Stryker Neurovascular has recalled 6 units of the Trevo Trak 21 Microcatheter because they were distributed with packaging and instructions intended for use outside of the United States. This error means the devices have different configurations and labeling than what is approved for U.S. hospitals. The affected microcatheters were distributed in California and Virginia.
Using a medical device with incorrect instructions or labeling can lead to improper use by surgical teams, potentially causing procedural delays or complications during delicate neurovascular procedures. No injuries have been reported to date regarding this specific distribution error.
Manufacturer Notification
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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