Safety
Intuitive started a Class 2 recall of an Ion catheter because a ring at its tip could come off during a procedure.
A crash, recall, injury or investigation
What the source says
“The distal tip ring of the fully articulating catheter may become dislodged during the procedure.”
What it means
Ion, from Intuitive, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. Safety events don't move a stage on their own, but they stay on the robot's record.
Human help: The maker hasn't said whether people help it remotely.
More on Ion
- Intuitive placed 55 Ion systems in the second quarter of 2026, up from 54 a year earlier.
- The FDA cleared new Ion software, including AI and imaging features, which Intuitive planned to release through a limited launch.
- Intuitive said more than 900 Ion systems were in hospitals across 10 countries.
- China's medical device regulator approved Ion for sale in China.
- Intuitive said it would roll Ion out slowly in the US, with the first shipments to customers in the second quarter of 2019.
- The FDA cleared Ion for taking biopsies from the outer parts of the lung.