MUSTANG™ H74939171042010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729793595), received between Dec 11, 2019 and Aug 21, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2026Difficult to Remove; Material Rupture

  The balloon was difficult to remove requiring intervention.The target lesion was located in the Femoral artery. A 4.0 x 200, 135cm Mustang balloon catheter was advanced for dilation. During the procedure, it was noted that the balloon could not fold back spontaneously to the original outer diameter, the resistance was great during withdrawal, and it could not be recaptured in the sheath smoothly. Forced retraction of the balloon caused intimal injury to the blood vessel and punctured the balloon during removal. The procedure was completed with another of the same device. There were no patient complications as a result of this event.

  Patient problems: Perforation of Vessels

  MAUDE report 50374489 ↗
• MalfunctionJan 30, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION THROUGH A 0.035 GUIDEWIRE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED WITH THE ENCORE INFLATION DEVICE AT A NOMINAL PRESSURE, HOWEVER, IT WAS IMMEDIATELY NOTED THAT THE BALLOON IS DEFLATING THROUGH A HOLE LOCATED AT THE DISTAL END. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607512 ↗
• MalfunctionJan 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED VESSEL. A 4.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DAMAGE POSITION WAS 3CM FROM THE MARK POINT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544444 ↗
• MalfunctionSep 22, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND BALLOON DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE INFERIOR FEMORAL ARTERY. A 4.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE PHYSICIAN RELEASED THE PRESSURE AFTER DILATION, THE BALLOON COULD NOT BE WITHDRAWN. EVENTUALLY, THE PHYSICIAN REMOVED THE BALLOON AND THE SHEATH AND NOTICED THAT THE BALLOON WAS DISLODGED. THE DISLODGED BALLOON WAS SIMPLY PULLED OUT AND REMOVED FROM THE PATIENT'S BODY. THE PHYSICIAN DECIDED NOT TO PROCEED AND ABORTED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10571287 ↗
• MalfunctionDec 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERELY STENOSED, TARGET LESION WAS LOCATED IN THE SUPERIOR FEMORAL ARTERY. A 4.0 X 200, 135CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT WHEN IT WAS PRE-DILATED FROM THE SUPERIOR FEMORAL ARTERY TO ILIAC, THE BALLOON BURST. 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 9453504 ↗