Ranger™ H74939419400410Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729975762), received between Mar 18, 2022 and Oct 22, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT OCCLUSION OF LEFT SUPERFICIAL FEMORAL ARTERY TO TIBIAL ARTERY. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT DISTAL POPLITEAL ARTERY AND LEFT ANTERIOR TIBIAL ARTERY WITH 3.7 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 3.8 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 20 MM WITH 90% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 4 MM X 40 MM RANGER DRUG COATED BALLOON, STUDY DEVICE. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2025, THE SUBJECT EXPERIENCED DISCOLORATION OF THE LEFT GREAT TOE FOR TWO DAYS. ON (B)(6) 2025, THE SUBJECT PRESENTED TO EMERGENCY DEPARTMENT (ED) WITH COMPLAINT OF LEFT LOWER EXTREMITY INTERMITTENT CLAUDICATION FOR PAST FOUR MONTHS. THE SUBJECT REPORTED THAT LEFT LOWER EXTREMITY PAIN WAS MOSTLY LOCALIZED IN CALF WHICH ONLY OCCURRED WHILE WALKING AND IMPROVED WITH REST; LEFT TOE DISCOLORATION WHICH WORSENED WHILE STANDING FOR LONG PERIOD AND IMPROVED WITH ELEVATIO

  Patient problems: Obstruction/Occlusion

  MAUDE report 23361178 ↗
• MalfunctionMar 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0 X 40MM, 135CM RANGER DRUG COATED BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON HAD A HOLE, PREVENTING IT FROM INFLATING PROPERLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825364 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY. IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. 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 LEFT DISTAL SFA WITH 5.00 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.00 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 60 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 5 MM X 60 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED WITH STUDY DEVICE, 5 MM X 60 MM RANGER DRUG COATED BALLOON. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. THE SECOND TARGET LESION WAS IN THE LEFT MID POPLITEAL ARTERY WITH 4.3 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.3 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 40 MM WITH 80 % STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATATION WAS PERFORMED USING 4 MM X 40 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED WITH STUDY DEVICE, 4 MM X 40 MM RANGER DRUG COATED BALLOON. THE FINAL RESI

  Patient problems: Vascular Dissection

  MAUDE report 15904570 ↗
• MalfunctionNov 21, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE DRUG ON THE BALLOON WAS MISSING. A RANGER PACLITAXEL-COATED PTA 4.0MM X 40MM, 135CM BALLOON CATHETER WAS SELECTED FOR ENDOVASCULAR THERAPY. DURING REMOVAL FROM THE PACKAGE, IT WAS NOTICED THAT THE DRUG ON THIS DEVICE LOOKED LIKE IT WAS MISSING. THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834216 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT THE PATIENT DEVELOPED ACUTE ISCHEMIA AND BILATERAL COMMON FEMORAL OCCLUSIONS. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT PROFUNDA FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 4 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4 MM WITH LESION LENGTH OF 40 MM AND 80% STENOSIS. PRE-DILATATION IN THE TARGET LESION WAS PERFORMED WITH A 4 MM X 135 MM LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 4 MM X 40 MM. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE SECOND TARGET LESION WAS IN THE RIGHT COMMON FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 60 MM AND 70% STENOSIS. PRE-DILATATION IN THE TARGET LESION WAS PERFORMED WITH A 5 MM X 110 MM LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 5 MM X 60 MM. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 25%.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 15180031 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT THE PATIENT DEVELOPED ACUTE ISCHEMIA AND BILATERAL COMMON FEMORAL OCCLUSIONS. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT PROFUNDA FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 4 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4 MM WITH LESION LENGTH OF 40 MM AND 80% STENOSIS. PRE-DILATATION IN THE TARGET LESION WAS PERFORMED WITH A 4 MM X 135 MM LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 4 MM X 40 MM. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE SECOND TARGET LESION WAS IN THE RIGHT COMMON FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 60 MM AND 70% STENOSIS. PRE-DILATATION IN THE TARGET LESION WAS PERFORMED WITH A 5 MM X 110 MM LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 5 MM X 60 MM. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 25%.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 15179963 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT CLAUDICATION AND OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG COATED BALLOONS (DCB) AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2022 AS PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT PROXIMAL POPLITEAL ARTERY, MID POPLITEAL ARTERY EXTENDING TO DISTAL POPLITEAL ARTERY. THE LESION HAD A PROXIMAL REFERENCE VESSEL DIAMETER OF 5MM, DISTAL REFERENCE VESSEL DIAMETER OF 5MM, LESION LENGTH OF 190MM, 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT, A NON BOSTON SCIENTIFIC (BSC) EMBOLIZATION PROTECTION DEVICE WAS USED AND PRE DILATION WAS PERFORMED WITH A 5MM X 150MM AND 4MM X 40MM NON-BSC BALLOONS. TREATMENT OF TARGET LESION WAS PERFORMED BY THE FOLLOWING RANGER DCB STUDY DEVICES: 4MM X 40MM, 5MM X 200MM AND 5MM X 60MM, RESPECTIVELY, FOLLOWED BY PLACEMENT OF A 6MM X 60MM ELUVIA DRUG ELUTING STUDY STENT. FOLLOWING POST DILATION WITH 5MM X 20MM NC EMERGE BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON (B)(6) 2022, THE SUBJECT VISITED THE HOSPITAL WITH SYMPTOMS RELATED TO CLAUDICATION. SEGMENTAL PRESSU

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion; Unspecified Vascular Problem

  MAUDE report 14639463 ↗
• InjuryMar 18, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE DISLODGED BALLOON LOADING TOOL. A 4.0 X 40MM, 135CM RANGER DRUG COATED BALLOON WAS SELECTED FOR USE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING DELIVERY OF THE BALLOON INTO THE PATIENT, THE PHYSICIAN NOTED MINIMAL RESISTANCE AS A 7FR SHEATH WAS USED. HOWEVER, THE LOADING TOOL ON THE BALLOON WAS NOT REMOVED AND INADVERTENTLY INSERTED INTO THE PATIENT AS THE PHYSICIAN STATED HE COULD NOT SEE IT UNDER THE C-ARM CAMERA. THE LOADING TOOL DISLODGED FROM THE BALLOON INTO THE PATIENT'S LEG. THE LOADING TOOL WAS ATTEMPTED TO BE EXTRACTED BUT IT WAS UNSUCCESSFUL. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE LOADING TOOL BY CUTTING DOWN TO THE SFA. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTERWARDS AND THEN DISCHARGED ON (B)(6) 2022. THE PATIENT WAS DOING WELL AND WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13805388 ↗