MUSTANG™ H74939171120610Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729795018), received between Aug 17, 2017 and Apr 16, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. 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. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 85% STENOSED, MILDLY TORTUOUS AND MODERATELY CALCIFIED. THE BALLOON RUPTURED UPON SECOND INFLATION FOR 8 SECONDS. THE DEVICE WAS REMOVED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21851958 ↗
• MalfunctionOct 19, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY WAS ENCOUNTERED. ANGIOPLASTY WAS BEING PERFORMED. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED LEFT ILIAC VEIN. A 12.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED AND INFLATED AT 8 ATMOSPHERES FOR 1 MINUTE. HOWEVER, THE VACUUM WAS HELD AND DURING REMOVAL OF THE DEVICE, A RESISTANCE WAS ENCOUNTERED, AND THE BALLOON DOES NOT PASS THROUGH THE INTRODUCER SYSTEM; THEREFORE, THE BALLOON WAS REMOVED COMPLETELY INTACT FROM THE PATIENT IN FULLY DEFLATED STATE WITH THE ENTIRE INTRODUCER SYSTEM. IT WAS THEN OBSERVED THAT THE WINGS OF THE BALLOON WERE BENT. A SECOND ANGIOPLASTY WAS THEN BEING PERFORMED AT THE SAME SITE USING ANOTHER OF THE SAME DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967591 ↗
• MalfunctionJul 8, 2022Difficult to Remove; Device Contamination with Chemical or Other Material; Difficult to Remove; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AND A FOREIGN MATERIAL WAS FOUND ON THE DEVICE. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. THE PHYSICIAN PUNCTURED THE LEFT FEMORAL VEIN AND PLACED 10F VASCULAR SHEATH. AFTER A 260CM HYDROPHILIC GUIDEWIRE CROSSED THE INFERIOR VENA CAVA, THE PHYSICIAN THEN ADVANCED A CATHETER AND REPLACED WITH A STIFF HYDROPHILIC GUIDEWIRE. A 12.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. WHEN THE PHYSICIAN INFLATED THE BALLOON, THE BALLOON WAS SEEN INFLATED UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA), HOWEVER, CONTRAST AGENT COULD NOT BE FILLED INTO THE BALLOON. THE BALLOON WAS INFLATED AT 14 ATMOSPHERES, BUT THE BALLOON WAS NOT SEEN TO INFLATE UNDER DSA. THE PHYSICIAN SLIGHTLY BENT THE BALLOON DELIVERY SHAFT AND IT WAS FELT THERE WAS FOREIGN BODY IN THE DELIVERY SHAFT. THE BALLOON COULD NOT BE FILLED WITH CONTRAST AGENT, AND THE PRESSURE COULD NOT RELEASE AS WELL. THE BALLOON COULD NOT BE REMOVED FROM THE PATIENT. THE PHYSICIAN CUT THE BALLOON DELIVERY SHAFT, THE PRESSURE RELEASED, BUT THE CONTRAST AGENT COULD NOT FLOW OUT FROM THE BALLOON. THE PHYSICIAN GAVE PRESSURE TO THE END OF THE CUT DELIVERY SHAFT THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959474 ↗
• MalfunctionJul 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BALLOON HAD A PINHOLE. THE 60% STENOSED, TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MILDLY CALCIFIED ILIAC VEIN. A 12.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS POSITIONED WHERE IT WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, A CONTRAST MEDIUM LEAK WAS OBSERVED AT THE PROXIMAL END OF THE BALLOON. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY AND THE LEAK WAS CONFIRMED. THE PROCEDURE WAS COMPLETED WITH A NEW 12.0X60X135CM MUSTANG BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12143531 ↗
• MalfunctionSep 11, 2020Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19AUG2020. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION, BUT THE BALLOON COULD NOT INFLATE. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522632 ↗
• MalfunctionMay 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL VEIN. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 12.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION, HOWEVER, THE BALLOON DID NOT INFLATE WHEN IT REACHES 4 TO 6 ATMOSPHERES (ATM). THE PRESSURE WAS AND THE DEVICE REMOVED. WHEN THE PHYSICAN TRIED TO INFLATE THE BALLOON AT 6 ATM OUTSIDE THE PATIENT, LIQUID LEAKED AT THE CONNECTION PART BETWEEN THE BALLOON AND THE MARKER AND A PINHOLE WAS NOTED ON THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080018 ↗
• MalfunctionDec 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED SUBCLAVIAN VEIN. A 12.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED AT NOMINAL ATMOSPHERIC PRESSURE. THE PROCEDURE WAS COMPLETED WITH A 12X80 MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9462294 ↗
• MalfunctionDec 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CENTRAL VEIN. A 12.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION UNDER NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440819 ↗
• MalfunctionSep 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON TEAR OCCURRED. THE TARGET LOCATION WAS LOCATED IN A RIGHT LOWER EXTREMITY VEIN. A 12.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THERE WAS NO RESISTANCE FELT ON THE INFLATION DEVICE WHEN THEY WENT TO DEPLOY THE BALLOON. THE PHYSICIAN THEN PULLED NEGATIVE, AND THE INFLATION DEVICE FILLED WITH BLOOD. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. UPON INFLATION ON THE TABLE, THE BALLOON LEAKED CONTRAST AND COULD NOT EVEN HOLD UP TO 1 ATMOSPHERE OF PRESSURE. A TEAR WAS NOTED ON THE BALLOON AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9079019 ↗
• MalfunctionSep 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERIOR VENA CAVA. A 12.0 X 60, 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9016134 ↗
• MalfunctionDec 18, 2018Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-DEC-2018. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. A 12.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, FOLLOWING DILATATION, NO IMAGE WAS SHOWN. THE DEVICE WAS WITHDRAWN AND IT WAS FOUND THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE. THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. BLOOD WAS IDENTIFIED WITHIN THE BALLOON AND INFLATION LUMEN WHICH IS EVIDENCE OF A DEVICE LEAK. THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN LIQUID WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE LOCATED APPROXIMATELY 14MM PROXIMAL OF THE PROXIMAL MARKERBAND. AN EXAMINATION OF THE BALLOON MATERIAL AND PROXIMAL MARKERBAND IDENTIFIED NO ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THIS COMPLAINT. THE RATED BURST PRESSURE FOR THIS DEVICE IS 14 ATMOSPHERES. A VISUAL AND MICR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8174248 ↗
• MalfunctionAug 17, 2017Material Rupture; Material Rupture

  IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED TWICE. THE FIRST INFLATION WAS DONE AT 10 ATMOSPHERES; HOWEVER, UPON THE SECOND INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED ALL TOGETHER WITH THE GUIDE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6801869 ↗