VascuTrak® V1850100Recalls & reported problems
Bard Peripheral Vascular, Inc. · VascuTrak® PTA Dilatation Catheter 5 mm x 100 mm, 140 cm catheter · Class 2
All models of VascuTrak (20)
Data updated Oct 16, 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 00801741061677), received between Apr 30, 2018 and Mar 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 Contamination with Chemical or Other Material1
- Material Puncture/Hole1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2025Material Puncture/Hole; Device Contamination with Chemical or Other Material; Material Puncture/Hole; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY EXPOSED ON THE OUTSIDE OF THE PTA BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21557339 ↗MalfunctionApr 30, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7474423 ↗
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- 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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