Z-1084-2024 Class II Ongoing

Recalled by Stryker, Inc. — Salt Lake City, UT

Recall Details

Product Type
Devices
Report Date
February 21, 2024
Initiation Date
December 6, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11 units

Product Description

Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm

Reason for Recall

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

Distribution Pattern

US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.

Code Information

UDI: (01)00815742002386/Lot Number(s): 0000228865 0000370674