Scientia Vascular, Inc. recalls Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and inf…

Recall date

January 16, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1235-2025

FDA classification

Class II

Brand / firm

Scientia Vascular, Inc.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.