Z-2720-2024Class II

Ion Endoluminal System, REF: 380748-65

Name: Z-2720-2024 Ion Endoluminal System, REF: 380748-65
Creator: Intuitive Surgical, Inc.
Published: 2024-07-12
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2024-07-12 / Open, Classified

FDA source

Intuitive Surgical, Inc. began a recall of Ion Endoluminal System, REF: 380748-65 on 2024-07-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2720-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-12
Posted: 2024-08-23
Recalling firm: Intuitive Surgical, Inc.
Product: Ion Endoluminal System, REF: 380748-65
Product code: EOQ Bronchoscope (Flexible Or Rigid)
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the states of AZ and CA.
Product codes and lots: UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2720-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2720-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23

Product code EOQ

K182188Class IIIon Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical / cleared 2019-02-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)