Ranger™ H74939419701510Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729976349), received between Sep 29, 2021 and Feb 24, 2022 — classified as 2 injuries.

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.

• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT EMBOLISM OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT COMMON FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 7 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 7 MM WITH LESION LENGTH OF 130 MM AND 90% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II A LESION. PRIOR TO TARGET LESION TREATMENT, LITHOTRIPSY WAS PERFORMED WITH SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) DEVICE, 6 X 60 MM AND TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH STUDY DEVICE (RANGER DRUG COATED BALLOON OF 7.0 MM X 150 MM) PRIOR TO LITHOTRIPSY, ATHERECTOMY WAS PERFORMED WITH A NOB-BOSTON SCIENTIFIC CORONARY ORBITAL ATHERECTOMY SYSTEM. ON (B)(6) 2021, AFTER THE COMPLETION OF THE INDEX PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY (TARGET LESION), THE RIGHT FOOT WAS NOTED TO BE PALE AND COLD. THE SUBJECT HAD A COMPLAINT OF PAIN IN THE RIGHT LEG. SUBSEQUENTLY, ANGIOGRAM WAS PERFORMED WHICH DEMONSTRATED NO FLOW TO THE FOOT WHICH WAS UNCHANGED FROM PRIOR ANGIOGRAM AND EMBOLISM WAS NOTED IN THE FOOT WHI

  Patient problems: Embolism/Embolus; Pain; Restenosis; Vascular Dissection

  MAUDE report 13593785 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY: IT WAS REPORTED THAT CELLULITIS AND TOE AMPUTATION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2021 AS A PART OF THE (B)(6) CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE LEFT PROXIMAL POPLITEAL ARTERY WITH UNKNOWN PROXIMAL AND DISTAL REFERENCE VESSEL DIAMETER, UNKNOWN LENGTH AND 90% STENOSIS. PRE-DILATATION WAS NOT PERFORMED, AND TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH STUDY DEVICES, RANGER DRUG COATED BALLOONS 6 MM X 200 MM, 5 X 80 MM AND 5 X 120 MM. NO ADJUNCTIVE DEVICES WERE USED. THE SECOND TARGET LESION WAS LOCATED IN THE LEFT EXTERNAL ILIAC ARTERY EXTENDING TO LEFT COMMON FEMORAL ARTERY WITH UNKNOWN PROXIMAL AND DISTAL REFERENCE VESSEL DIAMETER, UNKNOWN LENGTH AND 100% STENOSIS (CHRONIC TOTAL OCCLUSION). PRE-DILATATION WAS PERFORMED WITH CHARGER PTA BALLOON 5 MM X 150 MM AND TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON 7 MM X 150 MM. POST TARGET LESION TREATMENT WAS DONE BY STENTING WITH 8 MM X 37 MM EXPRESS LD OTW BARE METAL STENT AND 8 MM X 57 MM EXPRESS LD OTW BARE METAL STENT AS ADJUNCTIVE DEVICES. THE PROXIMAL SUPERFICIAL FE

  Patient problems: Cellulitis; Embolism/Embolus; Necrosis; Restenosis

  MAUDE report 12548739 ↗