MUSTANG™ H74939171060610Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729793939), received between Jan 15, 2019 and Sep 14, 2026 — classified as 1 injury, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765836 ↗
• MalfunctionMay 4, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED POPLITEAL TO SUPERFICIAL FEMORAL ARTERY. A 6.0 X 60, 135CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BECAME FLAT LOOSE WITH A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80-90% STENOSED, SEVERELY TORTUOUS, AND SEVERELY CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25064580 ↗
• MalfunctionDec 1, 2024Inflation Problem; Material Integrity Problem; Inflation Problem; Material Integrity Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT A BALLOON PINHOLE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT LOWER EXTREMITY VESSEL. A 6.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS ADVANCED TO THE LESION, AND PRESSURIZATION WAS ATTEMPTED USING A PRESSURE PUMP AT 4 ATMOSPHERES. HOWEVER, THE BALLOON FAILED TO DILATE, AND CONTRAST MEDIUM LEAKAGE WAS OBSERVED. UPON WITHDRAWAL OF THE BALLOON, IT WAS NOTED THAT THE TIP WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATION REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20814881 ↗
• MalfunctionOct 29, 2024Leak/Splash; Difficult to Advance; Leak/Splash; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09OCT2024. IT WAS REPORTED THAT THE AMPLATZ WIRE COULD NOT CROSS THE BALLOON. DURING THE PROCEDURE, THE DEVICE WAS FLUSHED, AND THE AMPLATZ WAS UNABLE TO CROSS. AFTER MAKING SOME ADJUSTMENTS, THE BALLOON WAS ABLE TO CROSS. WHEN THE PRESSURE REACHED STANDARD PRESSURE, THE FIRST INFLATION AT 10 ATMOSPHERES FOR 1 MINUTE REVEALED A LEAKAGE FROM THE TIP OF THE BALLOON. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S STATUS AFTER THE OPERATION WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED TO BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560245 ↗
• MalfunctionAug 14, 2024Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 6.0 X 60, 135CM MUSTANG BALLOON WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE PACKAGING BOX WAS CRUMPLED AS IF IT HAD BEEN FOLDED IN HALF. CONSEQUENTLY, THE STERILITY OF THE BALLOON CATHETER WAS MOST LIKELY COMPROMISED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986722 ↗
• MalfunctionNov 23, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT SLOW DEFLATION ISSUE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN A NON-TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 6.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED TO 10 ATMOSPHERES FOR 30-40 SECONDS WITH A 50:50 SALINE CONTRAST RATIO. DURING REMOVAL, IT WAS NOTED THAT THE DEFLATION TIME WAS SLOW. THE BALLOON WAS REMOVED INTACT AND IN A DEFLATED STATE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15856749 ↗
• MalfunctionApr 22, 2022Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 6.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AFTER THE BALLOON WAS FULLY DEFLATED, THE BALLOON WOULD NOT RETRACT FROM A NON-BOSTON SCIENTIFIC (BSC) INTRODUCER SHEATH. BOTH THE SHEATH AND BALLOON WERE REMOVED TOGETHER AND SHAFT STRETCHING WAS OBSERVED. A DIFFERENT SHEATH WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189990 ↗
• MalfunctionFeb 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A 6.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INFLATION AT 5 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND NO BALLOON FRAGMENTS LEFT ON THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 50% STENOSED AND WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE BALLOON WAS INFLATED ONCE BEFORE IT RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11324402 ↗
• MalfunctionJan 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE BRACHEOCEPHALIC FISTULA. AFTER A 6FR SHEATH WAS PLACED, A 0.035 STIFF GUIDEWIRE WAS USED TO CROSS THE LESION. SUBSEQUENTLY, A 5.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED AT 20 ATMOSPHERES. A 6.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 22 ATMOSPHERES, THE BALLOON RUPTURED AGAIN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11187132 ↗
• InjuryNov 2, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 6.0 X 60 MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION BEFORE REACHING RATED BURST PRESSURE, THE BALLOON RUPTURED. UPON REMOVAL, A PIECE OF THE BALLOON APPEARED TO HAVE BEEN SHEARED OFF BY THE SHEATH. A CUTDOWN OPEN SURGERY WAS THEN PERFORMED TO REMOVE THE BALLOON DEBRIS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10776073 ↗
• MalfunctionJun 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE BRACHIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AV SHUNT AND SUBCLAVIAN VEIN. A 6.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INITIALLY INFLATED AT 10 ATMOSPHERES; HOWEVER, ON THE SECOND INFLATION AT BELOW THE NOMINAL PRESSURE, THE BALLOON RUPTURED. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8661197 ↗
• MalfunctionJan 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. TWO MUSTANG BALLOON CATHETERS (6.0 X 40,135CM AND 6.0 X 60,135CM) WERE ADVANCED FOR PRE-DILATATION. BOTH BALLOONS RUPTURED DURING FIRST INFLATION AT 10 ATMOSPHERES NOMINAL PRESSURE FOR 30 SECONDS AND CONTRAST LEAKAGE WAS NOTED. THE DEVICE WAS REMOVED. NON-BSC DEVICES ALSO RUPTURED. A DRUG-ELUTING STENT WAS DEPLOYED AND THE PROCEDURE COMPLETED. NO PATIENT SERIOUS INJURY OR ADVERSE EVENTS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281523 ↗
• 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 8246875 ↗