—#206975

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.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K133177
Affected lot / code info: UDI-DI: 07613327313895, Lot: 0000486382, Expiration: 17-Jul-2025

Why it was recalled

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.

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

On 4/3/24, recall notices were mailed to Supply Chain Management/ Recall Coordinator/ Inventory Managers informing them: 1) Segregate the affected units in a secure location for return to the firm. Circulate this Recall-Removal notice internally to all interested/affected parties. 2) Maintain awareness of this communication internally until all required actions have been completed within your facility. 3) Inform the firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so the firm can inform the recipients appropriately. 4) Inform the firm of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: NVCustomerCare@stryker.com) 5) Complete and return the customer response form to nvfieldactions@stryker.com

Recalling firm

Firm: Stryker Neurovascular
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL.

Timeline

Recall initiated: 2024-04-03
Posted by FDA: 2024-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206975. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.