Ranger™ H74939419400810Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729975809), received between Sep 17, 2021 and Dec 2, 2025 — classified as 1 death, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OF LEFT POPLITEAL ARTERY OCCURRED. ON (B)(6) 2025 REVEALED THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT MID POPLITEAL ARTERY WITH 4MM PROXIMAL REFERENCE VESSEL DIAMETER AND 3MM DISTAL REFERENCE VESSEL DIAMETER WITH 80MM LESION LENGTH AND 99% STENOSIS AND CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, LITHOTRIPSY WAS PERFORMED WITH 3.0MM SHOCKWAVE INTRAVASCULAR LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 4MM X 80MM RANGER DRUG-COATED BALLOON STUDY DEVICE. FOLLOWING POST TREATMENT, DILATION WAS PERFORMED BY USING 4MM X 150MM JADE PTA BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2025, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF WORSENING REST PAIN IN THE LEFT CALF AND FOOT FROM PAST 3 MONTHS. SUBJECT WAS PLANNED TO UNDERGO LEFT LOWER EXTREMITY ANGIOGRAM ON (B)(6) 2025 HOWEVER, WAS CANCELLED. ON THE SAME DAY, THE SUBJECT WAS ADMITTED TO VASCULAR SURGERY FOR MONITORING

  Patient problems: Pain; Restenosis

  MAUDE report 23696719 ↗
• InjuryOct 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING ADDITIONAL INTERVENTION. 08-SEP-2022, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS AS A PART OF A CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT DISTAL POPLITEAL ARTERY AND RIGHT TIBIAL PERONEAL TRUNK WITH 4.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4 MM DISTAL REFERENCE VESSEL DIAMETER WITH 60 MM LESION LENGTH WITH 99 % STENOSIS AND WAS CLASSIFIED AS TASC II CLASS C LESION. PRIOR TO TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 1.5 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED USING 3 MM X 40 MM COYOTE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 4 MM X 80 MM RANGER DRUG COATED BALLOON STUDY DEVICE. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. THE SECOND TARGET LESION WAS IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY AND RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 120 MM LESION LENGTH WITH 70 % STENOSIS AND WAS CLASSIFIED AS TASC II CLASS B LESION. PRIOR TO TREATMENT OF TARGET LESION WI

  Patient problems: Restenosis

  MAUDE report 23222235 ↗
• InjuryOct 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING ADDITIONAL INTERVENTION. ON (B)(6) 2022, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AS A PART OF THE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT DISTAL POPLITEAL ARTERY AND RIGHT TIBIAL PERONEAL TRUNK WITH 4.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4 MM DISTAL REFERENCE VESSEL DIAMETER WITH 60 MM LESION LENGTH WITH 99 % STENOSIS AND WAS CLASSIFIED AS TASC II CLASS C LESION. PRIOR TO TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 1.5 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE, PRE-DILATION WAS PERFORMED USING 3 MM X 40 MM COYOTE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 4 MM X 80 MM RANGER DRUG COATED BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. THE SECOND TARGET LESION WAS IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY AND RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 120 MM LESION LENGTH WITH 70 % STENOSIS AND WAS CLASSIFIED AS TASC II CLASS B LESION. PRIOR TO TREATMENT OF TARGET LESION WITH THE STUDY

  Patient problems: Restenosis

  MAUDE report 23221866 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISSECTION OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AS PART OF CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT PROXIMAL POPLITEAL ARTERY, AND RIGHT DISTAL POPLITEAL ARTERY WITH 4 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 300 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 300 MM AND 70% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 4 MM X 300 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. POST TARGET LESION TREATMENT WAS PERFORMED BY PLACEMENT OF 5 MM X 80 MM, 5 MM X 200 MM, AND 5 MM X 40 MM INNOVA BARE METAL STENTS, AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY, DURING THE TREATMENT OF TARGET LESION, DISSECTION OF GRADE D WAS NOTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY DUE TO 4 MM X 300 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. IN RESPONSE TO THE EVENT, BAILOUT STENT WAS PLACED. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED AND THE S

  Patient problems: Obstruction/Occlusion; Vascular Dissection; Vasoconstriction

  MAUDE report 22057097 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY IT WAS REPORTED THAT A TARGET LESION REVASCULARIZATION (TLR) OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER PACLITAXEL-COATED PTA BALLOON CATHETER ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT MID-SFA EXTENDING UP TO RIGHT DISTAL-SFA WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.0 MM DISTAL REFERENCE VESSEL DIAMETER. THE LESION LENGTH OF 60 MM AND 100% STENOSIS (CLASSIFIED AS TASC II A LESION). PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 80 MM ARMADA 35 OTW PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE OF SIZE 4 MM X 80 MM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF INTERMITTENT CLAUDICATION. ON THE SAME DAY, RIGHT LOWER EXTREMITY ANGIOGRAPHY REVEALED OCCLUSION OF THE RIGHT PROXIMAL-SFA, MID-SFA AND DISTAL-SFA. ADDITIONAL TREATMENT AS PERFORMED WIT

  Patient problems: Arteriosclerosis/ Atherosclerosis; Restenosis

  MAUDE report 17034993 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY. IT WAS REPORTED THAT OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT PERONEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 4.0 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4.0 MM WITH LESION LENGTH OF 60 MM AND 100% STENOSIS. PRIOR TO TARGET LESION TREATMENT, PRE DILATION WAS PERFORMED USING 3.5 MM X 100 MM AND 4.0 MM X 120 MM STERLING PTA BALLOON. TREATMENT OF FIRST TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON 4.0 MMX 60 MM. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. THE SECOND TARGET LESION WAS IN THE RIGHT PROXIMAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.2 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.2 MM WITH LESION LENGTH OF 100 MM AND 100% STENOSIS. PRIOR TO TARGET LESION TREATMENT PRE DILATION WAS PERFORMED USING 3.5 MM X 100 MM AND 4.0 MM X 120 MM STERLING PTA BALLOON. TREATMENT OF SECOND TARGET LESION WAS PERFORMED BY DILATION OF STUDY DEVICE, RANGER DRUG COATED BALLOON 5.00 MM X 80 MM. POST TARGET LESION TREATMENT, 6 MM X 80 MM NO

  Patient problems: Arteriosclerosis/ Atherosclerosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14646708 ↗
• DeathSep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE SUBJECT DIED. ON (B)(6) 2021 , THE SUBJECT UNDERWENT TREATMENT WITH A 4.0 X 80MM, 135CM RANGER DRUG COATED BALLOON. THE TARGET LESION WAS 80 MM LONG, LOCATED IN THE LEFT PROXIMAL POPLITEAL ARTERY AND MID POPLITEAL ARTERY. POST DILATATION WAS PERFORMED USING A STERLING OTW, 5 MM X 80 MM AS AN ADJUNCTIVE DEVICE TO TREAT THE TARGET LESION, RESIDUAL STENOSIS WAS UNKNOWN. ON (B)(6) 2021, 17 DAYS POST-INDEX PROCEDURE, IT WAS REPORTED THE SUBJECT EXPIRED IN AN OUTLYING HOSPITAL. A DEATH CERTIFICATE IS NOT AVAILABLE, AND IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED OR NOT.

  Patient problems: Insufficient Information

  MAUDE report 12492492 ↗