VascuTrak® V142540Recalls & reported problems
Bard Peripheral Vascular, Inc. · VascuTrak® PTA Dilatation Catheter 2.5 mm x 40 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
- 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 00801741061202), received between Feb 24, 2021 and Feb 24, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (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 18, 2026.
Most reported problems
Device problems
- Deflation Problem1
- Inflation Problem1
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.
MalfunctionFeb 24, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA IPISILATERAL ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE. THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY AND AN INFLATION WAS ATTEMPTED, BUT IT FAILED TO INFLATE AGAIN. IT SUCCESSFULLY INFLATED WHEN THE PHYSICIAN LOOSEN THE BALLOON BY HAND. HOWEVER, THE DEVICE ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11371018 ↗
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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 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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