FDA Device recall Z-0489-2021
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within…
- FDA Device
- Class II
- terminated
- Published 2020-12-02
On 2020-12-02 the FDA classified a Class II recall of Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within… by Intuitive Surgical, citing the distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0489-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-23 |
| Published | 2020-12-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
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
Reason
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Identifiers
| code_info | Model Number: 490105-08 UDI: 00886874116258 Lot/Serial Number: All S10181217 S10190103 S10190424 S10190424 S101…Model Number: 490105-08 UDI: 00886874116258 Lot/Serial Number: All S10181217 S10190103 S10190424 S10190424 S10190424 S10190531 S10190531 S10190605 S10190605 S10190605 S10190605 S10190605 S10190605 S10190605 S10190610 S10190610 S10190625 S10190625 S10190710 S10190802 S10190802 S10190823 S10190823 S10190823 S10190823 S10190823 S10190829 S10190829 S10190829 S10190829 S10190829 S10190829 S10190911 S10190911 S10190911 S10190911 S10190911 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191023 S10191023 S10191023 S10191023 S10191023 S10191023 S10191023 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191203 S10191203 S10191203 S10191203 S10191203 S10191203 S10191210 S10191210 S10191210 S10191210 S10191210 S10191216 S10191216 S10191216 S10191217 S10191217 S10191217 S10191231 S10191231 S1019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.