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
Product summary
- 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
breach in the sterile barrier