Ranger™ H74939419500680Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729975953), received between Mar 2, 2023 and Apr 24, 2025 — classified as 5 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.

• MalfunctionApr 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 60MM, 80CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 6 ATMOSPHERES FOR ABOUT 10 SECONDS, THE BALLOON RUPTURED IN A PINHOLE FORM AT THE MIDDLE PART. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 21903996 ↗
• MalfunctionJul 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 60MM, 80CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19778773 ↗
• MalfunctionFeb 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WITH STRAIGHT GEOMETRY WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. FOLLOWING PRE-DILATATION, A 5.0X 60MM, 80CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED THROUGH THE SHEATH WITH A LOADING TOOL. HOWEVER, DURING THE INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 18703918 ↗
• MalfunctionJul 25, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN THE LEFT SUPERFICIAL FEMORAL ARTERY. VASCULAR ACCESS WAS OBTAINED VIA AN IPSILATERAL APPROACT. THE TARGET LESION WAS 90% STENOSED WITH MODERATE CALCIFICATION AND TORTUOSITY. THE LESION WAS PRE-DILATED WITH A NON-BSC BALLOON. THE RANGER BALLOON WAS THEN ADVANCED TO THE TARGET LESION. RESISTANCE WAS NOTED DUE TO THE CALCIFICATION. DURING THE FIRST INFLATION AT 14ATM, THE BALLOON RUPTURED AFTER 30 SECONDS. THE DEVICE WAS REMOVED, AND A NON-BSC BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17392723 ↗
• MalfunctionMar 2, 2023Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON WAS LEAKING CONTRAST MEDIA, AND WAS DEFLATING SLOWLY. A RANGER 5X6MM WAS SELECTED FOR USE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) TO TREAT THE PATIENT'S STENOSIS. THE TARGET LESION WAS REPORTED TO BE 90% STENOSED WITH MILD TORTUOSITY AND CALCIFICATION. THE LESION WAS PREDILATED USING A WOLVERINE 4MM. THE RANGER WAS ADVANCED TO THE TARGET LESION AND ATTEMPTED TO BE INFLATED AT 6 ATM, BUT THE PRESSURE DECREASED. THE BALLOON WAS ATTEMPTED TO BE DEFLATED BUT WAS DEFLATING SLOWLY. THE BALLOON WAS ABLE TO FULLY DEFLATE AND WAS REMOVED FROM THE PATIENT. WHEN INSPECTED OUTSIDE OF THE PATIENT, IT WAS REPORTED THAT CONTRAST MEDIA WAS LEAKING FROM THE BALLOON. THE RANGER WAS REPLACED WITH ANOTHER IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16468895 ↗