Ranger™ H74939419502090Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729976059), received between Feb 10, 2022 and Dec 4, 2025 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED REQUIRING INTERVENTION. ON (B)(6) 2021, THE FIRST PROCEDURE OF THE RIGHT POPLITEAL ARTERY AND RIGHT SUPERFICIAL FEMORAL ARTERY WAS COMPLETED WITH TWO RANGER DRUG COATED BALLOON (DCB) CATHETERS. ON (B)(6) 2021, TARGET BLOOD VESSEL WAS GREATER THAN 50 PERCENT STENOSED, THUS PERCUTANEOUS REVASCULARIZATION WAS PERFORMED ON (B)(6) 2021, AND THE PATIENT RECOVERED.

  Patient problems: Restenosis

  MAUDE report 23716615 ↗
• MalfunctionMay 7, 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. AFTER THE 4MM WOLVERINE CUTTING BALLOON RUPTURED, A 5.0 X 200MM, 90CM RANGER DRUG-COATED BALLOON CATHETER WAS USED FOR PRE-DILATION. HOWEVER, THE BALLOON RUPTURED AS WELL DURING INITIAL INFLATION AT 6 ATMOSPHERES FOR 20 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981959 ↗
• MalfunctionDec 31, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200MM, 90CM RANGER DRUG-COATED BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 8 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, 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 21048128 ↗
• MalfunctionOct 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THIS 5.0 X 200MM, 90CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN A LOWER EXTREMITY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE 99% STENOSED, SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. DURING THE PROCEDURE, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911913 ↗
• MalfunctionJun 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THIS 5.0 X 200MM, 90CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN AN ENDOVASCULAR THERAPY PROCEDURE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATM FOR FIVE SECONDS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058530 ↗
• MalfunctionApr 7, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON CATHETER BECAME ENTRAPPED ON THE GUIDEWIRE. THIS RANGER GLOBAL DCB OTW 5.0 X 200MM, 90CM WAS SELECTED FOR USE IN A PERCUTANEOUS ANGIOPLASTY PROCEDURE. THE LESION WAS IN THE RIGHT SUPERIOR FEMORAL ARTERY, WAS SEVERELY CALCIFIED, HAD MODERATE TORTUOSITY, AND WAS 100% STENOSED. DURING THE PROCEDURE, THE BALLOON BECAME STUCK ON THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE BALLOON AND GUIDEWIRE WERE REMOVED AS ONE UNIT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY. THE PRODUCT IS NOT EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704560 ↗
• MalfunctionFeb 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 5.0MM X 200MM, 90CM RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY. THE 75% STENOSED TARGET LESION WAS MODERATELY CALCIFIED AND LOCATED IN MODERATELY TORTUOUS ANATOMY. ON THE FIRST INFLATION TO 6ATM FOR 15 SECONDS, A PINHOLE BALLOON RUPTURE OCCURRED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505378 ↗