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Recall Observatory FDA recall evidence

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.

Z-1235-2025

January 16, 2025

Class II

Product summary

Firm
Scientia Vascular, Inc.
Event
Event 96175
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1235-2025

Official wording

Reason: 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.

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach in the sterile barrier