Ranger™ H74939419600410Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729976080), received between Sep 19, 2022 and Sep 3, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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 18, 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.

• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that restenosis occurred requiring additional intervention.The target lesion was located in the right arm AV fistula outflow vein (basilic vein). On Mar. 31, 2026, two Ranger Paclitaxel-Coated PTA Balloon Catheters were selected for use in a clinical study: a 6.0 x 40 mm, 135 cm Ranger balloon, which was inflated once at 9 atmospheres for 150 seconds, and a 5.0 x 40 mm, 135 cm Ranger balloon, which was inflated once at 8 atmospheres for 150 seconds. On (b)(6), 2026, restenosis of the right AV fistula outflow vein occurred, and the patient underwent an angioplasty procedure. On (b)(6), 2026, the event was considered resolved.

  Patient problems: Restenosis

  MAUDE report 50587895 ↗
• MalfunctionMay 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED VIA A GOOD LABORATORY PRACTICE (GLP) STUDY THAT STERILITY WAS COMPROMISED DUE TO DAMAGED DEVICE PACKAGING. ONE 7.0 X 40MM, 135CM RANGER DRUG-COATED BALLOON (DCB) WAS REMOVED FROM THE COMMERCIAL LABELED BOX TO INTRODUCE TO AN ANIMAL SUBJECT. UPON REMOVAL AND PRIOR TO USE, HOWEVER, IT WAS OBSERVED THAT THE INNER PACKAGE WAS PUNCHED, MAKING THE DEVICE UNSTERILE AND UNUSABLE. AFTER THIS OBSERVATION, THE REST OF THE REMAINING UNUSED RANGER DCBS WERE INSPECTED PRIOR TO USE. IN ADDITION TO THE FIRST RANGER DCB, FOUR MORE RANGER DCBS WERE ALSO IDENTIFIED TO HAVE DAMAGED INNER PACKAGING. THERE WERE 3 FROM LOT 2440H24 AND 2 FROM LOT 04347H24. THE DEVICES WERE NOT USED IN THE GLP STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106964 ↗
• MalfunctionMay 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED VIA A GOOD LABORATORY PRACTICE (GLP) STUDY THAT STERILITY WAS COMPROMISED DUE TO DAMAGED DEVICE PACKAGING. ONE 7.0 X 40MM, 135CM RANGER DRUG-COATED BALLOON (DCB) WAS REMOVED FROM THE COMMERCIAL LABELED BOX TO INTRODUCE TO AN ANIMAL SUBJECT. UPON REMOVAL AND PRIOR TO USE, HOWEVER, IT WAS OBSERVED THAT THE INNER PACKAGE WAS PUNCHED, MAKING THE DEVICE UNSTERILE AND UNUSABLE. AFTER THIS OBSERVATION, THE REST OF THE REMAINING UNUSED RANGER DCBS WERE INSPECTED PRIOR TO USE. IN ADDITION TO THE FIRST RANGER DCB, FOUR MORE RANGER DCBS WERE ALSO IDENTIFIED TO HAVE DAMAGED INNER PACKAGING. THERE WERE 3 FROM LOT 2440H24 AND 2 FROM LOT 04347H24. THE DEVICES WERE NOT USED IN THE GLP STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106959 ↗
• MalfunctionMay 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED VIA A GOOD LABORATORY PRACTICE (GLP) STUDY THAT STERILITY WAS COMPROMISED DUE TO DAMAGED DEVICE PACKAGING. ONE 7.0 X 40MM, 135CM RANGER DRUG-COATED BALLOON (DCB) WAS REMOVED FROM THE COMMERCIAL LABELED BOX TO INTRODUCE TO AN ANIMAL SUBJECT. UPON REMOVAL AND PRIOR TO USE, HOWEVER, IT WAS OBSERVED THAT THE INNER PACKAGE WAS PUNCHED, MAKING THE DEVICE UNSTERILE AND UNUSABLE. AFTER THIS OBSERVATION, THE REST OF THE REMAINING UNUSED RANGER DCBS WERE INSPECTED PRIOR TO USE. IN ADDITION TO THE FIRST RANGER DCB, FOUR MORE RANGER DCBS WERE ALSO IDENTIFIED TO HAVE DAMAGED INNER PACKAGING. THERE WERE 3 FROM LOT 2440H24 AND 2 FROM LOT 04347H24. THE DEVICES WERE NOT USED IN THE GLP STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106808 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY. IT WAS REPORTED THAT A VESSEL DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON (B)(6) 2023 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 INTO RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 6.2 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.3 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 200 MM WITH 100 % STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 5 MM X 200 MM NON-BOSTON SCIENTIFIC (BSC) BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICES, 6 MM X 200 MM, 6 MM X 150 MM AND 6 MM X 40 MM RANGER DRUG-COATED BALLOONS. FOLLOWING TREATMENT WAS PERFORMED BY PLACEMENT OF 7 MM X 150 MM AND 7 MM X 100 MM INNOVA BARE METAL STENTS FOLLOWED BY DILATION WITH 6 MM X 80 MM NON-BSC BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON (B)(6) 2023, ON THE SAME DAY OF INDEX PROCEDURE, DURING THE TREATMENT OF THE TARGET LESION, DISSECTION OF GRADE B WAS NOTED IN THE TARGET LESION, AND THE SITE HAS C

  Patient problems: Vascular Dissection

  MAUDE report 17618621 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A VESSEL DISSECTION. AN ADDITIONAL DEVICE WAS REQUIRED TO TREAT THE DISSECTION. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENTS AND RANGER DRUG-COATED BALLOONS ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY, LEFT DISTAL SUPERFICIAL FEMORAL ARTERY, LEFT PROXIMAL POPLITEAL ARTERY AND LEFT MID POPLITEAL ARTERY WITH 6.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 480 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICES, LASER ATHERECTOMY WAS PERFORMED USING 1.5 MM NON-BOSTON SCIENTIFIC OTW DEVICE, PRE-DILATION WAS PERFORMED USING 3 MM X 100 MM AND 6 MM X 240 MM NON-BOSTON SCIENTIFIC OTW PTA BALLOON AND TWO 6 MM X 60 MM MUSTANG PTA BALLOONS. TREATMENT OF TARGET LESION WAS PERFORMED BY THE PLACEMENT OF STUDY DEVICES OF SIZE 7 MM X 120 MM AND 7 MM X 150 MM ELUVIA DRUG ELUTING STENTS AND DILATION USING STUDY DEVICES, TWO 6 MM X 200 MM AND ONE 6 MM X 40 MM OF RANGER DRUG-COATED BALLOONS. POST TREATMENT OF TARG

  Patient problems: Vascular Dissection

  MAUDE report 17397715 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLAUDICATION OCCURRED REQUIRING SURGICAL INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOON ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROFUNDA FEMORAL ARTERY WITH 6.00 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.00 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 20 MM WITH 90% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED WITH A NON-BOSTON SCIENTIFIC ATHERECTOMY DEVICE. THE TREATMENT OF THE TARGET LESION WAS PERFORMED BY DILATATION USING STUDY DEVICE 6 MM X 40 MM, RANGER DRUG COATED BALLOON. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON DAPT. ON (B)(6) 2022, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO CLAUDICATION OF LEFT LOWER EXTREMITY. IN RESPONSE TO EVENT, SUBJECT UNDERWENT TARGET LESION REVASCULARIZATION.

  Patient problems: Arteriosclerosis/ Atherosclerosis

  MAUDE report 15451401 ↗