Ranger™ H74939419601210Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729976165), received between Jan 20, 2022 and Jan 3, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 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.

• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT RESTENOSIS, VESSEL OCCLUSION, CLAUDICATION, AND PAIN OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 150 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 1.4 MM X 150 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE, PRE-DILATION WAS PERFORMED USING 3 MM X 200 MM NON-BSC PTA BALLOON AND 4 MM X 200 MM AND 6 MM X 200 MM NON-BSC PTA BALLOONS. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 6 MM X 120 MM RANGER DRUG COATED BALLOON STUDY DEVICE. FOLLOWING, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 40%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2023, SUBJECT VISITED THE HOSPITAL WITH THE COMPLAINTS OF BILATERAL LE PAIN WITH AMBULATION THE CLAUDICATION OF RIGHT LE WAS DISABLING IN NATURE AND WAS NOTED WITH SYMPTOMS RE

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion; Pain; Restenosis

  MAUDE report 18439921 ↗
• MalfunctionJan 20, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE RO MARKERS ON THE BALLOON COULD NOT BE SEEN. A 6MM X 120MM, 150CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY INTERVENTION. DURING THE PROCEDURE, THE RO MARKERS COULD NOT BE SEEN ON THE BALLOON. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13310985 ↗