Intuitive Surgical is recalling 75,247 instruments, including 33,219 Tenaculum Forceps and 42,028 Small Graptors, which are used with da Vinci X/Xi Surgical Systems. The recall is due to an increase in reported failures of the instruments' pitch cables, which are critical for controlling device movement during procedures. These instruments are used across a wide variety of surgeries for tasks such as manipulating and retracting tissue. Hospitals and surgical facilities should stop using the affected instruments and contact the manufacturer to arrange for their return or correction.
The pitch cables within these surgical instruments can fail during use, which may lead to a loss of control over the instrument's tip during surgery. This malfunction could potentially cause tissue damage or leave debris in the surgical field, and there has been a reported increase in complaints related to this specific failure.
Instrument used with the da Vinci X/Xi Surgical Systems for manipulation and retraction of tissue.
Grasping retractor instrument used with the da Vinci X/Xi Surgical Systems for manipulation and retraction of tissue.
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.