Ranger™ H74939419602090Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729976219), received between May 14, 2021 and Sep 8, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Material 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 6.0 X 200MM, 90CM RANGER BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, 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 22994896 ↗
• MalfunctionOct 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200MM, 90CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, ON THE FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND REPLACED FOR ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358909 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT EXPERIENCED MYOSITIS REPORTED TO BE CAUSED BY PACLITAXEL TREATMENT. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED LOWER LIMB PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY FOR PERIPHERAL ARTERIAL DISEASE. THE TARGET LESION WAS REPORTED AS 100% STENOSED WITH MILD TORTUOSITY AND MODERATE SEVERITY. THE PATIENT WAS RETURNING A FEW WEEKS LATER FOR AN ADDITIONAL TREATMENT OF THE IPSILATERAL ILIAC CASE THAT WAS NOT TREATED PREVIOUSLY; HOWEVER, THE PATIENT REPORTED VERY SEVERE PAIN IN THE LEG (ESPECIALLY BELOW THE POPLITEAL FOSSA) AND THE MUSCLE DEVIATION ENZYME HAD INCREASED UP TO 2 SINCE THE LAST PROCEDURE. IT WAS CONSIDERED THAT IT MIGHT BE A COMPARTMENT SYNDROME, BUT AFTER A CONSULTATION WITH A PLASTIC SURGEON, IT WAS DIFFERENT. THEY PHYSICIAN REPORTED THAT THE SYMPTOMS OF MYOSITIS WAS CONSIDERED TO BE CAUSED BY PACLITAXEL. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND 5L REPLACEMENT FLUID AS TREATMENT.

  Patient problems: Inflammation; Pain

  MAUDE report 17293395 ↗
• MalfunctionJul 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER, 6.0 X 200MM, 90CM WAS SELECTED FOR USE IN THE ENDOVASCULAR THERAPY PROCEDURE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS 99% STENOSED WITH MODERATE TORTUOSITY AND CALCIFICATION. THE RANGER WAS ADVANCED TO THE TARGET LESION AND INFLATED ONCE TO 12 ATM FOR 10 SECONDS BEFORE THE BALLOON RUPTURED. THE RANGER WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND REPLACED WITH ANOTHER RANGER PACLITAXEL-COATED PTA BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES FOR THE PATIENT, AND THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17247120 ↗
• MalfunctionNov 21, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PINHOLE RUPTURE IN THE BALLOON. A RANGER GLOBAL DCB OTW 6.0 X 200MM, 90CM WAS SELECTED FOR USE IN THE ENDOVASCULAR THERAPY (EVT) PROCEDURE. THE TARGET LESION WAS WITHIN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS REPORTED TO BE 100% STENOSED WITH MODERATE CALCIFICATION. THE RANGER WAS ADVANCED TO THE TARGET LESION AND INFLATED FOR THE FIRST TIME TO 6 ATM BEFORE BURSTING. THE FORM OF THE RUPTURE WAS REPORTED TO BE A PINHOLE. THE DEVICE WAS RETRACTED WITHOUT ISSUE. THE RANGER WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15840166 ↗
• MalfunctionJul 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER DRUG-COATED BALLOON CATHETER 6.00MM X 200MM, 90CM WAS SELECTED FOR USE TO TREAT SUPERFICIAL FEMORAL ARTERY STENOSIS FOR ENDOVASCULAR THERAPY. THE PROCEDURE WAS BEING PERFORMED TO TREAT 100% STENOSIS, AND THE TARGET LESION CONTAINED MODERATE CALCIFICATION AND MODERATE TORTUOUS SEVERITY. THE PHYSICIAN INSERTED THE CATHETER, AND UPON TREATMENT OF THE AREA THE BALLOON RUPTURED WITH A SINGLE INFLATION AT 6 ATM FOR 10 SECONDS. THE CATHETER WAS REMOVED AS INTENDED, AND IT WAS OBSERVED THAT THERE WAS A VERTICAL RUPTURE ON THE DISTAL SIDE. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING ANOTHER RANGER DEVICE WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065146 ↗
• MalfunctionSep 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 6.0 X 200MM, 90CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR A PATIENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT WAS BEING TREATED FOR PERIPHERAL ARTERY DISEASE. THE LESION WAS MODERATELY TORTUOUS, 100% STENOSED, AND SEVERELY CALCIFIED. DURING THE PROCEDURE, INSIDE OF THE PATIENT, THE BALLOON RUPTURED AT 10 ATM. THE DEVICE WAS REMOVED WITHOUT PROBLEMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408897 ↗
• MalfunctionMay 14, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED POST-SEDATION. A 6MM X 200MM, 90CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN A PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY. THE 95% STENOSED TARGET LESION WAS MODERATELY CALCIFIED AND LOCATED IN MODERATELY TORTUOUS ANATOMY. DURING THE PROCEDURE, THE RANGER DEVICE WAS UNABLE TO ADVANCE THROUGH A NON-BOSTON SCIENTIFIC GUIDE CATHETER. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11827642 ↗