MUSTANG™ H74939171040210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729793724), received between Sep 29, 2020 and Jun 17, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2022Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEFLATION FAILURE, REMOVAL DIFFICULTY AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN SUPERFICIAL FEMORAL ARTERY. A 4.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED AT 10 ATMOSPHERES FOR 2 MINUTES. HOWEVER, DURING DEFLATION, THE BALLOON FAILED TO DEFLATE. TO REMOVE THE BALLOON, THEY FIRST PULLED NEGATIVE WITH THE STOPCOCK ON, THEN OFF, BUT IT STILL DID NOT COME DOWN. THE SHEATH WAS THEN USED TO SWALLOW THE BALLOON, BUT IT WAS DIFFICULT TO DO SO. THE SHAFT TO THE BALLOON BROKE AS IT WAS PULLED INTO THE SHEATH. THE SURGEON HAD TO POP THE BALLOON TO REMOVE IT. IT ENDED COMING OUT IN TWO PIECES AND DETACHED FROM THE SHAFT. THE PROCEDURE COULD NOT BE COMPLETED AS HE LOST ACCESS DUE TO THE REMOVAL OF THE BALLOON. ADDITIONAL PROCEDURE WAS TO BE RE-SCHEDULED, AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14733984 ↗
• MalfunctionJan 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 4.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION AT 10 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 NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11228527 ↗
• MalfunctionJan 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11194484 ↗
• MalfunctionSep 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED POPLITEAL ARTERY. A 4.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATIONS. HOWEVER, DURING INITIAL INFLATION BEFORE RATED BURST PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10603892 ↗