Ranger™ H74939419401010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729975823), received between Mar 16, 2023 and Aug 14, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain in the left lower extremity.On (b)(6)2022, the patient underwent treatment of a target lesion in the mid-to-distal superficial femoral artery using a 4.0 x 100 mm, 135 cm Ranger Drug-Coated Balloon. The balloon was inflated to 8 atmospheres for 180 seconds. On (b)(6)2024, the patient experienced pain in the left lower extremity involving calf and radiating to foot. Additional intervention was performed using drug-coated balloon (DCB) angioplasty and balloon angioplasty. The event subsequently resolved on (b)(6)2025.

  Patient problems: Pain

  MAUDE report 50255881 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED GANGRENE OF RIGHT FOOT OCCURRED REQUIRING INTERVENTION. THE SUBJECT WAS ENROLLED IN A CLINICAL STUDY ON (B)(6) 2024. THE TARGET LESION WAS TREATED WITH A 4.0 X 100MM, 135CM RANGER DRUG-COATED BALLOON FOLLOWED BY A 5.0 X 150MM, 150 CM RANGER DRUG-COATED BALLOON. THE 4.0 X 100MM, 135CM RANGER WAS INFLATED ONCE TO A MAXIMUM INFLATION PRESSURE 16 ATMOSPHERES FOR 180 SECONDS. THE 5.0 X 150MM, 150 CM RANGER WAS INFLATED ONCE TO A MAXIMUM INFLATION PRESSURE 14 ATMOSPHERES FOR 180 SECONDS. ON (B)(6) 2025, THE SUBJECT PRESENTED WITH GANGRENE OF THE RIGHT FOOT. THE SUBJECT WAS HOSPITALIZED, AND ON (B)(6) 2025, AMPUTATION WAS PERFORMED. ON (B)(6) 2025, THE ISSUE WAS CONSIDERED RESOLVED. THE SUBJECT WAS DISCHARGED ON (B)(6) 2025.

  Patient problems: Necrosis

  MAUDE report 24314542 ↗
• MalfunctionJan 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 100MM, 135CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR ABOUT 1 MINUTE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21279803 ↗
• InjuryAug 8, 2024Adverse 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 OCCLUSION OF THE RIGHT POPLITEAL ARTERY, REQUIRING INTERVENTION. ON (B)(6) 2022, THE SUBJECT UNDERWENT TREATMENT WITH 4.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESIONS WERE IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT MID-SFA, RIGHT DISTAL SFA, RIGHT PROXIMAL POPLITEAL ARTERY, AND THE RIGHT MID-POPLITEAL ARTERY EXTENDING UP TO THE RIGHT DISTAL POPLITEAL ARTERY WITH 5MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4MM DISTAL REFERENCE VESSEL DIAMETER, WITH A LESION LENGTH OF 450 MM AND 100% STENOSIS. PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED WITH A NON-BOSTON SCIENTIFIC (BSC) LASER ATHERECTOMY DEVICE, FOLLOWED BY PRE-DILATION USING TWO NON-BSC BALLOONS. TREATMENT OF THE TARGET LESION WAS THEN PERFORMED BY DILATION USING 5 MM X 200 MM, 5 MM X 200 MM, AND 4 MM X 100 MM RANGER DRUG COATED BALLOON STUDY DEVICES. POST DILATATION TREATMENT WAS PERFORMED WITH A NON-BSC CUTTING BALLOON, AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2022, ON THE DAY OF DISCHARGE, THE SUBJECT COMPLAINED OF

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

  MAUDE report 19938374 ↗
• MalfunctionMay 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES FOR A FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234431 ↗
• MalfunctionFeb 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703904 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SYMPTOMS OF LEFT LOWER EXTREMITY ISCHEMIA AND NEW ULCERS ON THE 1ST AND 3RD TOES, REQUIRING HOSPITALIZATION, MEDICAL INTERVENTION AND MEDICATION, AND AMPUTATION. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT FEMORAL-PERONEAL BYPASS AND LEFT PERONEAL ARTERY WITH 4.00 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.00 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 100 MM WITH 90% STENOSIS. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATATION WAS PERFORMED USING 3.5 MM X 150 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION USING STUDY DEVICE OF SIZE 4 MM X 100 MM RANGER DRUG-COATED BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED FORM HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2022, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO LEFT LOWER EXTREMITY ISCHEMIA. ON (B)(6) 2022, TARGET LESION REVASCULARIZATION WAS ATTEMPTED, BUT IT WAS UNSUCCESSFUL. ON (B)(6) 2022, THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREAT

  Patient problems: Ischemia; Obstruction/Occlusion; Restenosis; Ulcer; Unspecified Tissue Injury

  MAUDE report 16559470 ↗