ULTRASCORE US3513074Recalls & reported problems
Bard Peripheral Vascular, Inc. · ULTRASCORE™ Focused Force PTA Balloon 7mm x 40mm, 130cm catheter · Class 2
All models of ULTRASCORE (61)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741116940), received between Apr 1, 2024 and Jul 27, 2026 — classified as 3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Burst Container or Vessel1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Material Rupture
On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty (PTA) procedure using the UltraScore 035 balloon catheter. During the procedure, the balloon catheter allegedly ruptured. The procedure was completed using another balloon. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50021295 ↗MalfunctionMar 31, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED IN THE BACK PART. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21729005 ↗MalfunctionApr 1, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A HOLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011452 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page