VascuTrak® V1850120Recalls & reported problems
Bard Peripheral Vascular, Inc. · VascuTrak® PTA Dilatation Catheter 5 mm x 120 mm, 140 cm catheter · Class 2
All models of VascuTrak (20)
Data updated Oct 18, 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 00801741061684), received between Oct 31, 2017 and Apr 24, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
- Deflation Problem1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2018Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SFA THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE. REPORTEDLY, A RE-ENTRY CATHETER WAS USED TO PUNCTURE THE BALLOON. THERE WAS NO REPORTED RETRACTION ISSUES. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7456728 ↗MalfunctionOct 31, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INFLATION HUB ALLEGEDLY BROKE DURING INSERTION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6992066 ↗
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- 2cm Peripheral Cutting Balloon® M001PCB8020900Boston Scientific Corporation · Catheter, percutaneous, cutting/scoring18 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2076-6040The Spectranetics Corporation · Catheter, Percutaneous, Cutting/Scoring17 reports
- AngioSculpt OTW PTA Scoring Balloon Catheter 2105-6040The Spectranetics Corporation · Catheter, Percutaneous, Cutting/Scoring17 reports
- ULTRASCORE US14150530Bard Peripheral Vascular, Inc. · Catheter, percutaneous, cutting/scoring15 reports
- ULTRASCORE US14150615Bard 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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