MUSTANG™ H74939171120410Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729793953), received between Dec 9, 2019 and Jun 2, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (20 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, 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 25359349 ↗
• MalfunctionJan 6, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED AORTA. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. 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 23973804 ↗
• MalfunctionNov 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 10% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 3 ATMOSPHERES FOR 6 SECONDS. 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 23447600 ↗
• MalfunctionOct 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY COMMON ILIAC ARTERY. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, AT 12 ATMOSPHERES THE BALLOON RUPTURED. 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 23373352 ↗
• MalfunctionNov 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON DEVELOPED A PUNCTURE AND SUBSEQUENTLY RUPTURED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662150 ↗
• MalfunctionMar 21, 2024Material 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 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948660 ↗
• MalfunctionJan 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 12 ATMOSPHERES FOR 30 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16248029 ↗
• MalfunctionNov 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MILDLY CALCIFIED COMMON ILIAC ARTERY. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15819405 ↗
• MalfunctionJul 29, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN CENTRAL VEIN. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INITIAL INFLATION, AT LESS WORKING PRESSURE FOR FEW SECONDS, THE BALLOON FAILED TO FULLY INFLATE, AND BURST DURING THE PROCESS. THE BALLOON DID NOT DETACH INSIDE THE PATIENT AFTER IT RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136083 ↗
• MalfunctionJul 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED BRACHIAL VEIN. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED VERTICALLY AT THE TIP. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15029231 ↗
• InjuryJun 15, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND DIFFICULTY REMOVAL OCCURRED RESULTING TO AN ADDITIONAL INTERVENTION. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS PULMONARY ARTERY. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING SECOND INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED HORIZONTALLY. THE DEVICE WAS REMOVED WITH A SNARE BECAUSE THE BALLOON WAS LIFTED AND WAS STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14698002 ↗
• MalfunctionNov 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. A 12.0 X 40, 135CM MUSTANG CATHETER WAS BEING USED FOR DILATION OF THE VENOUS ILIAC. THE BALLOON WAS INFLATED AND AFTER A FEW MINUTES, THE BALLOON BURST. A 12.0 X 60, 75CM MUSTANG CATHETER WAS USED; HOWEVER THE CARRIER BROKE IN THE MIDDLE OF THE BALLOON DURING THE PASSAGE OF THE FIBROUS LESION. THE BALLOON AND THE GUIDE ASSEMBLY WERE REMOVED FROM THE PATIENT. THE VASCULAR PATH WAS LOST AND THE INTERVENTION WAS INTERRUPTED. NO OTHER SURGICAL INTERVENTION WAS PLANNED FOR THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868668 ↗
• MalfunctionMay 7, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26-APR-2021. IT WAS REPORTED THAT SHAFT LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, DURING UNPACKING, IT WAS FOUND THAT THE TIP OF THE BALLOON CATHETER WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICAIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791935 ↗
• MalfunctionNov 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A VESSEL. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED BASED ON THE FLUOROSCOPY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10771411 ↗
• MalfunctionOct 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN A RENAL VESSEL. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT BELOW THE RATED BURST PRESSURE, THE BALLOON WOULD NOT INFLATE, AND LEAKING WAS NOTICED DUE TO A PINHOLE ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10759049 ↗
• MalfunctionOct 23, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30SEP2020. IT WAS REPORTED THAT BALLOON LEAK AND INFLATION FAILURE WERE ENCOUNTERED. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION IN A PERIPHERAL ANGIOPLASTY. HOWEVER, DURING INFLATION, IT WAS NOTED THAT THE BALLOON DID NOT REACH THE NOMINAL PRESSURE OF 10 ATMOSPHERES. AFTER CHECKING THE DEVICE OUTSIDE THE PATIENT, A BALLOON LEAK WAS NOTED. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10728953 ↗
• MalfunctionOct 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A RENAL VESSEL. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10725714 ↗
• MalfunctionOct 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USED. HOWEVER, DURING PREPARATION THERE WAS A HOLE NOTICED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10639345 ↗
• MalfunctionJun 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS SELECTED FOR TESTING. HOWEVER, DURING INITIAL INFLATION AT 4 ATMOSPHERES, A PIN HOLE LEAK WAS NOTED. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10130611 ↗
• MalfunctionMar 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, IT WAS NOTICED THAT THE BALLOON DID NOT REACH AT 14 ATMOSPHERES. INITIALLY, IT WAS BELIEVED THAT THE LESION WAS ELASTIC AND WOULD REQUIRE A HIGH PRESSURE BALLOON. WHEN THE BALLOON WAS REMOVED AND INFLATED OUTSIDE THE PATIENT, IT WAS VERIFIED THAT THE BALLOON WAS PUNCTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9866362 ↗
• MalfunctionMar 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS 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 9841361 ↗
• MalfunctionDec 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE WAS ENCOUNTERED. A 12.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, IT WAS NOTICED THAT THE BALLOON DID NOT HOLD PRESSURE AND A SMALL HOLE IN THE PROXIMAL PORTION WAS OBSERVED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9438331 ↗