Intuitive Surgical ION Catheter Recall: Distal Tip Ring May Dislodge During Procedure
Intuitive Surgical recalls ION Fully Articulating Catheter model 490105-08 (VER 08) due to risk of distal tip ring dislodging during procedures. All units with serial numbers listed may be affected.
Use caution until it’s fixed
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Contact the company
What happened, in plain English
Intuitive Surgical is recalling ION Fully Articulating Catheter model 490105-08 (version 08) because the distal tip ring might become dislodged during medical procedures. This could lead to complications if the catheter moves unexpectedly in the lung. Read more at govinfonow.com/recall/64057-intuitive-surgical-ion-catheter-recall-distal-tip-ring-may-dislodge.
Source Summary by GovInfoNow · govinfonow.com/recall/64057-intuitive-surgical-ion-catheter-recall-distal-tip-ring-may-dislodge · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0489-2021
Cite this page
“Intuitive Surgical ION Catheter Recall: Distal Tip Ring May Dislodge During Procedure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64057-intuitive-surgical-ion-catheter-recall-distal-tip-ring-may-dislodge. Based on FDA recall #Z-0489-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2021%22&limit=1).
Why it’s dangerous
The distal tip ring of the catheter can become dislodged during medical procedures, potentially causing the catheter to move unexpectedly in the lung. This could lead to complications such as unintended tissue damage or procedural errors.
Who’s affected
Healthcare professionals using the ION Fully Articulating Catheter for lung procedures are affected. Patients undergoing these procedures are at risk if the catheter dislodges during treatment.
How to tell if you have this one
Check for the model number 490105-08 (version 08) on the product label. Affected units have serial numbers listed in the recall notice, including many starting with S10181217 through S10200825.
- Brand
Intuitive Surgical- Category
Medical device
What to do — step by step
Check Product Label
Look for the model number 490105-08 (version 08) on the catheter label.
Verify Serial Number
Confirm if your catheter has a serial number listed in the provided range (S10181217 to S10200825).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 17 states.
FDA distribution: “US Nationwide distribution including in the states of CA, CO, DC, FL, IA, IL, MA, MD, MI, MN, NC, NJ, NY, OH, PA, TX, UT, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, District of Columbia, Florida, Illinois, Iowa, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Utah, Virginia.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this catheter used for lung procedures?
Yes, the ION Fully Articulating Catheter is used to navigate within the lung to a planned path for sampling targets.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0489-2021 (October 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0489-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.