MUSTANG™ H74939171080270Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729793519), received between Feb 14, 2019 and Dec 11, 2024 — classified as 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL COMMON ILIAC ARTERY. A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 12 ATMOSPHERES FOR 5 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 20903788 ↗
• MalfunctionApr 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND 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 19140439 ↗
• MalfunctionOct 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE IN AN ENDOVASCULAR THERAPY (EVT). HOWEVER, DURING INITIAL INFLATION AT 8 ATMOSPHERES (ATM) FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616593 ↗
• MalfunctionOct 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ARTERIOSCLEROSIS. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. AN 8.0 X 20, 75CMN MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE EIGHTH INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15570863 ↗
• MalfunctionOct 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC VESSEL. A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED AT THE MIDDLE PART OF THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538338 ↗
• MalfunctionJun 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 10.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED; HOWEVER, DURING THE INITIAL INFLATION, THE BALLOON ALSO RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14788179 ↗
• MalfunctionNov 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. INFLATION WAS PERFORMED THREE TIMES AT 18 ATMOSPHERES FOR 30 SECONDS. HOWEVER, DURING THE THIRD INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866013 ↗
• MalfunctionOct 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS OPENED DURING PREPARATION, A SMALL PIECE OF FOREIGN MATERIAL WAS NOTED INSIDE THE INNER POUCH COMPROMISING THE STERILITY OF THE DEVICE. IT WAS NOTED THAT THE INNER POUCH OF THE PACKAGE WAS INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711410 ↗
• MalfunctionJul 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA IPSILATERAL RETROGRADE APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. AFTER A GUIDEWIRE WAS CROSSED THE LESION, AN 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WHICH ALSO RUPTURED DURING FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 7MM MUSTANG BALLOON CATHETER AND PLACEMENT OF A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195827 ↗
• MalfunctionJul 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA IPSILATERAL RETROGRADE APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. AFTER A GUIDEWIRE WAS CROSSED THE LESION, AN 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WHICH ALSO RUPTURED DURING FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 7MM MUSTANG BALLOON CATHETER AND PLACEMENT OF A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194613 ↗
• MalfunctionMay 3, 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 EXTERNAL ILIAC ARTERY. A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FOURTH INFLATION AT 12 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766229 ↗
• MalfunctionApr 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC. AN 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615952 ↗
• MalfunctionOct 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY ISSUE NOTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10677041 ↗
• MalfunctionMay 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. AN 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT 24 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10069317 ↗
• MalfunctionMar 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9895110 ↗
• MalfunctionFeb 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY UTILIZING A CONTRALATERAL APPROACH. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT COMMON FEMORAL ARTERY. A 6F NON-BSC INTRODUCER SHEATH WAS INSERTED AND A NON-BSC GUIDEWIRE CROSSED THE LESION BUT SEVERE CALCIFICATION WAS OBSERVED AND SO PRE-DILATION WAS PERFORMED WITH A 6MMX2CM PCB BALLOON CATHETER AT 6 ATMOSPHERES. AND THEN, A 8.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 4 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. SUBSEQUENTLY, A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED BUT IT ALSO RUPTURED AT 6 ATMOSPHERES FOR 5 SECONDS. A NON-BSC BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752300 ↗
• MalfunctionDec 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 20 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT AN 8.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS USED FIRST AND WHEN THE BALLOON RUPTURED, AN 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS USED BUT IT RUPTURED AS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9415777 ↗
• MalfunctionNov 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. AN 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER,DURING INFLATION, THE PRESSURE COULD NOT BE INCREASED. WHEN THE DEVICE WAS PULLED OUT, LEAKAGE IN THE PROXIMAL END OF THE BALLOON WAS NOTED AND THERE APPEARED TO BE A PINHOLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT IS FURTHER REPORTED THAT THERE WAS NO VISIBLE PINHOLE FOUND BEFORE INFLATION AND IT WAS AFTER THE THIRD INFLATION THAT THE LEAKAGE WAS NOTED IN PROXIMAL OF THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9345594 ↗
• MalfunctionApr 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT SERIOUS INJURY NOR ADVERSE EVENT WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562118 ↗
• MalfunctionFeb 14, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY (CIA). A 8.0 X 20 MUSTANG BALLOON CATHETER WAS ADVANCE FOR DILATION. HOWEVER, BALLOON RUPTURED AT BELOW RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339603 ↗