Ion recallZ-2720-2024 · Intuitive Surgical, Inc. · initiated Jul 12, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2720-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 12, 2024
- Posted by the FDA
- Aug 23, 2024
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 3 units
- Product code
- EOQ
- FDA submissions
- K182188
- Distribution
- US Nationwide distribution in the states of AZ and CA.
Product description
Ion Endoluminal System, REF: 380748-65
Code information (models, lots, serial numbers)
UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ion 380748Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)1 recall97 deaths1,278 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page