Home / Recalls / Scientia Vascular, Inc. / Z-1235-2025

Z-1235-2025 Class II Ongoing

Recalled by Scientia Vascular, Inc. — West Valley City, UT

Recall Details

Product Type: Devices
Report Date: March 5, 2025
Initiation Date: January 16, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 unit

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.

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.

Distribution Pattern

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

Code Information

Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300