FLEX Vessel Prep System FSC 4-75Recalls & reported problems
Venturemed Group, Inc. · FLEX Vessel Prep System, FSC 4-75 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00863656000325), received between Mar 29, 2024 and Dec 1, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem3
- Insufficient Device Problem Information1
Patient problems
- Perforation of Vessels3
- Vascular Dissection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
VESSEL DISSECTION NOTED BY PHYSICIAN LEADING TO FURTHER INTERVENTIONAL PROCEDURES TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION GIVEN.
Patient problems: Vascular Dissection
MAUDE report 23689052 ↗InjuryJul 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
PERFORATION OCCURRED, PROCEDURE WAS COMPLETED USING A STENT.
Patient problems: Perforation of Vessels
MAUDE report 22473502 ↗InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PERFORATION OCCURRED, PROCEDURE WAS COMPLETED USING A STENT.
Patient problems: Perforation of Vessels
MAUDE report 22469975 ↗InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EXTRAVASATION/PERFORATION OF A VEIN DURING A PROCEDURE TREATING A LESION AT THE TRANSITION TO THE SUBCLAVIAN VEIN. DURING OPERATION, A VEIN AT THE TRANSITION TO THE SUBCLAVIAN VEIN, A PERFORATION OF THE VESSEL OCCURRED. TREATMENT WITH A COVERED STENT 8MM, AFTER DILATION (APPROX. 1 MINUTE).
Patient problems: Perforation of Vessels
MAUDE report 19008385 ↗
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- AngioSculpt OTW PTA Scoring Balloon Catheter 2105-6040The Spectranetics Corporation · Catheter, Percutaneous, Cutting/Scoring17 reports
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- ULTRASCORE US14150530Bard Peripheral Vascular, Inc. · Catheter, percutaneous, cutting/scoring15 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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