FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1235-2025
·
Reported March 5, 2025
Enforcement
- Recall Number
- Z-1235-2025
- Event ID
- 96175
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Scientia Vascular, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 5, 2025
- Initiation Date
- January 16, 2025
- Classification Date
- February 26, 2025
- Address
- 2460 S 3270 W, N/A, West Valley City, UT, 84119-1116, United States
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.
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 Info
Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300
Distribution
U.S. Nationwide distribution in the state of DE.
Quantity
1 unit