Ranger™ H74939419600810Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729976127), received between Jun 9, 2022 and Jul 31, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2025 AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 60 MM LESION LENGTH WITH 76% STENOSIS AND WAS CLASSIFIED AS TASC II CLASS B LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 1.7 MM TURBO ELITE ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 6 MM X 80 MM RANGER DRUG COATED BALLOON, STUDY DEVICE. FOLLOWING PROCEDURE, 6 MM X 80 MM NON - BSC DRUG ELUTING STENT WAS PLACED, AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2025, ON THE SAME DAY OF INDEX PROCEDURE, DURING THE TREATMENT OF TARGET LESION, LONG SEGMENT DISSECTION OF GRADE B WAS NOTED IN LEFT MID SUPERFICIAL FEMORAL ARTERY DUE TO 6 MM X 80 MM RANGER DRUG COATED BALLOON. THE SITE CONFIRMED THROUGH QUERY RESPONSE THAT ATHERECTOMY PROCEDURE PERFORMED PRIOR TO BALLOONING CAUSED THE

  Patient problems: Vascular Dissection

  MAUDE report 22680504 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY THAT A FLOW-LIMITING DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG-COATED BALLOONS ON (B)(6) 2023 AS A PART OF A CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT EXTERNAL ILIAC ARTERY, LEFT COMMON FEMORAL ARTERY, LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.8 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 132 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, LITHOTRIPSY WAS PERFORMED WITH SHOCKWAVE LITHOTRIPSY DEVICE AND PRE-DILATION WAS PERFORMED USING 2.5 MM X 150 MM COYOTE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE OF SIZE 5 MM X 200 MM AND 6 MM X 80 MM RANGER DRUG-COATED BALLOONS. DURING THE TREATMENT OF TARGET LESION, DISSECTION OF GRADE E WAS NOTED IN THE LEFT FEMOROPOPLITEAL JUNCTION. IT IS UNKNOWN WHICH DEVICE CAUSED THE DISSECTION. IN RESPONSE TO THE DISSECTION, A 6.0 MM X 120 MM ELUVIA DRUG-ELUTING STENT WAS PLACED IN THE LEFT DISTAL SFA AND WAS POST DILATED USING A STERLING BALLOON. POST TREATMENT, T

  Patient problems: Vascular Dissection

  MAUDE report 22439538 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED LESS THAN ONE YEAR POST INDEX PROCEDURE. ON (B)(6) 2023, THE INITIAL PROCEDURE OCCURRED TO TREAT THE PATIENT WITH PERIPHERAL VASCULAR DISEASE AND SIGNIFICANT CLAUDICATION. DURING THE PROCEDURE, RIGHT FEMORAL ANGIOGRAPHY, SELECTIVE LEFT LOWER EXTREMITY ANGIOGRAPHY, ATHERECTOMY, AND DRUG-COATED BALLOON ANGIOPLASTY OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WERE PERFORMED. PRE-PROCEDURE STENOSIS OF THE LEFT SFA WAS 99%, WITH A HEAVILY CALCIFIED MID SEGMENT AS WELL AS 90% STENOSIS IN A PREVIOUSLY PLACED STENT IN THE MID DISTAL SFA. ATHERECTOMY WAS PERFORMED USING A NON-BOSTON SCIENTIFIC DEVICE, FOLLOWED BY ANGIOPLASTY WITH A 6 MM X 80 MM RANGER DRUG-COATED BALLOON AT 17 ATM FOR 3 MINUTES, REDUCING STENOSIS FROM 99% TO 25%. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS, AND THE ACCESS SITE WAS CLOSED WITH AN ANGIO-SEAL. ON (B)(6) 2024, DUE TO RESTENOSIS OF THE TREATED SEGMENT, THE PATIENT UNDERWENT A SECOND INTERVENTION CONSISTING OF RIGHT FEMORAL ANGIOGRAPHY, SELECTIVE LEFT LOWER EXTREMITY ANGIOGRAPHY, ATHERECTOMY, AND REPEAT BALLOON ANGIOPLASTY. AFTER ACCESSING THE RIGHT COMMON FEMORAL ARTERY RETROGRADELY WITH A 7-FR CONTRALATERAL SHEATH,

  Patient problems: Restenosis

  MAUDE report 20845571 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT A DISSECTION OF GRADE D OCCURRED. THE SUBJECT UNDERWENT WITH A RANGER DRUG COATED BALLOON (DCB) AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2022 AS PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION #001 WAS LOCATED IN THE RIGHT MID AND PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 6MM, DISTAL VESSEL DIAMETER OF 6MM, LESION LENGTH OF 250MM, 70% STENOSIS, AND WAS CLASSIFIED AS TASC II B LESION. TREATMENT OF RIGHT PROXIMAL POPLITEAL ARTERY WAS PERFORMED BY DILATION WITH A 6 X 200MM RANGER DCB, FOLLOWED BY A 6 X 20 MM PERIPHERAL CUTTING BALLOON. THE TREATMENT OF RIGHT PROXIMAL SFA AND MID SFA WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 6.0 MM X 80 MM FOLLOWED BY PLACEMENT OF 6 MM X 120 MM ELUVIA DRUG ELUTING STENT. POST DILATION, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON (B)(6) 2022, DURING THE TREATMENT OF THE TARGET LESION #001, DISSECTION OF GRADE D WAS NOTED IN THE TARGET LESION DUE TO THE STUDY DEVICE RANGER DCB 6 X 80MM. IN RESPONSE TO THE DISSECTION NOTED, A 6MM X 120MM ELUVIA STENT WAS IMPLANTED AND A BALLOON DILATION WAS PERFORMED. FOLLOWING POST TRE

  Patient problems: Vascular Dissection

  MAUDE report 14644741 ↗