ULTRASCORE US14150230Recalls & reported problems
Bard Peripheral Vascular, Inc. · ULTRASCORE™ Focused Force PTA Balloon 2mm x 300mm, 150cm catheter · Class 2
All models of ULTRASCORE (61)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741113352), received between Apr 8, 2020 and Apr 8, 2020 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL STUDY TRIAL, A FOCUSED FORCE PTA BALLOON WAS USED TO TREAT THE LEFT FEMORAL ARTERY, APPROXIMATELY 5-MONTHS AND 27DAYS THE PATIENT EXPERIENCED 100% STENOSIS OF TARGET LESION AND REVASCULARIZATION WAS PERFORMED. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.
Patient problems: Stenosis
MAUDE report 9933770 ↗
Other Catheter, percutaneous, cutting/scoring devices
- AngioSculpt OTW PTA Scoring Balloon Catheter 2092-6040The Spectranetics Corporation · Catheter, Percutaneous, Cutting/Scoring41 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2076-5040The Spectranetics Corporation · Catheter, Percutaneous, Cutting/Scoring31 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2092-5040The Spectranetics Corporation · Catheter, Percutaneous, Cutting/Scoring28 reports
- 2cm Peripheral Cutting Balloon® M001PCB8020900Boston Scientific Corporation · Catheter, percutaneous, cutting/scoring18 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2105-6040The Spectranetics Corporation · Catheter, Percutaneous, Cutting/Scoring17 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2076-6040The Spectranetics Corporation · Catheter, Percutaneous, Cutting/Scoring17 reports
- ULTRASCORE US14150530Bard Peripheral Vascular, Inc. · Catheter, percutaneous, cutting/scoring15 reports
- ULTRASCORE US3513058Bard Peripheral Vascular, Inc. · Catheter, percutaneous, cutting/scoring14 reports
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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