Ranger™ H74939419500410Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729975922), received between Sep 29, 2022 and Dec 18, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERFORATION AND FISTULA OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOON AND ELUVIA DRUG-ELUTING STENTS ON (B)(6) 2021 AS PART OF THE CLINICAL TRIAL. TARGET LESION #001 WAS LOCATED IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT DISTAL SFA, AND RIGHT MID POPLITEAL ARTERY, WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 6 MM, A DISTAL REFERENCE VESSEL DIAMETER OF 5 MM, A LESION LENGTH OF 240 MM, AND 90% STENOSIS. THE LESION WAS CLASSIFIED AS A TASC II B LESION. PRIOR TO TREATMENT OF THE TARGET LESION, BALLOON DILATION WAS PERFORMED USING 4 MM X 100 MM AND 4 MM X 80 MM STERLING OTW PTA BALLOONS. TREATMENT CONSISTED OF DILATION WITH A 5 MM X 40 MM RANGER DRUG-COATED BALLOON STUDY DEVICE, FOLLOWED BY PLACEMENT OF 6 MM X 120 MM AND 6 MM X 80 MM ELUVIA DRUG-ELUTING STENT STUDY DEVICES. POST-TREATMENT DILATION WAS PERFORMED USING A 6 MM X 100 MM MUSTANG OTW PTA BALLOON, AND THE FINAL RESIDUAL STENOSIS WAS DOCUMENTED AS 0%. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. PER BASELINE CORE LAB FORM DATED (B)(6) 2021, DURING THE INDEX PROCEDURE FOR TREATMENT OF TARGET LESION #001, POST-STUDY DE

  Patient problems: Fistula; Perforation of Vessels

  MAUDE report 23839120 ↗
• MalfunctionJun 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. A 5.0 X 40MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN AN ANGIOPLASTY PROCEDURE IN THE RIGHT PROFUNDA. THE 60% TARGET LESION WAS MILDLY CALCIFIED AND LOCATED IN NON-TORTUOUS ANATOMY. AFTER ATHERECTOMY WAS PERFORMED, THE RANGER BALLOON WAS PUT IN PLACE. UPON INFLATION, THE BALLOON BURST AT 4ATM IN LESS THAN 5 SECONDS. THE BALLOON WAS TAKEN OUT AND INSPECTED. NO MISSING PIECES FROM THE BALLOON, AND THE SHAFT WAS STILL INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 6.0 X 40MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17176043 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED TARGET-LESION REVASCULARIZATION. THE SUBJECT UNDERWENT TREATMENT WITH THREE RANGER DRUG COATED BALLOONS ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL COMMON FEMORAL ARTERY AND FEMORAL-ANTERIOR TIBIAL BYPASS WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 10 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM. THE LESION WAS CLASSIFIED AS TASC II D, WITH A LENGTH OF 360 MM AND 90% STENOSIS. PRIOR TO TARGET LESION TREATMENT, BALLOON DILATATION WAS PERFORMED USING 3.0 MM X 60 MM STERLING PTA BALLOON. THE TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION USING STUDY DEVICES 5 MM X 40 MM, 6 MM X 100 MM AND 6 MM X 200 MM RANGER DRUG COATED BALLOONS. FOLLOWING POST DILATATION WAS PERFORMED WITH 7.0 MM X 220 MM STERLING PTA BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2022, 315 DAYS POST-INDEX PROCEDURE THE SUBJECT DEVELOPED WORSENING PERIPHERAL ARTERY DISEASE IN LEFT COMMON FEMORAL ARTERY. IN RESPONSE, THE LEFT COMMON FEMORAL ARTERY TO ANTERIOR TIBIAL ARTERY WAS BYPASSED WITH 6 MM RINGED PROPATEN PTFE. FOLLOWING THAT, A LEFT LOWER EXTREMITY ANGIOGRAM WAS

  Patient problems: Embolism/Embolus; Obstruction/Occlusion; Restenosis; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 15822997 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CLAUDICATION RELATED TO WORSENING ISCHEMIA OF THE TARGET VESSEL. THE SUBJECT UNDERWENT TREATMENT WITH THREE RANGER DRUG COATED BALLOONS ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL COMMON FEMORAL ARTERY AND FEMORAL-ANTERIOR TIBIAL BYPASS WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 10 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM. THE LESION WAS CLASSIFIED AS TASC II D, WITH A LENGTH OF 360 MM AND 90% STENOSIS. PRIOR TO TARGET LESION TREATMENT, BALLOON DILATATION WAS PERFORMED USING 3.0 MM X 40 MM STERLING PTA BALLOON. THE TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION USING STUDY DEVICES 5 MM X 40 MM, 6 MM X 100 MM AND 6 MM X 200 MM RANGER DRUG COATED BALLOONS. FOLLOWING POST DILATATION WAS PERFORMED WITH 7.0 MM X 220 MM STERLING PTA BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2022, SUBJECT WAS NOTED WITH THE CLAUDICATION SYMPTOMS RELATED TO WORSENING ISCHEMIA NOTED IN BILATERAL LOWER EXTREMITY. ON THE SAME DAY, SUBJECT UNDERWENT LEFT LOWER EXTREMITY DUPLEX WHICH REVEALED THAT THE LEFT EXTERNAL ILIAC ARTERY WAS PATENT, COMMON FEMORA

  Patient problems: Arteriosclerosis/ Atherosclerosis; Ischemia; Restenosis; Thrombosis/Thrombus

  MAUDE report 15506376 ↗