FDA recall Z-1235-2025

Scientia Vascular, Inc. · Class II · device

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.

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

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

Key facts

Status
Ongoing
Initiation date
2025-01-16
Report date
2025-03-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Valley City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1235-2025