Intuitive Surgical, Inc.: Device Recall

Recall #Z-2720-2024 · 07/12/2024

Class II: Risk

Recall Details

Recall Number: Z-2720-2024
Classification: Class II
Product Type: Device
Recalling Firm: Intuitive Surgical, Inc.
Status: Ongoing
Date Initiated: 07/12/2024
Location: Sunnyvale, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3 units

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.

Product Description

Ion Endoluminal System, REF: 380748-65

Distribution Pattern

US Nationwide distribution in the states of AZ and CA.

Other Recalls by Intuitive Surgical, Inc.

Class II: Risk 12/15/2025

Access Port System tray may develop cracks potentially resulting in a sterility breach.
Class II: Risk 12/04/2025

Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Class II: Risk 11/07/2025

Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
Class II: Risk 02/26/2025

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
Class II: Risk 12/19/2024

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

View all recalls by Intuitive Surgical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.