Ranger™ H74939419600680Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729976110), received between May 18, 2021 and Dec 10, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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.

• MalfunctionDec 10, 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 60 MM, 80 CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 23772911 ↗
• MalfunctionApr 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THIS RANGER GLOBAL DCB OTW 6.0 X 60MM, 80CM WAS SELECTED FOR USE IN AN ENDOVASCULAR THERAPY PROCEDURE. THE LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS 40% STENOSED AND MILDLY CALCIFIED. IT WAS NOTED THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 3 ATMOSPHERES. THE DEVICE WAS ABLE TO BE REMOVED, THE PROCEDURE WAS COMPLETED WITH A DIFFERENT RANGER BALLOON, AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820348 ↗
• MalfunctionOct 26, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BALLOON WAS RUPTURED. DURING THE ENDOVASCULAR THERAPY FOR SEVERE LOWER LIMB ISCHEMIA IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE. THE TARGET LESION IN THE SFA WAS 99% STENOSED WITH SEVERE CALCIFICATION AND TORTUOSITY. THE RANGER WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 10 ATM OF PRESSURE. THE BALLOON RUPTURED VERTICALLY AFTER 10 SECONDS OF INFLATION. THE BALLOON AND DELIVERY SYSTEM WERE REMOVED WITHOUT ISSUE. THE RANGER WAS REPLACED WITH ANOTHER RANGER AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15673640 ↗
• MalfunctionSep 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 60MM, 80CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED TO TREAT THE SEVERE LIMB ISCHEMIA IN THE ENDOVASCULAR TREATMENT PROCEDURE. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 2 SECONDS DURATION, THE BALLOON RUPTURED VERTICALLY. AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15341922 ↗
• MalfunctionDec 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY ENDOVASCULAR THERAPY PROCEDURE. THE PROCEDURE WAS BEING PERFORMED TO TREAT 99% STENOSIS. 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 30 SECONDS. THE CATHETER WAS REMOVED AS INTENDED WITH NO VISUAL OBSERVATION OF DAMAGE TO THE BALLOON. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960921 ↗
• MalfunctionSep 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LEFT SUPERFICIAL FEMORAL ARTERY WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. A RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS ADVANCED AND INFLATED ONCE TO A PRESSURE OF 8 ATMOSPHERES FOR 20 SECONDS. THE BALLOON RUPTURED AND A PINHOLE WAS NOTED. THE RANGER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON BOSTON SCIENTIFIC DEVICE. THE PATIENT IS IN GOD CONDITION WITH NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510002 ↗
• MalfunctionSep 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE HAD OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A 90% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 6.0 X 60MM RANGER PACLITAXEL-COATED PERIPHERAL TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER RUPTURED ON THE FIRST INFLATION AT 6 ATMOSPHERES. THE RUPTURE WAS NOTED TO THE PROXIMAL SIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12501873 ↗
• MalfunctionMay 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0MMX60MM X 80CM RANGER DRUG COATED BALLOON WAS SELECTED FOR USE FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE FIRST INFLATION, THE BALLOON WAS INFLATED TO 12 ATMOSPHERES AND IT RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11840900 ↗