FDA Concerned About Adverse Events from Intuitive Surgical

The FDA is aware that Intuitive Surgical has issued a letter to affected customers recommending certain curved-tip staplers be removed from where they are used or sold. The FDA said: "On March 11, 2026, Intuitive Surgical sent all affected customers a letter asking them to take the following actions: Identify, stop use, and quarantine all affected product. If you have shared or further distributed these products, notify appropriate staff and ensure they locate and return any affected product. At this time, Intuitive surgical recommends using alternative options." The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available. Intuitive Surgical has reported instances of incomplete staple lines after the da Vinci Surgical System returns a completed stapler fire with Gray reloads on blood vessels. Incomplete staple line formation on blood vessels will result in tissue being surgically cut and the contents of the cut vessel becoming fully exposed, causing bleeding that may require conversion to an open surgical technique. As of February 23, Intuitive Surgical has reported four serious injuries and one death associated with this issue, the FDA said.