Scientia Vascular, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1235-2025)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2025.
Data Source: FDA.
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.
Product Classification:
Class II
Date Initiated: January 16, 2025
Date Posted: March 5, 2025
Recall Number: Z-1235-2025
Event ID: 96175
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.
Status: Ongoing
Product Quantity: 1 unit
Code Information:
Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300
Distribution Pattern:
U.S. Nationwide distribution in the state of DE.
Voluntary or Mandated:
Voluntary: Firm initiated