MUSTANG™ H74939171050670Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729793977), received between Jun 25, 2021 and Jun 23, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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.

• MalfunctionJun 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 5.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR ARTERIOVENOUS FISTULAPLASTY PROCEDURE. HOWEVER, THE BALLOON BURST AT THE RATED BURST PRESSURE AFTER 1 MINUTE DURING THE FIRST INFLATION. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307858 ↗
• MalfunctionOct 20, 2022Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT HOLE ON THE SHAFT OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERY OF THE UPPER EXTREMITY. A 5.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS INSERTED INTO THE LESION, THE ENCORE COULD NOT DILATE THE BALLOON. IT WAS FOUND THAT THE SHAFT OF THE BALLOON HAS A PINHOLE WHICH CONTRIBUTED TO LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15644556 ↗
• MalfunctionAug 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 5.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE DISTAL TIP OF THE DEVICE DETACHED WHILE FLUSHING WITH SALINE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222749 ↗
• MalfunctionJul 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A RADIAL ARTERIOVENOUS FISTULA. A 5.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. 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 15130517 ↗
• MalfunctionMay 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE NOMINAL PRESSURE. 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 14269790 ↗
• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT ARTERIOVENOUS FISTULA (AVF) ANGIOPLASTY. A 5.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION AND WAS INITIALLY INFLATED AT 10 ATMOSPHERES. HOWEVER, DURING THE SECOND INFLATION AT 23 ATMOSPHERES, THE BALLOON BURST. THE DEVICE WAS REMOVED AND 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 13691785 ↗
• MalfunctionJun 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 5.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING SECOND INFLATION, IT WAS NOTED THAT THE BALLOON BURST AT 10 ATMOSPHERES FOR 30 SECONDS DURATION TIME WHILE BLOWING IT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS SEVERELY TORTUOUS AND SEVERELY CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12088747 ↗
• MalfunctionJun 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 5.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 9 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12072140 ↗