FDA Enforcement
Class II
Ongoing
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
Recall: Z-1084-2024
·
Reported February 21, 2024
Enforcement
- Recall Number
- Z-1084-2024
- Event ID
- 93678
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 21, 2024
- Initiation Date
- December 6, 2023
- Classification Date
- February 14, 2024
- Address
- 4870 West 2100 South, N/A, Salt Lake City, UT, 84104, United States
Description
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
Reason
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
Code Info
UDI: (01)00815742002386/Lot Number(s): 0000228865 0000370674
Distribution
US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.
Quantity
11 units