Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Box Label: ION Fully Articulating Catheter Recalled by Intuitive Surgical, Inc. Due to The distal tip ring of the fully articulating...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Intuitive Surgical, Inc. directly.
Affected Products
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12
Quantity: 454 catheters
Why Was This Recalled?
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. has 244 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report