Scientia Vascular, Inc.: Device Recall

Recall #Z-1235-2025 · 01/16/2025

Class II: Risk

Recall Details

Recall Number: Z-1235-2025
Classification: Class II
Product Type: Device
Recalling Firm: Scientia Vascular, Inc.
Status: Ongoing
Date Initiated: 01/16/2025
Location: West Valley City, UT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 unit

Reason for Recall

Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.

Product Description

Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.

Distribution Pattern

U.S. Nationwide distribution in the state of DE.

Other Recalls by Scientia Vascular, Inc.

Class II: Risk 01/02/2025

Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.

View all recalls by Scientia Vascular, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.