Route 92 Medical is recalling 1,096 units of several neurovascular access and reperfusion systems, including the Tenzing 7 Delivery Catheter and 070 Access/Reperfusion Systems. The recall was initiated because the distal tip of the delivery catheter may separate at the proximal marker band during use. These sterile devices are used by medical professionals to introduce interventional tools into the blood vessels of the brain or to remove blood clots in stroke patients. If you or a loved one have undergone a neurovascular procedure involving these devices, contact your healthcare provider for more information.
The catheter tip may break off or separate inside the patient's blood vessels during a procedure. This can lead to serious complications such as blocked blood flow, stroke, or the need for additional invasive surgery to retrieve the separated piece.
Healthcare provider or manufacturer consultation
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.