Ranger™ H74939419501210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729976004), received between Sep 29, 2021 and Mar 5, 2025 — classified as 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLICATION OCCURRED POST PROCEDURE REQUIRING ADDITIONAL INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOON ON (B)(6) 2024 AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION WAS IN RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) AND RIGHT PROXIMAL POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 30 MM LESION LENGTH AND 50% STENOSIS. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING OF 5 MM X 150 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. THE ANGIOGRAM REVEALED GREATER THAN 70% STENOSIS IN RIGHT DISTAL SFA, POPLITEAL ARTERY AND 5 MM RANGER DCB (STUDY DEVICE) WAS USED IN THE TREATMENT OF RIGHT SFA AND POPLITEAL ARTERY. ON THE NEXT DAY, (B)(6) 2024, THE SUBJECT HAD EXCISIONAL DEBRIDEMENT OF 2 X 3 CM SUBCUTANEOUS TISSUE ON THE RIGHT LATERAL FOOT OVER THE FIFTH METATARSAL HEAD. THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2024, THE SUBJECT VISITED THE HOSPITAL FOR WOUND CHECK AND REPORTED OF HAVING MILD REDNESS AND IRRITATION IN RIGHT FOOT POST MORNING WALK. PHYSICAL EXAMINA

  Patient problems: Cellulitis; Ischemia; Restenosis; Skin Inflammation/ Irritation

  MAUDE report 21527786 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT THROMBOTIC OCCLUSIONS OCCURRED. ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOONS (DCB) AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE LEFT DISTAL POPLITEAL ARTERY AND LEFT TIBIAL PERONEAL TRUNK WITH 4.0MM PROXIMAL REFERENCES VESSEL DIAMETER AND 3.5MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 40MM AND 70% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO TREATMENT, LITHOTRIPSY WAS PERFORMED USING 4 MM X 40 MM NON-BOSTON SCIENTIFIC (BSC) LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5.0 X 120MM, 150CM RANGER DCB. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. THE SECOND TARGET LESION WAS LOCATED IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA), LEFT DISTAL SFA, EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY (POP), WITH 6MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 300MM AND 70% STENOSIS AND WAS CLASSIFIED AS A TASC II C LESION. PRIOR TO TREATMENT, LITHOTRIPSY WAS PERFORMED USING A 5.5MM X 60MM A

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20305972 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY IT WAS REPORTED THAT THROMBOTIC OCCLUSIONS OCCURRED. ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOONS (DCB) AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE LEFT DISTAL POPLITEAL ARTERY AND LEFT TIBIAL PERONEAL TRUNK WITH 4.0MM PROXIMAL REFERENCES VESSEL DIAMETER AND 3.5MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 40MM AND 70% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO TREATMENT, LITHOTRIPSY WAS PERFORMED USING 4 MM X 40 MM NON-BOSTON SCIENTIFIC (BSC) LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5.0 X 120MM, 150CM RANGER DCB. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. THE SECOND TARGET LESION WAS LOCATED IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA), LEFT DISTAL SFA, EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY (POP), WITH 46MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 300MM AND 70% STENOSIS AND WAS CLASSIFIED AS A TASC II C LESION. PRIOR TO TREATMENT, LITHOTRIPSY WAS PERFORMED USING A 5.5MM X 60MM A

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20305774 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED DURING THE INDEX PROCEDURE. THE SUBJECT UNDERWENT TREATMENT WITH TWO RANGER PACLITAXEL-COATED PTA BALLOON CATHETERS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE LEFT MID POPLITEAL ARTERY EXTENDING TO LEFT DISTAL POPLITEAL ARTERY WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 80 MM. THE LESION WAS 100% STENOSIS AND CLASSIFIED AS TASC II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION, PRE-DILATION WAS PERFORMED USING 4 MM X 150 MM NON-BOSTON SCIENTIFIC PTA BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5 MM X 120 MM RANGER. POST-TREATMENT WAS PERFORMED BY THE PLACEMENT OF 6 MM X 80 MM NON-BOSTON SCIENTIFIC BARE METAL STENT AND DILATION USING 6 MM X 60 MM STERLING PTA BALLOON, AND THE FINAL RESIDUAL STENOSIS OF THE FIRST LESION WAS NOTED TO BE 10 PERCENT. THE SECOND TARGET LESION WAS IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 120 MM. THE LESION WAS 70% STENOSED AND CLASSIFIED AS TASC II B LESI

  Patient problems: Vascular Dissection

  MAUDE report 18277405 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY EXTENDING TO RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.0 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.0 MM WITH LESION LENGTH OF 100 MM AND 100% STENOSIS. IT WAS CLASSIFIED AS A TASC II 64B LESION. PRIOR TO TARGET LESION TREATMENT, A 5 MM X 190 MM NON-BOSTON SCIENTIFIC EMBOLIZATION PROTECTION DEVICE WAS USED, AND PRE-DILATATION WAS PERFORMED WITH A 6 MM X 100 MM NON-BOSTON SCIENTIFIC PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH STUDY DEVICE, RANGER DRUG COATED BALLOON OF 5.0 MM X 120 MM. ON THE SAME DAY OF INDEX PROCEDURE, DURING TREATMENT OF THE TARGET LESION, A GRADE C DISSECTION WAS NOTED. IN RESPONSE TO THE EVENT, A BAILOUT STENT WAS IMPLANTED, AND THE COMPLICATION WAS RESOLVED. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Vascular Dissection

  MAUDE report 13502165 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE 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 ELEGANCE 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 SUPERFICIA

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

  MAUDE report 12548653 ↗