Ranger™ H74939419700610Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729976264), received between May 4, 2021 and Mar 31, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 18, 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.

• MalfunctionMar 31, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7.0 X 60MM, 135CM RANGER DRUG COATED BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 4 ATMOSPHERES FOR 8 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745162 ↗
• MalfunctionJun 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7.0 X 60MM, 135CM RANGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR APPROXIMATELY 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210126 ↗
• MalfunctionSep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WITH A STRAIGHT VASCULAR CHARACTERISTIC LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED AROUND LEFT COMMON FEMORAL ARTERY AND SUPERFICIAL FEMORAL ARTERY. THE PRE-DILATION WAS PERFORMED USING A 7X40 NON-BOSTON SCIENTIFIC BALLOON. A 7.0 X 60MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE AND WAS ADVANCED THROUGH SHEATH WITH THE USE OF THE LOADING TOOL. DURING THE PROCEDURE, THE BALLOON RUPTURED IMMEDIATELY AFTER DILATION BEGAN UPON INITIAL INFLATION AT AROUND 10 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, 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 20263736 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL IT WAS REPORTED ISCHEMIA OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOON AND ELUVIA DRUG-ELUTING STENTS ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE LEFT EXTERNAL ILIAC ARTERY WITH 6MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.5MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 60MM WITH 70% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 7MM X 60MM RANGER DRUG-COATED BALLOON STUDY DEVICE. FOLLOWING POST-TREATMENT WAS PERFORMED BY PLACEMENT OF 9MM X 60MM EPIC VASCULAR SELF-EXPANDING STENT AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON THE THIRD DAY OF (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT VISITED THE HOSPITAL, COMPUTED TOMOGRAPHY ANGIOGRAPHY RUNOFF SHOWED SIGNIFICANT STENOSIS IN THE LEFT DISTAL EXTERNAL ILIAC ARTERY (EIA) STENT. HOWEVER, NO ACTION WAS TAKEN AT THAT POINT OF TIME. ON (B)(6) 2023, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR REINTERVENTION OF LEFT LOWER EXTREMITY PERIPHERAL ARTERIAL OCCLUSIVE DISEASE. THE SUBJECT WA

  Patient problems: Ischemia; Restenosis

  MAUDE report 18378679 ↗
• MalfunctionMar 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY PROCEDURE TO TREAT PERIPHERAL ARTERIAL DISEASE OF THE SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN INSERTED THE CATHETER, AND UPON TREATMENT THE BALLOON RUPTURED AFTER 5 SECOND INFLATION AT 6 ATM. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING ANOTHER DRUG-COATED BALLOON WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554749 ↗
• MalfunctionMay 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 7.0MM X 60MMN, 135CM RANGER DRUG COATED BALLOON (DCB) WAS SELECTED FOR USE FOR A PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE (PAD) IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE FIRST INFLATION AT 10 ATMOSPHERES, AND WITHIN ONE MINUTE, THE BALLOON RUPTURED. A PINHOLE WAS NOTED ON THE BALLOON. THE DEVICE WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770020 ↗