Ranger™ H74939419601080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729976158), received between Jun 21, 2021 and Mar 30, 2026 — classified as 5 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 16, 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.

• MalfunctionMar 30, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 6.0 X 100MM, 80CM RANGER DRUG COATED BALLOON WAS SELECTED FOR USE. DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED VERTICALLY AT THE MIDDLE. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 24727177 ↗
• MalfunctionMar 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE . A 6.00MM / 2.0CM / 90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 8 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 REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21552372 ↗
• MalfunctionNov 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BALLOON CATHETER GOT STUCK WITH A STENT. A RANGER PACLITAXEL-COATED PTA 6.0MM X 100MM, 80CM BALLOON CATHETER WAS SELECTED FOR ENDOVASCULAR THERAPY TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS BEING PERFORMED TO TREAT 75% STENOSIS, AND THE TARGET LESION CONTAINED MILD CALCIFICATION AND MODERATE TORTUOSITY. DURING THE PROCEDURE, THE BALLOON CATHETER BECAME STUCK WITH ANOTHER MANUFACTURER STENT. THE CATHETER WAS REMOVED AS INTENDED, AND NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED, AS ANOTHER OF THE SAME DEVICE WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735716 ↗
• MalfunctionMay 19, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE AND GUIDEWIRE BECAME STUCK. A RANGER 6.0MM X 100MM, 80CM WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY (SFA) ATHERECTOMY PROCEDURE FOR PERIPHERAL ARTERY DISEASE. THE 90% STENOSED TARGET LESION HAD MODERATE CALCIFICATION AND TORTUOSITY. DURING THE PROCEDURE WHILE INSIDE THE PATIENT, THIS RANGER DEVICE GOT STUCK WITH A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE AND HAD TO BE REMOVED TOGETHER. IT WAS NOTED THAT THE NON-BSC GUIDEWIRE WAS POSSIBLY KINKED BEFORE IT WAS USED, AND THE DEVICE GOT STUCK BEFORE REACHING THE LESION. THIS CATHETER WAS NOT USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW GUIDEWIRE AND RANGER WITHOUT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14442458 ↗
• MalfunctionJun 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A RANGER 6X100X80 DRUG COATED BALLOON WAS SELECTED FOR USE IN A VASODILATATION PROCEDURE IN A SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS 99% STENOSED, MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE BALLOON WAS INFLATED FOR 10 SECONDS AT 6 ATMOSPHERES AND WHEN THE INFLATION DEVICE WAS ROTATED TO APPLY MORE PRESSURE, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED AND 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 12033155 ↗