Scientia Vascular, Inc. recalls Plato 17 Microcatheter REF PL17-160-090 To assist in deli
Recalled 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.
Hazard / Issue
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.
Issued by
FDA
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