MUSTANG™ H74939171100410Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08714729793823), received between Dec 5, 2018 and Sep 7, 2026 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (22 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2026Material Rupture

  It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the subclavian artery. A 10.0 x 40, 135cm Mustang balloon was advanced for dilation. However, it was noted that the balloon ruptured when the pressure reached 12 atmospheres during the procedure. The procedure was completed with another of the same device. There were no patient complications as a result of this event, and the patient was stable post-procedure.It was further reported that the target lesion was moderately tortuous and moderately calcified. The balloon completely removed from the patient's body via guiding sheath after air was removed from the balloon.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50644953 ↗
• MalfunctionMay 13, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY (CIA). A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 2 SECONDS. 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 25160553 ↗
• MalfunctionFeb 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC VEIN. A 10.0 X 40, 135CM MUSTANG BALL;OON CATHETER WAS ADVANCE FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367868 ↗
• MalfunctionDec 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC VEIN. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 15 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904356 ↗
• MalfunctionSep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC ARTERY. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED IN A PINHOLE FORM AT DISTAL NEAR THE TIP UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 5 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20303893 ↗
• MalfunctionJun 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, ON THE SECOND INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED VERTICALLY. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND NO DAMAGE WAS NOTED. A DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19590131 ↗
• MalfunctionJun 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 3 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459418 ↗
• MalfunctionJun 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION, THE PRESSURE COULD NO LONGER BE INCREASED AFTER REACHING 4 ATMOSPHERES (ATM), DESPITE THAT THE RATED BURST PRESSURE WAS 20 ATM. WHEN THE BALLOON WAS WITHDRAWN, UPON PRESSURE DECREASING, IT WAS NOTED THAT THE CONTRAST IN THE PUMP WAS MIXED WITH BLOOD, INDICATING THAT THE BALLOON WAS LEAKING. AFTER REMOVAL FROM THE PATIENT'S BODY, LIQUID WAS INJECTED INTO THE BALLOON WITH A SYRINGE, AND IT WAS NOTED THAT THERE WAS A PINHOLE ON THE BALLOON BODY. THE PROCEDURE WAS COMPLETED WITH A NEW 10X40 MUSTANG BALLOON FOLLOWED BY A 10X37 BSC LD STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218374 ↗
• MalfunctionOct 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VEIN. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION UNDER NORMAL WORKING PRESSURE, THE BALLOON RUPTURED. 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 15601410 ↗
• MalfunctionSep 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING SECOND INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURY REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348400 ↗
• MalfunctionFeb 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUBCLAVIAN ARTERY. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE THIRD INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13574593 ↗
• MalfunctionFeb 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION BEFORE REACHING THE RATED BURST PRESSURE, 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 13519153 ↗
• InjuryDec 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS USED TO DILATE MULTIPLE AREAS WITHIN THE ANATOMY IN A VENOUS ANGIOPLASTY PROCEDURE. AFTER AN UNKNOWN MANUFACTURER'S NITINOL STENT WAS IMPLANTED, THE SAME 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, ON THE THIRD INFLATION, THE BALLOON BURST . THE 10.0 X 40, 135CM MUSTANG BALLOON CATHETER COULD NOT BE COMPLETELY REMOVED FROM THE PATIENT WHEN DEFLATED. THE PHYSICIAN PERFORMED PERIPHERAL AND PULMONARY AORTOGRAPHY BUT FAILED TO LOCATE THE DEVICE FRAGMENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER POST DILATATION BEING PERFORMED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13011882 ↗
• MalfunctionDec 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION IN A LESS WORKING PRESSURE FEW SECONDS, THE BALLOON WAS NOT FULLY DEPLOYED AND WAS BURST DURING THE PROCESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12994485 ↗
• MalfunctionNov 2, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15OCT2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 10X2CM TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, A LEAK WAS NOTICED IN THE DISTAL PART OF THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737193 ↗
• MalfunctionSep 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT BELOW RATED BURST PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12539362 ↗
• MalfunctionSep 22, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE FOR TREATING OBSTRUCTION CAUSED BY SUBGLOTTIC CAVITY STENOSIS, THE BALLOON FAILED TO CROSS THE VESSEL SHEATH. REPEATED ATTEMPTS WERE MADE BUT FAILED TO TAKE THE DEVICE OUT FROM THE PATIENT. EVENTUALLY, THE DEVICE WAS SIMPLY PULLED OUT AND 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 12517184 ↗
• MalfunctionDec 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT SUBCLAVIAN VEIN. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING INITIAL INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURE. THE DEVICE WAS REMOVED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10936924 ↗
• MalfunctionNov 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS 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 10863920 ↗
• MalfunctionMar 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ILIAC ARTERY. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898382 ↗
• MalfunctionFeb 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS 40.0 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 10.0 MM. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION AND A 10ML SYRINGE WAS USED FOR INFLATING THE BALLOON WITH RATIO OF 50:50% SALINE AND CONTRAST. HOWEVER, DURING INJECTION OF THE SOLUTION FOR INFLATION, THE BALLOON RUPTURED INSIDE THE VESSEL AND THE CONTRAST WAS SPILLED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A 10X40 MUSTANG BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747706 ↗
• MalfunctionFeb 20, 2020Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING BALLOON INFLATION, CONTRAST SOLUTION LEAKED OUTSIDE OF THE CATHETER FROM WHAT APPEARED TO BE A PINHOLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE 30-40% STENOSED TARGET LESION WAS LOCATED IN THE ILIAC ZONE AND THAT THERE WAS NO SIGNIFICANT CALCIFICATION OR TORTUOSITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9733749 ↗
• MalfunctionFeb 6, 2020Leak/Splash; Leak/Splash

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 20JAN2020. IT WAS REPORTED THAT A LEAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. DURING INFLATION OF A 10.0 X 40, 135CM MUSTANG BALLOON, THE BALLOON WAS PIERCED AND A LEAK OF CONTRAST WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678281 ↗
• MalfunctionJan 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE ARM. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9611138 ↗
• MalfunctionDec 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED ILIAC ARTERY. A 10.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION WITHIN SPECIFIED PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WA STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8135404 ↗