Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Summary
The FDA issued a Class II for Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm by Stryker, Inc.. Reason: The microcatheter IFU contains an intended use that has not been evaluated by the FDA..
Details
Source
Device Recall
External ID
Z-1085-2024
Action Date
2024-02-21
Status
Ongoing
Category
device
Product Description
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Lot/Code Info: UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674
Quantity Affected: 63 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-06
Company
Salt Lake City, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker, Inc. have FDA actions?
Stryker, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1085-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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