MUSTANG™ H74939171051510Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729793434), received between Oct 29, 2018 and Sep 8, 2025 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT THE NOMINAL BURST PRESSURE FOR ABOUT ONE MINUTE. 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 22998569 ↗
• MalfunctionDec 1, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHEETR WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, WHEN THE DEVICE WAS UNPACKED TO REACH THE LESION SITE AND IT WAS FOUND THAT THE CONTRAST MEDIUM OVERFLOWED AND THE PRESSURE WAS UNSTABLE. AFTER WITHDRAWAL, IT WAS FOUND THAT THE BALLOON HAD A SMALL BREACH. THE DEVICE WAS REMOVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20814928 ↗
• MalfunctionNov 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, BALLOON RUPTURED WHEN THE BURSTING PRESSURE WAS NOT REACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80% STENOSED, NON-TORTUOUS AND SEVERELY CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20768074 ↗
• MalfunctionSep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL OF BELOW THE KNEE, NEAR THE POPLITEAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 9 ATMOSPHERES. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME PRODUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300768 ↗
• MalfunctionSep 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INFLATION AT 12 ATMOSPHERES FOR ABOUT 5 SECONDS. THE DEVICE WAS REMOVED ALONG WITH THE GUIDEWIRE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200097 ↗
• MalfunctionMay 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, ON THE FIRST INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM WITH NO DAMAGE FOUND ON THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274342 ↗
• MalfunctionApr 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. A 5.0 X 150, 135CM MUSTANG BALLOON WAS SELECTED FOR USE. HOWEVER, DURING FLUSHING, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011048 ↗
• MalfunctionMar 6, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON WAS USED TO RELIEVE AND TREAT THE LESION STENOSIS IN THE PATIENT. DURING THE PROCESS OF DILATATION, THE BALLOON BURST AND THE CONTRAST AGENT LEAKED OUT. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, AND FURTHER DILATATION WAS ATTEMPTED, BUT IT DID NOT EXPAND, AND THE CONTRAST AGENT LEAKED OUT OF THE BALLOON. THE PROCEDURE WAS COMPLETED NORMALLY BY REPLACING IT WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851154 ↗
• MalfunctionJan 8, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 70% STENOSED, 7MM X 3MM TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INTRODUCTION, THE DEVICE FAILED TO PASS THROUGH A 6FR SHEATH. THE SHEATH AND THE 0.035 260CM ZIPWIRE GUIDEWIRE WERE REPLACED BUT THE DEVICE WAS DIFFICULT TO TRACK OVER THE GUIDEWIRE. DURING THE FIRST INFLATION AT 5 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465676 ↗
• MalfunctionNov 29, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 70% STENOSED, 7MM X 3MM TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INTRODUCTION, THE DEVICE FAILED TO PASS THROUGH A 6FR SHEATH. THE SHEATH AND THE 0.035 260CM ZIPWIRE GUIDEWIRE WERE REPLACED BUT THE DEVICE WAS DIFFICULT TO TRACK OVER THE GUIDEWIRE. DURING THE FIRST INFLATION AT 5 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18232456 ↗
• MalfunctionJul 5, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27-JUN 2023. IT WAS REPORTED THAT A BALLOON LEAK OCCURRED. THE PATIENT UNDERGO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, CONTRAST LEAKAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MUSTANG BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257171 ↗
• InjuryJul 31, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND DEFLATION ISSUE OCCURRED. THE MORE THAN 70% STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON WAS UNABLE TO BE WITHDRAWN DURING THE PROCEDURE. EVENTUALLY, THE PHYSICIAN USED OTHER DEVICE TO DEFLATE THE BALLOON AND THE DEVICE WAS REMOVED IN A DEFLATED STATE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136823 ↗
• InjuryApr 13, 2022Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS LOCATED IN THE LEFT ILIAC ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INTRODUCTION, THE BALLOON WAS DIFFICULT TO ADVANCE. THE BALLOON WAS HOOKED BY THE STENT AND WAS DAMAGED. ADDITIONALLY, THE PHYSICIAN FOUND THE DILATION WAS NOT SUFFICIENT. THE MUSTANG BALLOON WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103099 ↗
• MalfunctionFeb 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441942 ↗
• MalfunctionJan 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIFTH INFLATION AT 15 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13368735 ↗
• MalfunctionSep 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED IN A FORM OF A VERTICAL CRACK. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544088 ↗
• MalfunctionJun 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS SUPERFICIAL FEMORAL ARTERY OF THE LOWER LIMBS. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE CONTRAST AGENT WAS FOUND TO BE LEAKING OUT OF THE BALLOON AFTER IT WAS BEING INFLATED AT 10 ATMOSPHERES. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT AND PINHOLE WAS NOTED ON THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH 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 12083506 ↗
• MalfunctionFeb 17, 2021Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 22 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339970 ↗
• MalfunctionMar 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 20 ATMOSPHERES FOR 1 MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9846833 ↗
• MalfunctionDec 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE WAS BEING PERFORMED. THE 10% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. AFTER DEPLOYING AN ELUVIA STENT, THIS 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS SELECTED, WHEN PREPARING FOR INFLATION ANGIOGRAPHY REVEALED CONTRAST AGENT COMING OUT FROM THE DEVICE. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THEY FOUND THAT THE BALLOON HAD BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453517 ↗
• MalfunctionApr 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 150, 135CM BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562647 ↗
• MalfunctionOct 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE HIGHLY CALCIFIED TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL ARTERY. A 5.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION BEFORE THE NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 6.0 X 200, 135CM MUSTANG BALLOON WAS ADVANCED AND BEFORE NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015797 ↗