Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of Recalled by Scientia Vascular, Inc. Due to Due to manufacturing non-conformance that resulted in channels...

Date: January 16, 2025
Company: Scientia Vascular, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Scientia Vascular, Inc. directly.

Affected Products

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.

Quantity: 1 unit

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Scientia Vascular, Inc.

Scientia Vascular, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report