Ranger™ H74939733420020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506046675), received between Jan 20, 2026 and Mar 2, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 4.0 X 200 MM 200CM RANGER DRUG-COATED BALLOON CATHETER BALLOON WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED DURING THE FIRST INFLATION. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480468 ↗
• MalfunctionJan 20, 2026Entrapment of Device

  IT WAS REPORTED THAT STUCK ON GUIDEWIRE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 200 MM 200CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE DURING THIS ENDOVASCULAR THERAPY PROCEDURE. DURING THE PROCEDURE, THE RANGER DEVICE BECAME STUCK WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. IT WAS NOTED THAT THE GUIDEWIRE WAS INSERTED FROM THE TIP OF THE BALLOON AND THE GUIDEWIRE APPEARED FROM THE EXIT PORT. WHEN IT WAS ADVANCED FURTHER AND TRIED TO BE INSERTED INTO THE SHEATH, IT BECAME STIFF, AND THE GUIDEWIRE COULD NO LONGER BE ADVANCED. THE GUIDEWIRE WAS REMOVED FROM THE BALLOON, AND THE SURFACE OF THE GUIDEWIRE WAS WIPED AND WAS REINSERTED. HOWEVER, IT WOULD NO LONGER COME OUT FROM THE EXIT PORT; THEREFORE, A DIFFERENT DEVICE OF THE SAME SIZE WAS USED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121714 ↗