ULTRASCORE US1415052Recalls & reported problems
Bard Peripheral Vascular, Inc. · ULTRASCORE™ Focused Force PTA Balloon 5mm x 20mm, 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741113918), received between Dec 11, 2023 and Dec 11, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
- Difficult to Advance1
- Difficult to Insert1
- Difficult to Remove1
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.
MalfunctionDec 11, 2023Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Difficult to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY DOES NOT FIT INTO THE SHEATH AND HAD DIFFICULTY TO INSERT INTO THEM. REPORTEDLY, THE BALLOON WAS ALLEGEDLY DIFFICULT TO BE PULLED OUT OF THE SHEATH AND NEEDED TO REMOVE THE SHEATH WITH THE BALLOON STUCK IN IT. THERE WERE NOT REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18299926 ↗
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- 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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