Ranger™ H74939419500810Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729975960), received between Sep 29, 2021 and Sep 18, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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.

• InjurySep 18, 2026Break; Nonstandard Device; Difficult to Remove; Material Rupture; Failure to Deflate

  It was reported that balloon rupture, catheter separation, and removal difficulty occurred requiring additional intervention.The 100% stenosed target lesion was located in the severely calcified superficial femoral artery. The lesion was successfully crossed and pre-dilated using a Sterling balloon (size unknown). An Eluvia stent was then deployed in the lesion. Subsequently, a 5.0 x 80mm, 135cm Ranger Drug Coated balloon was used to treat a more distal popliteal lesion. During a subsequent inflation within the newly placed Eluvia stent, the Ranger balloon ruptured on the second inflation. The entire catheter shaft was also broken. Following the rupture, the physician experienced significant difficulty retracting the damaged device through the stent, lesion, and sheath. Because the balloon had ruptured, vacuum could not be maintained, and complete deflation could not be confirmed. A snare was required to retrieve the damaged balloon catheter from the patient. The device was removed successfully, and no fragments were reported to have remained in the patient. Upon removal, severe physical damage was noted and was described as being in a "curly-q" configuration. The procedure was com

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820244 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOON AND ELUVIA DRUG ELUTING STENTS AS PART OF CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY AND LEFT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 100 MM LESION LENGTH WITH 90 % STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II C LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 80 MM RANGER DRUG COATED BALLOON AND PLACEMENT OF 6 MM X 60 MM AND 6 MM X 40 MM ELUVIA DRUG ELUTING STENTS, STUDY DEVICE. POST TREATMENT WAS PERFORMED BY DILATION OF MUSTANG PTA BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2023, ON THE SAME DAY OF INDEX PROCEDURE, DURING THE TREATMENT OF TARGET LESION #001, DISSECTION OF GRADE E WAS NOTED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY DUE TO 5 MM X 80 MM RANGER DRUG-COATED BALLOON. IN RESPONSE TO THE COMPLICATION, ELUVIA STENT WAS PLACED AS A BAILOUT STENT, AN

  Patient problems: Vascular Dissection

  MAUDE report 22035945 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY: IT WAS REPORTED THAT THE SUBJECT HAD RE-OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY AND LEFT POPLITEAL ARTERY, REQUIRING INTERVENTION. THE SUBJECT WAS ENROLLED IN THE ELEGANCE CLINICAL STUDY ON (B)(6) 2022. BASELINE RUTHERFORD CLASSIFICATION ASSESSMENT WAS PERFORMED ON THE SAME DAY AND REVEALED CATEGORY 4 ISCHEMIC REST PAIN. THE INDEX PROCEDURE WAS ALSO PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID-SFA, LEFT DISTAL SFA, LEFT PROXIMAL POPLITEAL ARTERY EXTENDING UP TO THE LEFT MID-POPLITEAL ARTERY, WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 470 MM WITH 100% STENOSIS, AND WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO TREATMENT OF THE TARGET LESION WITH THE STUDY DEVICES, DILATION WAS PERFORMED USING A NON-BOSTON SCIENTIFIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON, AND LASER TREATMENT WITH A NON-BOSTON SCIENTIFIC LASER DEVICE. THEN TREATMENT OF THE TARGET LESION WAS PERFORMED USING THREE RANGER PACLITAXEL-COATED PTA BALLOON CATHETERS: SIZES 5 MM X 200 MM, 5 MM X 200 MM AND 5

  Patient problems: Arteriosclerosis/ Atherosclerosis; Discomfort; Obstruction/Occlusion

  MAUDE report 17619352 ↗
• MalfunctionSep 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A PTA 5.0MM X 80MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE TO TREAT THE OSTIAL SUPERFICIAL FEMORAL ARTERY STENOSIS FOR PERIPHERAL ARTERIAL DISEASE. THE PROCEDURE WAS BEING PERFORMED TO TREAT 100% STENOSIS, AND THE TARGET LESION CONTAINED CALCIFICATION AND SEVERE TORTUOSITY. THE PHYSICIAN INSERTED THE CATHETER, AND UPON TREATMENT OF THE AREA, THE BALLOON RUPTURED WITH A SINGLE INFLATION FOR 5-10 SECONDS. THE CATHETER WAS REMOVED AS INTENDED WITH NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING A 5MM X 60MM X 135MM RANGER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414203 ↗
• 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 25-JAN-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; High Blood Pressure/ Hypertension; Ischemia; Obstruction/Occlusion

  MAUDE report 14646800 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 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 SUPERFICIAL

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

  MAUDE report 12548651 ↗