Ranger™ H74939733710020Recalls & reported problems
Boston Scientific Corporation · MONORAIL™ 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506046859), received between Oct 23, 2025 and Oct 23, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (1 report).
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
- Deflation Problem1
- Difficult to Open or Remove Packaging Material1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Deflation Problem; Stretched; Difficult to Open or Remove Packaging Material; Deflation Problem; Stretched; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT BALLOON SLOW DEFLATION OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 7.0 X 100 MM 200CM RANGER (DCB) WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE WITHDRAWING THE CATHETER FROM THE HOOP. THE GUIDEWIRE WAS SUCCESSFULLY ADVANCED TO THE LESION SITE, AND THE BALLOON WAS INFLATED. HOWEVER, DEFLATION TOOK LONGER THAN USUAL. UPON REMOVAL, THE CATHETER APPEARED ELONGATED, CONFIRMED VISUALLY AND THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23369751 ↗
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- IN.PACT™ Admiral™ ADM06004013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall12 reports
- IN.PACT™ Admiral™ ADM06015013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall11 reports
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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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