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The Distal Access Catheter is a single-lumen, braided… recallZ-1740-2024 · Stryker Neurovascular · initiated Apr 3, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Neurovascular or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Release of Material/Component prior to receiving test results

What the company is doing

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: [email protected]) 5) Complete and return the customer response form to [email protected]

Recall details

Recall number
Z-1740-2024
Status
Open, Classified
Initiated by the company
Apr 3, 2024
Posted by the FDA
May 1, 2024
Recalling firm
Stryker Neurovascular
Quantity
43
Product code
DQY
FDA submissions
K133177
Distribution
US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL.

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.

Code information (models, lots, serial numbers)

UDI-DI: 07613327313895, Lot: 0000486382, Expiration: 17-Jul-2025

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

4 devices cleared under K133177 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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