMMON ILIAC ARTERY. A 6F NON-BSC INTRODUCER SHEATH WAS INSERTED. AFTER A NON-BSC GUIDEWIRE CROSSED THE LESION, PRE-DILATATION WAS PERFORMED WITH A 5.00X20MM STERLING BALLOON CATHETER AT 14 ATMOSPHERES. AFTER THE 8MMX27MM EXPRESS LD STENT WAS PLACED, POST DILATATION WAS PERFORMED WITH A 7.0MMX20MMX135CM STERLING BALLOON CATHETER. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND IT WAS REPLACED WITH A 8.0 X 20, 135CM MUSTANG BALLOON CATHETER. HOWEVER, THE BALLOON ALSO RUPTURED IN THE FIRST INFLATION AFTER BEING INFLATED AT 10 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 8MMX4CM MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10155252 ↗