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

Recalled March 5, 2025 · FDA recall Z-1235-2025 · Scientia Vascular

Hazard

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. · FDA Class II

Units

1 unit

Sold at

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

Description

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

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.

Manufacturer(s)

Scientia Vascular, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →