Ranger™ H74939419701010Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729976301), received between Apr 16, 2021 and Jun 23, 2025 — classified as 9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 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 7.0 X 100MM, 135CM RANGER GLOBAL DCB OTW BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES. 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 22308265 ↗
• MalfunctionDec 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7.0 X 100MM, 135CM RANGER DRUG-COATED 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. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035610 ↗
• MalfunctionJul 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 60 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 19818322 ↗
• MalfunctionApr 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THIS RANGER GLOBAL DCB OTW 7.0 X 100MM, 135CM WAS SELECTED FOR USE IN AN ENDOVASCULAR THERAPY PROCEDURE. THE LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS 99% STENOSED, MILDLY TORTUOUS, AND MODERATELY CALCIFIED. IT WAS NOTED THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS ABLE TO BE REMOVED, THE PROCEDURE WAS COMPLETED WITH A DIFFERENT RANGER BALLOON, AND THERE WAS NO PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820268 ↗
• MalfunctionMar 22, 2023Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON WAS STUCK ON THE GUIDEWIRE. THIS RANGER GLOBAL DCB OTW 7.0 X 100MM, 135CM WAS SELECTED FOR USE IN A PERCUTANEOUS ANGIOPLASTY PROCEDURE. THE LESION WAS IN THE SUPERIOR FEMORAL ARTERY (SFA), WAS SEVERELY CALCIFIED, HAD MODERATE TORTUOSITY, AND WAS 90 PERCENT STENOSED. DURING THE PROCEDURE, THE BALLOON BECAME STUCK ON THE NON-BSC GUIDEWIRE. THE BALLOON AND GUIDEWIRE WERE REMOVED AS ONE UNIT; HOWEVER, IT WAS NOTED THAT IT WAS NOT SMOOTH WHEN THE DEVICE WAS REMOVED FROM THE SHEATH. THERE WAS NO PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590307 ↗
• MalfunctionJan 4, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER WAS STUCK ON THE GUIDEWIRE. A RANGER DRUG-COATED BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE TARGET LESION WAS 99% STENOSE, SEVERELY TORTUOUS AND SEVERELY CALCIFIED AND LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE BALLOON CATHETER BECAME ENTRAPPED ON A NON-BSC GUIDEWIRE. THE DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095657 ↗
• MalfunctionAug 19, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME ENTRAPPED ON THE GUIDEWIRE. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 7.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR THE PERCUTANEOUS ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE, HOWEVER, THE BALLOON CATHETER BECAME ENTRAPPED ON THE NON-BSC GUIDEWIRE. THE CATHETER AND THE GUIDEWIRE HAD TO BE REMOVED TOGETHER. A DIFFERENT DEVICE OF A DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258907 ↗
• MalfunctionMay 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7.0 X 100MM, 135CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR THE ENDOVASCULAR THERAPY PROCEDURE. DURING THE FIRST INFLATION AT 6 ATMOSHPERES FOR 5 SECONDS DURATION TIME, THE BALLOON RUPTURED. AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459187 ↗
• MalfunctionApr 16, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED A BALLOON HAD BEEN DIFFICULT TO REMOVE. A PROCEDURE WAS BEING PERFORMED WITH A 7 X 100 RANGER DRUG COATED BALLOON. POST INFLATION OF THE BALLOON, THE PHYSICIAN HAD DIFFICULTY IN REMOVING IT. THE PHYSICIAN WAS ABLE TO PULL THE BALLOON INTO THE SHEATH AND THEN REMOVE THE SHEATH AND BALLOON TOGETHER. NO COMPLICATIONS OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678524 ↗