Recall Z-2720-2024— Intuitive Surgical, Inc.

Name: FDA recall Z-2720-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-12

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2024-07-12. It names one FDA 510(k) clearance: K182188. 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..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-07-12
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K182188 — Ion Endoluminal System; Flexision Biopsy NeedleIntuitive Surgical·cleared 2019-02-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ion Endoluminal System, REF: 380748-65

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.