MUSTANG™ H74939171071270Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729794424), received between Dec 7, 2018 and Dec 19, 2023 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE TARGET LESION LOCATED IN AN ARTERIOVENOUS FISTULA. A 7.0 X 120, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357343 ↗
• MalfunctionSep 21, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE AND CATHETER SHAFT BREAK OCCURRED. A 7.0 X 120, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. AFTER AN UNKNOWN NUMBER OF INFLATIONS, THE BALLOON BURST. THE DEVICE WAS REMOVED FROM THE PATIENT, AND UPON RETRIEVAL, THE CATHETER SHAFT FRACTURED DISTAL TO THE BALLOON. THE DETACHED PORTION WAS REMOVED BY REMOVING THE ENTIRE GUIDEWIRE SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT PRIOR TO INSERTION OF THE MUSTANG BALLOON, THE LESION WAS PRE-DILATED USING AN UNKNOWN 4-5MM BALLOON. THE MUSTANG BALLOON WAS INFLATED TO APPROXIMATELY 10-14ATM PRIOR TO BURSTING. ADDITIONALLY, APPROXIMATELY 35CM OF THE CATHETER SHAFT FRACTURED WITHIN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17793595 ↗
• MalfunctionJun 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 7.0 X 120, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION FOR MORE THAN 3 TIMES, 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 17091595 ↗
• MalfunctionJul 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS ARTERIOVENOUS SHUNT. A 7.0 X 120, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 3 BAR, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14939740 ↗
• MalfunctionApr 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 7.0 X 120, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218379 ↗
• MalfunctionMay 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SHUNT. A 7.0 X 120, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS INFLATED BELOW THE MAXIMUM RATED BURST PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING INFLATION AT 2 ATMOSPHERES FOR 5 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759366 ↗
• MalfunctionDec 7, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SHUNT IN THE BRACHIOCEPHALIC ARTERY. A 7.0 X 120, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR INSUFFLATION. HOWEVER, AFTER INFLATION, IT WAS NOTED THAT THE BALLOON RUPTURED. THE LESION WAS INSUFFLATED ENOUGH TO COMPLETE THE PROCEDURE WITH THIS DEVICE. NO PATIENT COMPLICATIONS NOR SERIOUS INJURIES WERE NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8142464 ↗