Use cautionMedical device recall · FDA · Published December 23, 2021
Intuitive Surgical da Vinci Xi/X 12-8 mm Cannula Reducer: Metal Tip Dislodgement Risk
Intuitive Surgical recalls da Vinci Xi and X 12-8 mm Conductive Cannula Reducer (REF: 470381-11) due to risk of metal tip dislodging, potentially causing tissue damage or bowel obstruction if not removed during surgery.
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.
Intuitive Surgical is recalling da Vinci Xi and X 12-8 mm Conductive Cannula Reducers because the metal tip might detach from the plastic shaft. If not noticed, extra surgery may be needed to remove the metal tip, which could lead to tissue damage, bowel obstruction, or chronic abdominal pain. Read more at govinfonow.com/recall/61343-intuitive-surgical-da-vinci-xi-x-12-8-mm-cannula.
“Intuitive Surgical da Vinci Xi/X 12-8 mm Cannula Reducer: Metal Tip Dislodgement Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61343-intuitive-surgical-da-vinci-xi-x-12-8-mm-cannula. Based on FDA recall #Z-0702-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0702-2022%22&limit=1).
Intuitive Surgical, Inc. recalled da Vinci Xi and X 12-8 mm Conductive Cannula Reducers worldwide on Dec. 23, 2021, according to the FDA. The device's metal tip may dislodge, potentially requiring additional surgery or causing tissue damage.
How to tell if you have it
Brand: Intuitive Surgical
Product: da Vinci Xi and X 12-8 mm Conductive Cannula Reducer
REF: 470381-11
Units affected: 149,646
The hazard
The conductive cannula reducer's metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has had 53 other recalls on record since June 1, 2017. Other recent recalls of similar products include Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe Recall (Nov. 19, 2025), Merit Medical Custom Procedure Kit Recall (Dec. 4, 2025) and Olympus Resection Sheath A2666T: Ceramic Tip Breakage Risk (Nov. 11, 2025).
How to tell if you have this one
Check for the da Vinci Xi or X 12-8 mm Conductive Cannula Reducer with reference number 470381-11. The product has unique identifiers (UDI) listed in the recall notice.
Brand
Intuitive Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Dislodged Metal Tip
Inspect the cannula reducer for any metal tip that has become detached from the plastic shaft.
Contact Manufacturer for Guidance
Reach out to Intuitive Surgical directly for instructions on whether the cannula reducer needs to be removed or replaced.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of California, Wisconsin, Virginia, Ohio, Texas, New York, Nevada, Connecticut, New Jersey, Massachusetts, Georgia, Florida, Indiana, North Carolina, Missouri, Pennsylvania,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0702-2022 (December 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0702-2022 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.