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Early Alert: Surgical Stapler Issue from Intuitive Surgical
The FDA is aware Intuitive Surgical has issued a letter to affected customers recommending certain curved-tip staplers be removed from where they are used or sold. 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, 2026, Intuitive Surgical has reported four serious injuries and one death associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Intuitive Surgical at customerservice@intusurg.com or call 800-876-1310.
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