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Recall Observatory FDA recall evidence

Device product

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.

Z-0021-2025

August 30, 2024

Class II

Product summary

Firm
Stryker Neurovascular
Event
Event 95314
Status
Ongoing
Classification
Class II
Quantity
6
Official record key
device-enforcement:Z-0021-2025

Official wording

Reason: 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.

Code information: Model/Catalog Number: 90338 UDI Codes: (01)07613327313956(17)251125(10)0000590444 (01)07613327313956(17)260101(10)0000603275 Lot Numbers: 0000590444 0000603275

Distribution pattern: U.S. Nationwide distribution in the states of CA and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.