Stryker, Inc. is recalling 74 units of Trevo Pro 18 and Trevo Trak 21 Microcatheters because the Instructions for Use (IFU) include a specific intended use that has not been evaluated or cleared by the FDA. This voluntary recall affects two distinct models distributed across 12 U.S. states. Using a medical device for an unvetted purpose can lead to unpredictable performance or safety outcomes during neurovascular procedures. Consumers and healthcare providers should contact the manufacturer or their healthcare representative for guidance on how to manage the affected inventory.
The device instructions include an intended use that was not reviewed by the FDA, which means the safety and effectiveness of the device for that specific application have not been established. This could potentially lead to procedural complications if used in ways the FDA has not validated.
Manufacturer guidance and potential refund/replacement
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.