The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s)
Summary
The FDA issued a Class II for The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiff by Stryker Neurovascular. Reason: Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and ca.
Details
Source
Device Recall
External ID
Z-0021-2025
Action Date
2024-10-16
Status
Ongoing
Category
device
Product Description
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
Lot/Code Info: Model/Catalog Number: 90338 UDI Codes: (01)07613327313956(17)251125(10)0000590444 (01)07613327313956(17)260101(10)0000603275 Lot Numbers: 0000590444 0000603275
Quantity Affected: 6
Reason for Recall
Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.
Distribution
U.S. Nationwide distribution in the states of CA and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-30
Company
Fremont, CA
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 123 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Neurovascular has 26 FDA actions in our database, including 14 recalls and 12 clearances.
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 Neurovascular) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Neurovascular have FDA actions?
Stryker Neurovascular has 26 FDA actions in our database, including 14 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0021-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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