MUSTANG™ H74939171100870Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729794332), received between Apr 30, 2020 and Aug 7, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RADIAL ARTERY. A 10.0 X 80, 75CM MUSTANG BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE SECOND INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED INSIDE THE PATIENT'S BODY. THE DEVICE WAS REMOVED, 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 22737351 ↗
• MalfunctionMar 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS RUPTURED OCCURRED. A 10.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED JUST PRIOR TO THE INTENDED PRESSURE BEING ACHIEVED. THE DEVICE WAS SUBSEQUENTLY REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21589916 ↗
• MalfunctionMar 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 10.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST WHILE BLOWING IT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997306 ↗
• MalfunctionNov 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET ANATOMY WAS LOCATED IN THE BRACHIOCEPHALIC LESION. A 10.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON BURST BEFORE REACHING THE OPERATING PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18202766 ↗
• MalfunctionAug 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 10.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MUSTANG BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17556790 ↗
• MalfunctionApr 12, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. A 10.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION IN A HEAVILY CALCIFIED VESSEL. HOWEVER, THE BALLOON FAILED TO DEFLATE AFTER IT WAS BEING INFLATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728442 ↗
• InjuryDec 20, 2021Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility; Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT BALLOON RUPTURE AND TIP DETACHMENT OCCURRED. THE GREATER THAN 50% STENOSED TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS LOCATED IN THE CEPHALIC VEIN. A 10.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED TO DILATE A PREVIOUSLY PLACED STENT. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AND THE TIP OF THE BALLOON BROKE OFF INSIDE THE PATIENT. IT WAS SUSPECTED THAT THE BALLOON TIP WAS CAUGHT ON THE END OF A STENT STRUT. THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON CATHETER AND SHEATH BUT COULDN'T GET THE NON-BSC GUIDEWIRE AND THE BALLOON TIP. THE PHYSICIAN SUTURED A PERCHIK BUTTON OVER THE ACCESS SITE AND THE WIRE WAS SECURED TO THE PATIENT'S ARM. THE PATIENT UNDERWENT SURGERY TO REMOVE THE WIRE AND THE BALLOON TIP SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044578 ↗
• MalfunctionJul 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON PINHOLE WAS NOTED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A FISTULA, CENTRAL LINE FOR HEMODIALYSIS TREATMENT. A 10.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE PHYSICIAN STARTED TO INFLATE THE BALLOON WITH THE INDEFLATOR, THE BALLOON COULD NOT INFLATE WELL DUE TO A PINHOLE AND THE PRESSURE OF THE BALLOON GOT ONLY UP TO 2 ATMOSPHERES. THE PHYSICIAN REMOVED THE BALLOON AND COMPLETED THE PROCEDURE WITH ANOTHER OF 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 12121787 ↗
• MalfunctionMar 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN THE CENTRAL VEIN. A 10.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 75% STENOSED WITH LESS THAN 45 DEGREES BEND, SEVERELY CALCIFIED AND SEVERELY TORTUOUS. THE BALLOON WAS INFLATED ONCE AT 10 ATMOSPHERES FOR 1 SECOND BEFORE IT RUPTURED AND WAS COMPLETELY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556183 ↗
• MalfunctionApr 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CENTRAL VEIN. A 10.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 9 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS NORMAL. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CENTRAL VEIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10012778 ↗