MUSTANG™ H74939171060240Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729793908), received between Oct 24, 2018 and Aug 2, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED UPPER ARM SHUNT BLOOD VESSEL. A 6.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 15149827 ↗
• MalfunctionJun 18, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED, ABOUT 10CM TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VEIN IN THE LEFT FOREARM. AFTER A 5F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER AND A .035 NON-BSC GUIDEWIRE WERE CROSSED THE LESION, A 6.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE SECOND INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND CONTRAST AGENT WAS FOUND TO BE LEAKING. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE AS THE MINIMUM NECESSARY INFLATION WAS OBTAINED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028640 ↗
• MalfunctionApr 29, 2020Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06APR2020. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA IN THE ARM. A 6.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE WAS UNABLE TO INFLATE. BALLOON WAS TOOK OUT OF THE PATIENT'S BODY AND INSPECTED AND A LEAK WAS NOTED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10010689 ↗
• MalfunctionMar 30, 2020Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 6.0 X 20MM, 40CM MUSTANG BALLOON CATHETER WAS USED FOR DILATION; HOWEVER, DURING INFLATION THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897945 ↗
• MalfunctionFeb 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742738 ↗
• MalfunctionJan 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VEIN THE FOREARM. A 6.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9639753 ↗
• MalfunctionNov 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SHUNT IN A VESSEL. A 6.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING 15TH INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE INFLATION WAS ENOUGH TO COMPLETE THE PROCEDURE AND NO PATIENT COMPLICATONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9390442 ↗
• MalfunctionOct 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED FOREARM. A 6.0 X 20, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE THE BALLOON RUPTURED WHEN PRESSURE WAS APPLIED BELOW THE RATED BURST PRESSURE. THE PROCEDURE WAS NOT COMPLETED AS ANOTHER OF THE SAME DEVICE WAS NOT AVAILABLE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8000318 ↗