FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: Ion Endoluminal System, REF: 380748-65
- Recall number
- Z-2720-2024
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- Ion Endoluminal System, REF: 380748-65
- Status
- Open, Classified
- Initiated
- 2024-07-12
- Posted
- 2024-08-23
- Terminated
- not on file
- 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.
- 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
- 3 units
- Distribution
- US Nationwide distribution in the states of AZ and CA.
- Lot, serial or model codes
- UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014
- 510(k) numbers
- ["K182188"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28