Stryker Neurovascular: Medical Device Recall in 2024 - (Recall #: Z-0021-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 30, 2024

Date Posted: October 16, 2024

Recall Number: Z-0021-2025

Event ID: 95314

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.

Status: Ongoing

Product Quantity: 6

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.

Voluntary or Mandated:

Voluntary: Firm initiated