Intuitive Surgical, Inc. has recalled 317 units of the Da Vinci Single-Site Wristed Needle Driver (5 mm, Model REF 478115). This recall was initiated because the needle drive may become dislodged or break during use, which can lead to uncontrollable movement of the surgical instrument. If you are a healthcare provider using this equipment, you should check your inventory for the specific serial numbers listed in the recall. You are advised to contact the manufacturer immediately for further instructions and potential remedy options.
The needle drive mechanism can break or shift out of its intended position, causing the surgical instrument to move unpredictably. This uncontrollable movement during a procedure could lead to internal tissue damage or other surgical complications.
manufacturer or healthcare provider 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.