MUSTANG™ H74939171060810Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729793793), received between Oct 17, 2018 and Sep 24, 2026 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889969 ↗
• MalfunctionJul 7, 2026Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. THE TARGET LESION WAS LOCATED WITHIN A NON-TORTUOUS, NON-CALCIFIED HEPATIC VESSEL. DURING THE PROCEDURE, A 5.0 MM X 80 MM, 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED TO THE TARGET SITE FOR VESSEL DILATATION. DURING INFLATION, THE BALLOON RUPTURED WHEN THE PRESSURE REACHED 14 ATMOSPHERES. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. THE EVENT WAS NOT ATTRIBUTED TO CHALLENGING PATIENT ANATOMY, UNDERLYING COMORBIDITIES, DISEASE PROGRESSION, OR OTHER PROCEDURAL FACTORS. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT, AND THE PATIENT REMAINED STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25729347 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED REQUIRING ADDITIONAL INTERVENTION. ON (B)(6) 2026, THE PATIENT UNDERWENT A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE DURING WHICH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATION CATHETER WAS USED IN THE STANDARD MANNER. THE PATIENT ANATOMY WAS NOT CHALLENGING, AND THERE WAS NO NARROWING LESION. AN AMPLATZ ULTRA-HARD GUIDEWIRE WAS ADVANCED TO THE DISTAL SPLENIC VEIN, AND A 6.0 X 80 MM, 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED TO DILATE THE PUNCTURE TRACT AND EXPAND THE LIVER PARENCHYMA. FOLLOWING DILATION, THE BALLOON FAILED TO DEFLATE, AND THE BALLOON PRESSURE COULD NOT BE REDUCED, RESULTING IN A DELAY IN THE PROCEDURE. THE SURGEON SUSPECTED THAT THE ASSISTANT MAY HAVE INADVERTENTLY MIXED MEDICAL GLUE INTO THE CONTRAST AGENT, CAUSING OCCLUSION OF THE BALLOON LUMEN AND PREVENTING NORMAL BALLOON DEFLATION AND RETRACTION. PROLONGED INABILITY TO DEFLATE THE BALLOON POSED A POTENTIAL RISK TO THE PATIENT'S BLOOD VESSELS. TO MITIGATE THIS RISK, THE PHYSICIAN PROMPTLY PUNCTURED THE BALLOON, ALLOWING SUCCESSFUL DEFLATION AND RETRIEVAL OF THE DEVICE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579163 ↗
• MalfunctionNov 7, 2025Fluid/Blood Leak; Inflation Problem; Leak/Splash; Material Rupture; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Inflation Problem; Leak/Splash; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED AT THE STENOSIS OF THE MIDDLE SEGMENT OF THE LEFT SUPERFICIAL FEMORAL ARTERY. A 6.0 X 80, 135CM MUSTANG CATHETER BALLOON WAS USED FOR DILATION. DURING THE PROCEDURE, UPON INFLATION, IT WAS NOTED THAT THE BALLOON WAS IRREGULAR IN SHAPE AND FAILED TO ACHIEVE THE EXPECTED EXPANSION EFFECT AND THE CONTRAST MEDIUM WAS SEEN LEAKING FROM THE DAMAGED PART OF THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FOR THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501332 ↗
• MalfunctionMay 16, 2025Inflation Problem; Inflation Problem

  REPORTABLE BSED ON THE DEVICE ANALYSIS COMPLETED ON 24APR2025. IT WAS REPORTED THAT THE TIP WAS NOT FULLY INFLATED. THE TARGET LESION WAS A STENOSED SEGMENT LOCATED FROM THE LEFT SUPERFICIAL FEMORAL ARTERY TO THE POPLITEAL ARTERY. A MUSTANG BALLOON CATHETER 6.0 MM X 80 MM, 135 CM LENGTH WAS SELECTED FOR GRADUAL DILATATION. HOWEVER, A MUSTANG BALLOON 4.0 MM X 100 MM WAS ALSO USED FOR PRE-DILATATION. DURING THE PROCEDURE, WHEN THE BALLOON REACHED THE TARGET LESION AND INFLATION PRESSURE REACHED 12 ATMOSPHERES, IT WAS NOTED THAT THE BALLOON TIP DID NOT FULLY INFLATE. 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. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034810 ↗
• MalfunctionNov 23, 2024Leak/Splash; Difficult to Advance; Leak/Splash; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11NOV2024. IT WAS REPORTED THAT DIFFICULT TRACKING AND BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING PREPARATION, THE BALLOON WAS FLUSHED, AND IT WAS NOTED THAT IT COULD NOT CROSS OVER THE V-18 WIRE. THE BALLOON WAS INFLATED ONCE AT 10 ATMOSPHERES. UPON WITHDRAWING, THE BALLOON WAS NOTED TO BE LEAKING LIQUID. NO PINHOLE WAS NOTED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20766870 ↗
• MalfunctionMar 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH ATHEROSCLEROTIC OBLITERANS. THE TARGET LESION WAS LOCATED IN LOWER EXTREMITY ARTERY. A 6.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE AT 20 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT WAS STABLE FOLLOWING PROCEDURE. IT WAS FURTHER REPORTED THAT TARGET LESION WAS LOCATED IN NON-TORTUOUS AND LOCALLY SEVERE CALCIFIED LOWER EXTREMITY ARTERY. THE BALLOON INFLATED ONCE AND RUPTURED AT 20 ATM IN 8-10 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633106 ↗
• MalfunctionOct 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS FISTULA. A 6.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 20 ATMOSPHERES FOR 2 MINUTES, 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 CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696004 ↗
• MalfunctionMar 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776508 ↗
• MalfunctionSep 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A SHUNT. A 6.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. ANOTHER 6.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED BUT IT ALSO RUPTURED DURING INFLATION AT 18 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS ABOUT 30% STENOSED AND WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. BOTH DEVICES WERE NOT INFLATED TO THE NOMINAL BAR AT ABOUT 5 SECONDS BEFORE IT RUPTURED. BOTH DEVICES WERE COMPLETELY REMOVED AND WAS REMOVED DIRECTLY FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425667 ↗
• MalfunctionSep 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A SHUNT. A 6.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. ANOTHER 6.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED BUT IT ALSO RUPTURED DURING INFLATION AT 18 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS ABOUT 30% STENOSED AND WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. BOTH DEVICES WERE NOT INFLATED TO THE NOMINAL BAR AT ABOUT 5 SECONDS BEFORE IT RUPTURED. BOTH DEVICES WERE COMPLETELY REMOVED AND WAS REMOVED DIRECTLY FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425663 ↗
• MalfunctionFeb 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION BUT AFTER FILLED WITH AGENT CONTRAST, THE BALLOON COULD NOT FULLY INFLATE. HOWEVER, WHEN THE BALLOON WAS REMOVED AND FLUSHED WITH LIQUID, IT WAS LEAKING LIQUID AND PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377051 ↗
• InjuryApr 26, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT BALLOON RUPTURE AND DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED VESSEL OF THE ARM. FOLLOWING PRE-DILATION WITH A NON-BSC BALLOON CATHETER, A 6.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE THIRD INFLATION AT 24 ATMOSPHERES IN LESS THAN ONE MINUTE, THE BALLOON RUPTURED. THE BALLOON WAS DETACHED AND WAS ATTEMPTED TO BE RETRIEVED BUT FAILED. A NON-BSC STENT WAS THEN DEPLOYED TO KEEP THE FRAGMENT ON THE VASCULAR WALL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8555697 ↗
• MalfunctionJan 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND HEAVY CALCIFIED ILIAC ARTERY. THREE MUSTANG BALLOON CATHETERS SIZES, 6.0 X 60, 135CM, 6.0 X 80, 135CM AND 8.0 X 40, 75CM WERE ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOONS WAS INFLATED BY NOMINAL PRESSURE, THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8246946 ↗
• MalfunctionOct 17, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN A VEIN. A 6X80X135MM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 15CC, IT WAS OBSERVED THAT THE PRESSURE WENT DOWN TO 5 CC. THE DEVICE WAS REMOVED AND THE BALLOON WAS FOUND LEAKING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7973671 ↗