MUSTANG™ H74939171080670Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729793885), received between Jan 5, 2017 and Aug 3, 2026 — classified as 2 injuries, 15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50112127 ↗
• MalfunctionNov 14, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21OCT2025. IT WAS REPORTED THAT THE DIFFICULTY ADVANCING OCCURRED. AN 8.0 X 60, 75CM MUSTANG WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTA). HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT RESISTANCE WAS FELT WHEN ADVANCING INTO THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE LEAK IN THE SHAFT LOCATED APPROXIMATELY 135MM PROXIMAL FROM THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556047 ↗
• MalfunctionMay 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL. AN 8.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR LEFT BRACHIOCEPHALIC FISTULOPLASTY PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 15 ATMOSPHERES FOR LESS THAN 1 MINUTE. THE DEVICE WAS REMOVED WITHOUT ANY FRAGMENTS LEFT IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 8.0 X 60, 75CM MUSTANG BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995449 ↗
• MalfunctionJul 18, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28JUN2024. IT WAS REPORTED THAT BALLOON DAMAGED OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. AN 8.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, A LEAK WAS NOTED WITH THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19778682 ↗
• MalfunctionJun 20, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT BALLOON BECAME STUCK WITH THE GUIDEWIRE. AN 8.0 X 60, 75CM MUSTANG WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE IT WAS NOTED THAT THE GUIDEWIRES BECAME STUCK IN BALLOON WIRE SHAFT AFTER INSERTING INTO PATIENT. THE BALLOON AND GUIDEWIRE HAVE TO BE REMOVED AS ONE UNIT THROUGH SHEATH. THE BALLOON WAS DEFLATED PRIOR TO REMOVAL ATTEMPT AND WAS REMOVED INTACT. THE GUIDEWIRE WAS NOT ABLE TO BE REMOVED FROM THE DEVICE ONCE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19577086 ↗
• MalfunctionJun 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS FISTULA. AN 8.0 X 60, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 18 ATMOSPHERES FOR 30-40 SECONDS, THE BALLOON BURST. THE BALLOON WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565587 ↗
• MalfunctionMay 23, 2024Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT DIFFICULTY ADVANCING THROUGH SHEATH OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACHED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY. AN 8.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE BALLOON DID NOT GO THROUGH THE OPPOSITE SIDE OF THE NON-BOSTON SCIENTIFIC SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER COMPANY PRODUCT. NO COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A CIRCUMFERENTIAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387751 ↗
• MalfunctionMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS STENOSIS. A 8.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT FOUND THAT THE BALLOON BURST UNDER WORKING PRESSURE. 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 19374991 ↗
• MalfunctionApr 2, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. AN 8.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED UP TO 14 ATMOSPHERES FOR 2 MINUTES. WHEN TRYING TO DEFLATE THE BALLOON, IT WOULD NOT FULLY DEFLATE. AFTER SEVERAL MINUTES OF TRYING AND WAITING WITH NO SUCCESS, THE PHYSICIAN THEN USED A SYRINGE TO MANUALLY DEFLATE THE BALLOON. THE PHYSICIAN THEN CAREFULLY REMOVED THE BALLOON OVER THE WIRE WITH THE NURSE HOLDING ONTO THE INTRODUCER SHEATH. THE BALLOON WAS IN 10% UNDEFLATED STATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19025103 ↗
• MalfunctionFeb 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 8.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, BALLOON BURST OCCURRED UPON FIRST INFLATION AT 20 ATMOSPHERES FOR ONE MINUTE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655401 ↗
• MalfunctionJan 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 8.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610911 ↗
• MalfunctionJan 24, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-JAN-2023. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 8.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON WAS LEAKING. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16236856 ↗
• InjuryJul 26, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE AND REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH PORTAL HYPERTENSION. THE TARGET LESION WAS LOCATED IN THE HEPATIC PORTAL VEIN. A 8.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. WHEN DILATING THE MIDDLE PART OF THE COVERED STENT, THE MUSTANG BALLOON FAILED TO DEFLATE EVEN AFTER THE PRESSURE WAS REMOVED. THERE WAS NO RESPONSE AFTER MULTIPLE ATTEMPTS, A PUMP WAS USED TO APPLY MORE PRESSURE. IT WAS NOTED THAT THE BALLOON WOULD CONTINUE TO INFLATE WITH INCREASED PRESSURE BUT WOULD NOT DEFLATE DURING REMOVAL. EVENTUALLY, A PUNCTURE DEVICE WAS USED TO PUNCTURE THE BALLOON AND RELEASE THE PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107699 ↗
• MalfunctionJul 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN NON-TORTUOUS AND MILDLY CALCIFIED CEPHALIC VEIN. A 8.0 X 60, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. INFLATION WAS PERFORMED TWO TIMES. FIRST INFLATION WAS AT 10 ATMOSPHERES (ATM) AND SECOND INFLATION AT 6 ATM. HOWEVER, DURING THE SECOND INFLATION THE BALLOON BURST OUT BEFORE IT REACHES THE NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102823 ↗
• InjuryDec 10, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN A TORTOUS UNSPECIFIED VESSEL. A 8.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE BALLOON BROKE OFF IN THE PATIENT AND HAD TO BE RETRIEVED. BROKEN PIECES WERE REMOVED WITH A SNARE AND FORCEPS. THE DEVICE CAME OUT IN THREE PIECES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10988430 ↗
• MalfunctionFeb 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL OF THE LOWER LIMB. AN 8.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INITIALLY INFLATED AT 10 ATMOSPHERES; HOWEVER, ON THE SECOND INFLATION AT 6 ATMOSPHERES, 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 9742741 ↗
• MalfunctionJan 5, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS FOUND IN THE STERILE PACKAGING. A 8.0 X 60 MUSTANG¿ BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT A HAIR WAS FOUND IN THE STERILE PACKAGING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6225432 ↗