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Intuitive Surgical, Inc. recalls Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulat
Recalled December 2, 2020 · FDA recall Z-0489-2021 · Intuitive Surgical
Hazard
The distal tip ring of the fully articulating catheter may become dislodged during the procedure. · FDA Class II
Units
454 catheters
Sold at
US Nationwide distribution including in the states of CA, CO, DC, FL, IA, IL, MA, MD, MI, MN, NC, NJ, NY, OH, PA, TX, UT, and VA.
Description
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Product
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
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →