Ranger™ H74939419501080Recalls & reported problems
Boston Scientific Corporation · Paclitaxel-Coated PTA Balloon Catheter · Class 3
All models of Ranger (50)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729975991), received between May 16, 2023 and Oct 16, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (4 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0MM X 100MM, 80CM RANGER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER WAS SELECTED FOR USE IN AN ENDOVASCULAR TREATMENT. DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23309411 ↗MalfunctionMar 27, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0 X 100MM, 80CM RANGER DRUG-COATED BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 10 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, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21708884 ↗MalfunctionFeb 20, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100MM, 80CM RANGER PACLITAXEL-COATED PTA BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATM FOR 10 SECONDS. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 18742101 ↗MalfunctionMay 16, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT THE BALLOON RUPTURED. THIS RANGER GLOBAL DCB OTW 5.0 X 100MM, 80CM WAS SELECTED FOR USE IN AN ENDOVASCULAR THERAPY PROCEDURE. THE LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS 90% STENOSED, MODERATELY TORTUOUS, AND SEVERELY CALCIFIED. THE FIRST BALLOON INFLATION WAS AT 6 ATMOSPHERES FOR THREE MINUTES. THE PRESSURE AT THE TIME OF BALLOON RUPTURE WAS AT 8 ATMOSPHERES. THE DEVICE WAS ABLE TO BE REMOVED WITHOUT PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER RANGER BALLOON. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16940638 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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