Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

FDA device recall Z-1085-2024 · posted 2024-02-14 · Open, Classified

Recall details

Recalling firm

Stryker, Inc.

Reason for recall

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

Action taken

On December 22, 2023, Stryker Neurovascular issued a "Urgent: Medical Device Recall" notification to affected consignees. Stryker asked consignees to take the following actions: Immediately check your internal inventory for affected devices. 2. The affected items may continue to be used. 3. When using impacted lot(s) of Trevo Trak 21 or Trevo Pro 18 microcatheter, please follow the IFU attached in this communication instead of the one that originally came with the device. 4. Circulate this Customer Notification internally to all interested/affected parties. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately. 7. Please inform Stryker 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) 8. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. 9. Email the completed form to nvfieldactions@stryker.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QJP

Quantity affected

63 units

Distribution

US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.

Date initiated

2023-12-06

Date posted

2024-02-14

Location

Salt Lake City, UT

Related 510(k) clearances