FDA Device Recall Z-0021-2025: Stryker Neurovascular

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0021-2025.

Recall Res Number

Z-0021-2025

Recalling Firm / Manufacturer

Stryker Neurovascular

FEI Number

3008853977

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-08-30

Date Posted

2024-10-07

Date Terminated

N/A

Product Code

QJP

Event Number

95314

Product Quantity

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.

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.

Action Details On 09/12/2024, the firm sent via FedEx an "URGENT: MEDICAL DEVICE RECALL - Customer Notification" Letter to customers informing them that certain lots of Trevo Trak 21 Microcatheters were shipped with the incorrect configuration. The affected products contained Instructions for Use (IFUs) and product labels for international use, instead of the United States (US). The International IFUs contain intended uses that have not been cleared/approved for the U.S. market. Customer are instructed to: 1. Immediately check internal inventory for affected devices. 2. When using impacted lot(s) of Trevo Trak 21 Microcatheters, follow the US IFU attached in this communication NV00055463-02 (Attachment A) instead of the one that originally came with the device. 3. Circulate recall notification internally to all interested/affected parties and post this customer notification on or near affected products. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform Stryker Neurovascular if the subject devices have been distributed to other organizations and provide contact details so that Stryker Neurovascular can inform the recipients appropriately. 6. Inform Stryker Neurovascular 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). 7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form allow for updating records and will also negate the need to send any further unnecessary communications on this matter. 8. Email the completed form to nvfieldactions@stryker.com. Contact the local Stryker representative, send an email to nvfieldactions@stryker.com or call US Customer Service: 1-855-91-NEURO (1-855-916-3876) for further assistance related to this Medical Device Recall Customer Notification.

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

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

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Medical Device Recall: Z-0021-2025

Recall Parameters & Description

Related Establishments / Registrations

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