Ion Endoluminal System (Intuitive Surgical) – Arm Screw Risk (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On July 12, 2024, Intuitive issued a "Urgent Medical Device Correction" notification to affected consignees via E-Mail. 1. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 2. Please retain a copy of this letter, place a copy with your affected system, and keep the acknowledgement form for your files. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. An Intuitive Representative will schedule a site visit to perform replacement of the affected FIM assembly. Once replaced by the Intuitive Representative the Ion System can be used as designed. 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, regular mail, or fax.