FLEX Vessel Prep System FSC 4-40Recalls & reported problems
Venturemed Group, Inc. · FLEX Vessel Prep System, FSC 4-40 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00863656000318), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER APPLICATION WITH FLEX, A PSEUDOANEURYSM WITH CONTRAST MEDIUM LEAKAGE FORMS AFTER THE ACTUAL STENOSIS IN THE STRAIGHT SEGMENT. EVEN INSERTING AN OCCLUSION BALLOON CANNOT STOP THE BLEEDING, WHICH IS WHY SURGICAL INTERVENTION WAS NECESSARY. DURING THE OPEN PROCEDURE, THE SURGEON DESCRIBED THIS RUPTURE AS A SLIT SEVERAL CM (APPROX. 4 CM) LONG.
Patient problems: Perforation of Vessels
MAUDE report 21412984 ↗
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- AngioSculpt OTW PTA Scoring Balloon Catheter 2076-6040The Spectranetics Corporation · Catheter, Percutaneous, Cutting/Scoring17 reports
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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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