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