MUSTANG™ H74939171041010Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729793717), received between Jul 11, 2019 and Jan 15, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Nonstandard Device; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LIMB ARTERY. A 4.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED OVER THE GUIDEWIRE FOR DILATION. DURING INFLATION, THE BALLOON CRACKED. THE BALLOON WAS IMMEDIATELY WITHDRAWN AND A NEW ONCE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 100% STENOSED, MILDLY TORTUOUS, AND SEVERELY CALCIFIED. ADDITIONALLY, THE DEVICE USED IN THIS PROCEDURE WAS A 3 MM X 150 MM STERLING BALLOON DILATION CATHETER. WHEN THE BALLOON REACHED THE RATED PRESSURE OF 6 ATM, A "POP" SOUND WAS HEARD. THE ANGIOGRAPHY REVEALED THAT THE BALLOON HAD RUPTURED INSIDE THE BODY. THEREFORE, THE DAMAGED BALLOON WAS SLOWLY REMOVED. AN EXTERNAL EXAMINATION OF THE "CORPSE" OF THE BALLOON SHOWED THAT IT WAS INCOMPLETE, AND SOME OF THE BALLOON'S OUTER SKIN HAD FALLEN INTO THE BLOOD VESSELS. ADDITIONALLY, IT WAS CONFIRMED THAT THE BALLOON DELIVERY CATHETER, TOGETHER WITH THE DAMAGED BALLOON, WAS REMOVED DIRECTLY ALONG THE GUIDEWIRE. THE BALLOON DEBRIS REMAINING IN THE BLOOD VESSELS WAS REMOVED USING A CAPTURE DEVICE. THE BALLOON WAS NOT INFLATED AND USED

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081665 ↗
• MalfunctionAug 7, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT TIP DAMAGE OCCURRED. A 4.0 X 100, 135 CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING INSERTION INTO THE GUIDE CATHETER, IT WAS NOTED THAT THE TIP HAS A BEVELED CUT. THE DEVICE WAS NOT USED IN THE PATIENT 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 22742350 ↗
• MalfunctionMay 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 4.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE SECOND INFLATION AT 18 ATMOSPHERES FOR 30SECONDS. 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 22032382 ↗
• MalfunctionSep 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 10 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 INJURIES REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503230 ↗
• MalfunctionMay 17, 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 SUPERFICIAL FEMORAL ARTERY. A 4.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE DEVICE WAS INFLATED TWICE AT 24 ATMOSHERES (ATM). HOWEVER,DURING THIRD INFLATION AT 24 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832977 ↗
• MalfunctionDec 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY UTILIZING A CONTRALATERAL APPROACH. THE STENOSED TARGET LESION WAS LOCATED IN THE RIGHT POPLITEAL ARTERY. AFTER A GUIDEWIRE CROSSED THE LESION, A 4.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 15 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11023972 ↗
• MalfunctionMay 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD INFLATION AT 18 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED 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 10026521 ↗
• MalfunctionNov 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING A PROCEDURE INVOLVING A 4.0 X 100, 135CM MUSTANG BALLOON CATHETER, THE BALLOON RUPTURED ON THE SECOND INFLATION AT 18 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9293203 ↗
• MalfunctionJul 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 4.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED. 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 8783135 ↗