MUSTANG™ H74939171070470Recalls & reported problems

Summary

The FDA's MAUDE database contains 265 adverse event reports that list this exact device (DI 08714729793342), received between Aug 30, 2018 and Sep 21, 2026 — classified as 7 injuries, 258 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (244 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 25 most recent of 265 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Rupture

  It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified external Iliac artery. A 7.0 x 40, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon ruptured and in a pinhole form at the middle part upon first inflation at 8 atmospheres for 3 seconds. The device was removed without any problem using the normal method, and the procedure was completed with a different device. There were no patient complications as a result of this event, and the patient was in good condition post-procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839487 ↗
• MalfunctionAug 11, 2026Inflation Problem; Material Puncture/Hole; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209679 ↗
• MalfunctionJul 20, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25884333 ↗
• MalfunctionJul 20, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25884326 ↗
• MalfunctionJul 20, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25874056 ↗
• MalfunctionJul 7, 2026Fluid/Blood Leak

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS HARDLY CALCIFIED ARTERIOVENOUS FISTULA. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE INFLATION AT NOMINAL ATMOSPHERES, A LEAKAGE OF RADIOCONTRAST WAS DETECTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25736756 ↗
• MalfunctionJun 17, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SHUNT. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR NOMINAL BURST PRESSURE (NBP). THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 25536386 ↗
• MalfunctionMay 11, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RADIAL ARTERY. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE SECOND INFLATION AT 10 POUNDS PER SQUARE INCH (PSI) TO RATE PSI FOR 3-5 SECONDS, THE BALLOON RUPTURED. AFTER DEFLATING THE BALLOON, IT WAS REMOVED THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145509 ↗
• MalfunctionApr 13, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ANASTOMOSIS. A 7.0 X 40, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24855859 ↗
• MalfunctionApr 7, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON FEMORAL ARTERY. A 7.0 X 40, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 20 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798258 ↗
• MalfunctionApr 2, 2026Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, DURING THE DILATION PROCESS USING AN INFLATOR, THE BALLOON RUPTURED, RESULTING IN LEAKAGE OF CONTRAST MEDIUM. THE BALLOON WAS SUBSEQUENTLY REMOVED, AND AN ADDITIONAL ATTEMPT AT DILATION WITH THE SAME DEVICE WAS UNSUCCESSFUL, AS BALLOON INFLATION COULD NOT BE ACHIEVED. IT WAS DETERMINED THAT THE PROCEDURE COULD NOT BE COMPLETED USING THE INITIAL DEVICE. THE DEVICE WAS THEN REPLACED WITH ANOTHER OF THE SAME SPECIFICATION, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24770223 ↗
• MalfunctionMar 2, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILD CALCIFIED COMMON ILIAC ARTERY. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FOURTH INFLATION AT 13 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 24482589 ↗
• MalfunctionFeb 25, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE BRACHIAL VEIN. A 7.0 X 40, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT RATED BURST PRESSURE FOR A FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24448671 ↗
• MalfunctionFeb 9, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT RATED BURST PRESSURE, THE BALLOON RUPTURED. THE DEVICE COULD BE NORMALLY REMOVED, AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293592 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak; Inflation Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 5JAN2026. IT WAS REPORTED THAT BALLOON FAILURE TO INFLATE OCCURRED. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON CONTINUOUS CONTRAST MEDIUM LEAKAGE WAS OBSERVED AND THE BALLOON FAILED TO EXPAND. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. HOWEVER, COMPLETE DEVICE ANALYSIS REVEALED, A LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254036 ↗
• MalfunctionJan 9, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE PATIENT HAD STENOSIS OF THE ARTIFICIAL ARTERIOVENOUS FISTULA AND WAS TAKEN TO THE OPERATING ROOM FOR A FISTULA BALLOON ANGIOPLASTY. A 7.0 X 40, 75CM MUSTANG WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE THIRD REPLACEMENT BALLOON, WHICH RESULTED IN AN EXTENDED PROCEDURE TIME. POSTOPERATIVE INSPECTION OF THE BALLOON WALL REVEALED A VISIBLE TEAR, BUT NO SIGNIFICANT FRAGMENTATION WAS OBSERVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020364 ↗
• MalfunctionDec 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90 STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE FIRST INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 23860300 ↗
• MalfunctionDec 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED AT THE CENTER OF THE BALLOON. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT ADVERSE EVENT WAS REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846996 ↗
• MalfunctionDec 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 7.0 X 40, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 10 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT ADVERSE EVENT WAS REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823981 ↗
• MalfunctionDec 15, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE PROPERLY. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. THE VESSEL EXHIBITED MORE THAN MODERATE TORTUOSITY AND MILD CALCIFICATION. A 7.0 X 40 MM, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO NOMINAL PRESSURE AND HELD FOR APPROXIMATELY 30 SECONDS. HOWEVER, THE BALLOON DID NOT DEFLATE PROPERLY. THERE WAS NO ISSUE REMOVING THE DEVICE EVEN THOUGH IT DID NOT DEFLATE PROPERLY. THE BALLOON COULD NOT BE REUSED TO RE-CROSS THE LESION, SO 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 23810890 ↗
• MalfunctionDec 11, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20NOV2025. IT WAS REPORTED BALLOON FAILURE TO INFLATE AND LEAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA (AVF). A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT CONTRAST AGENT KEPT LEAKING, AND THE BALLOON DID NOT EXPAND AT ALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780822 ↗
• MalfunctionDec 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY (EIA). A 7.0 X 40,75CM MUSTANG BALLOON CATHETER WAS ADVANCE FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 5SECOND. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704445 ↗
• MalfunctionNov 25, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT STUCK ON WIRE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RADIAL VEIN. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON STUCK ON THE GUIDEWIRE AND COULD NOT BE REMOVED. THE BALLOON WAS EXTRACTED TOGETHER WITH THE GUIDEWIRE. SEPARATION OF THE TWO COMPONENTS OUTSIDE THE BODY WAS DIFFICULT. NEW DEVICES WERE USED FOR BOTH, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647649 ↗
• MalfunctionNov 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 10SECOND. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607218 ↗
• MalfunctionNov 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL OF ILIAC. A 7.0 X 40, 75CM MUSTANG WAS SELECTED FOR USE IN AN ENDOVASCULAR TREATMENT. DURING THE FIRST INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450013 ↗