Ranger™ H74939733610020Recalls & reported problems
Boston Scientific Corporation · MONORAIL™ Paclitaxel-Coated PTA Balloon Catheter · Class 3
All models of Ranger (50)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506046781), received between Apr 13, 2026 and Sep 21, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Material Rupture
It was reported that balloon rupture occurred. The 90% stenosed target lesion was located in the moderately tortuous superficial femoral artery (SFA). A 6.0 x 100 mm 200 cm Ranger Drug-Coated Balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon first inflation at nominal atmospheres. The device was removed without any problem using the normal method, 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's condition was satisfactory after the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839500 ↗MalfunctionApr 13, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 6.0 X 100 MM 200CM RANGER DRUG COATED BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 15 SECONDS. 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 24854133 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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