FDA recall Z-1085-2024

Stryker, Inc. · Class II · device

Product

Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-12-06
Report date
2024-02-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1085-2024