MUSTANG™ H74939171050210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729793618), received between Dec 6, 2018 and Jun 9, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING A CROSSOVER APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC VEIN. A 5.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640949 ↗
• MalfunctionMay 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 8 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14525319 ↗
• MalfunctionMay 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 5.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING OF THE BALLOON, IT WAS NOTICED THAT THE DISTAL TIP OF THE BALLOON DELIVERY SYSTEM WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11785860 ↗
• MalfunctionDec 6, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED TO BE STUCK IN THE WIRE. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE AND BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8139122 ↗