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Intuitive Surgical, Inc. Recall: Box Label: ION Fully Articulating Catheter, REF 490105, V

Intuitive Surgical, Inc. Recall: Box Label: ION Fully Articulating Catheter, REF 490105, V is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Intuitive Surgical, Inc.; Product: Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully A

Recalling firmIntuitive Surgical, Inc.
ProductBox 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
Reason for recallThe distal tip ring of the fully articulating catheter may become dislodged during the procedure.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionUS 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.
Recall initiated20201023
Recall numberZ-0489-2021
Categorydevice
StateCA
CountryUnited States

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