Ranger™ H74939419401080Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729975830), received between Jan 10, 2022 and Oct 15, 2025 — classified as 7 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.

• MalfunctionOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 100MM, 80CM RANGER GLOBAL DCB OTW BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT NOMINAL PRESSURE FOR 5 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289791 ↗
• MalfunctionDec 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0 X 100MM, 80CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR ENDOVASCULAR THERAPY PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 8 ATMOSPHERES FOR 3 SECONDS. 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 18315383 ↗
• MalfunctionMay 31, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON CATHETER BECAME ENTRAPPED ON THE GUIDEWIRE. THIS RANGER PACLITAXEL-COATED PTA BALLOON CATHETER 4.0 X 100MM, 80CM WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE LESION WAS IN THE LEFT SUPERIOR FEMORAL ARTERY, WAS SEVERELY CALCIFIED, HAD MODERATE TORTUOSITY, AND WAS 99% STENOSED. DURING THE PROCEDURE, THE BALLOON BECAME STUCK ON THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE BALLOON AND GUIDEWIRE WERE REMOVED AS ONE UNIT, AND ONCE OUTSIDE THE BODY, THE GUIDEWIRE WAS STILL NOT ABLE TO BE REMOVED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17033104 ↗
• MalfunctionDec 12, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON CATHETER BECAME ENTRAPPED ON THE GUIDEWIRE. A RANGER DRUG-COATED BALLOON (DCB) CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. WHILE ADVANCING OVER THE GUIDEWIRE TO THE TARGET LESION, THE BALLOON CATHETER BECAME ENTRAPPED ON THE GUIDEWIRE. BOTH GUIDEWIRE AND CATHETER WERE REMOVED TOGETHER. A NEW RANGER DCB WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960781 ↗
• MalfunctionMay 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER PACLITAXEL-COATED PTA 4.0MM X 100MM X 80CM BALLOON CATHETER WAS SELECTED FOR USE TO TREAT SUPERFICIAL FEMORAL ARTERY STENOSIS FOR ENDOVASCULAR THERAPY. THE PROCEDURE WAS BEING PERFORMED TO TREAT 95% STENOSIS, AND THE TARGET LESION CONTAINED SEVERE 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 TWO SECONDS. THE CATHETER WAS REMOVED AS INTENDED WITH NO VISUAL OBSERVATION OF DAMAGE TO THE BALLOON. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING ANOTHER RANGER DEVICE WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399499 ↗
• MalfunctionFeb 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PINHOLE BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0X100MM, 80CM RANGER DRUG-COATED BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS DURATION TIME, THE BALLOON RUPTURED. AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13475394 ↗
• MalfunctionJan 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. PRE-DILATION WAS PERFORMED WITH A 4MM BALLOON, AND A 4.0 X 100MM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST DILATION THE BALLOON WAS INFLATED TO 4 ATMOSPHERES FOR 10 SECONDS, AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204928 ↗