FDA Device recall Z-2720-2024
Ion Endoluminal System, REF: 380748-65
- FDA Device
- Class II
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class II recall of Ion Endoluminal System, REF: 380748-65 by Intuitive Surgical, citing there is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a pa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2720-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-12 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
Ion Endoluminal System, REF: 380748-65
Reason
There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
Identifiers
| code_info | UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2720-2024%22
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