Recall Z-1740-2024— Stryker Neurovascular

Name: FDA recall Z-1740-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-03

Class II · Ongoing

Class II FDA medical device recall by Stryker Neurovascular, initiated 2024-04-03. It names one FDA 510(k) clearance: K133177. Product: The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices.. Reason: Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results..

Recalling firm: Stryker Neurovascular
Classification: Class II
Status: Ongoing
Initiated: 2024-04-03
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K133177 — MODIFIED HD GUIDE CATHETERConcentric Medical, Inc.·cleared 2014-02-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices.

Reason for recall

Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.