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Open, Classified

Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm

FDA Recall Z-1084-2024 · Posted 2024-02-14

Recalling FirmStryker, Inc.
Recall StatusOpen, Classified
Product CodeDQO
Date Initiated2023-12-06
Product Quantity11 units

Reason for Recall

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

Firm Action

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: [email protected]) 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 [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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