Use cautionMedical device recall · FDA · Published July 12, 2024
Intuitive Surgical Ion Endoluminal System Recall: Risk of Uncontrolled Catheter Motion
Intuitive Surgical recalls Ion Endoluminal System (REF: 380748-65) due to potential screw failure causing uncontrolled catheter movement in airways. Affected units have specific serial numbers.
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.
Take action
Contact the company
📍Recalling firmIntuitive Surgical, Inc.1266 Kifer Rd · Sunnyvale, CA 94086-5304
“Intuitive Surgical Ion Endoluminal System Recall: Risk of Uncontrolled Catheter Motion.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54653-intuitive-surgical-ion-endoluminal-system-recall-risk-of-uncontrolled-catheter. Based on FDA recall #Z-2720-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2720-2024%22&limit=1).
The FDA announced on July 12, 2024, that Intuitive Surgical, Inc. is recalling the Ion Endoluminal System due to a potential for uncontrolled catheter motion inside a patient's airways. The agency issued recall number Z-2720-2024 for the Class II device.
How to tell if you have it
Brand: Intuitive Surgical
Product: Ion Endoluminal System, REF: 380748-65
UDI: 00886874116234
System Serial Number/System Cart Serial Numbers: EN1230/10591271; EN1241/10591273; EN1231/10583014
Quantity: 3 units
Distribution: US Nationwide, specifically in Arizona and California
The hazard
The robotic system's instrument cart arm may contain screws that could fail. This failure could result in uncontrolled motion of a catheter inside a patient's airways.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has had 53 other recalls since June 1, 2017. Recent brand recalls include the Da Vinci 5 dV5 Tower NIR Handheld Camera (April 24, 2026) and the Intuitive Surgical Da Vinci Surgical System (April 22, 2026). Other recent recalls of similar products include the Codman CerebroFlo EVD Catheter (April 10, 2026), Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray (November 6, 2025), and Soft-Vu Angiographic Catheter (March 3, 2026).
How to tell if you have this one
Check for the product reference number 380748-65 on the system. Affected units have specific serial numbers: EN1230/10591271, EN1241/10591273, or EN1231/10583014.
Brand
Intuitive Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Serial Numbers
Verify your system's serial numbers against the listed affected units: EN1230/10591271, EN1241/10591273, or EN1231/10583014.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ and CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2720-2024 (July 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2720-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.