MUSTANG™ H74939171100610Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729795230), received between Dec 4, 2019 and Feb 11, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X 60, 135CM MUSTANG WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON NORMAL PRESSURE INFLATION AT 8 ATMOSPHERES FOR 2 MINUTES. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315684 ↗
• MalfunctionAug 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE GASTRIC CORONARY VEIN. A NON BOSTON SCIENTIFIC STENT 10.0 MM X 60 MM, 135 CM AND MUSTANG BALLOON CATHETER 10.0 MM X 60 MM, 135 CM WERE USED. DURING DEPLOYMENT, AIR LEAKAGE WAS OBSERVED IN THE BALLOON DESPITE EXTERNAL PRIMING. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE OF THE SAME TYPE. POST-PROCEDURAL ANGIOGRAPHY CONFIRMED PROPER STENT PLACEMENT AND PATENT BLOOD FLOW. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835278 ↗
• MalfunctionDec 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 10.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS BURST WHILE BLOWING IT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20908968 ↗
• MalfunctionJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED RIGHT CLAVICULAR VEIN. AFTER OBTAINING VASCULAR ACCESS VIA THE RIGHT ARM VEIN, THE GUIDEWIRE WAS PLACED AND THEN ANGIOGRAPHY WAS PERFORMED WHICH REVEALED THAT THE SECTION FROM THE RIGHT CLAVICULAR VEIN TO THE INNOMINATE VEIN HAD BEEN IMPLANTED WITH A NON-BOSTON SCIENTIFIC (BSC) STENT AND EXHIBITED IN-STENT RESTENOSIS (ISR). A 10.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR REVASCULARIZATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST WHEN THE PRESSURE REACHED 12 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A 10.0 X 80 BALLOON CATHETER. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531918 ↗
• MalfunctionNov 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VENA CAVA VEIN. A 10.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, ON THE FIRST INFLATION AT 8 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734934 ↗
• MalfunctionOct 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE INFERIOR VENA CAVA VEIN. A 10.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, THE BALLOON RUPTURED WHEN USING ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15676682 ↗
• MalfunctionAug 6, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN A VEIN. A 10.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING DEFLATION, THE BALLOON FAILED TO DEFLATE EVEN WITH MULTIPLE ATTEMPTS. THE BALLOON WAS REMOVED FULLY INFLATED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT TARGET LESION WAS MODERATELY STENOSED, NON-TORTUOUS, AND NON-CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291320 ↗
• MalfunctionJan 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFED SUBCLAVIAN VEIN. A 10.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, A LEAK OF THE CONTRAST MATERIAL WAS NOTED. A PINHOLE WAS ALSO NOTED ON THE BALLOON MATERIAL WHICH MAY HAVE CONTRIBUTED TO THE LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11207213 ↗
• MalfunctionJan 15, 2021Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CENTRAL VEIN. AFTER PLACING A 10FR SHEATH AND A 0.035" GUIDE WIRE, PRE-DILATATION WAS DONE WITH A 5X40MM BALLOON. A 10.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR FURTHER DILATATION. HOWEVER, DURING INFLATION, A LEAK OF THE CONTRAST MEDIA WAS NOTICED. THE DEVICE WAS REMOVED AND A PINHOLE WAS NOTED ON THE PROXIMAL PART OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11177397 ↗
• MalfunctionDec 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE POPLITEAL VEIN. A 10.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, HALF OF IT WAS INSIDE OF A WALLSTENT, THE OTHER HALF OF IT WAS IN THE ILIAC VEIN AND THE BALLOON BURST AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. ANOTHER 10.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS INSERTED INTO THE PATIENT. HOWEVER, DURING INFLATION, HALF OF IT WAS INSIDE OF A WALLSTENT, THE OTHER HALF WAS IN THE ILIAC AND IT ALSO BURST AT 8 ATMOSPHERES. WHEN THE DEVICE WAS REMOVED, THE SHAFT OF THE BALLOON BROKE OFF OF THE PROXIMAL PART OF THE BALLOON. THEY HAD TO REMOVE THE 8F NON-BSC SHEATH TO GET THE BALLOON AND THE REST OF THE SHAFT OUT OF THE POPLITEAL VEIN. THEY WERE ABLE TO RETRIEVE EVERYTHING OUT OF THE PATIENT'S BODY. INSERT A NEW SHEATH AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410224 ↗
• MalfunctionDec 4, 2019Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS POPLITEAL VEIN. A 10.0 X 60, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. WHEN THE BALLOON WAS INFLATED, HALF OF IT WAS INSIDE A WALLSTENT AND THE OTHER HALF WAS IN THE ILIAC VEIN. THE BALLOON RUPTURED AT 8 ATMOSPHERES AND WAS REPLACED WITH ANOTHER 10.0 X 60, 135CM MUSTANG BALLOON CATHETER. THE BALLOON WAS INFLATED IN THE SAME POSITION AND ALSO AT 8 ATMOSPHERES BUT THE BALLOON ALSO RUPTURED. IN AN ATTEMPT TO REMOVE THE DEVICE, THE PROXIMAL SHAFT BROKE OFF. THE DEVICE WAS COMPLETELY REMOVED TOGETHER WITH THE 8F SHEATH FROM THE POPLITEAL VEIN. A NEW SHEATH WAS INTRODUCED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410133 ↗