Z-0702-2022Class II

da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11

Name: Z-0702-2022 da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Creator: Intuitive Surgical, Inc.
Published: 2021-12-23
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2021-12-23 / Open, Classified / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 on 2021-12-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0702-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-23
Posted: 2022-03-01
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 12/23/21 recall notices were mailed to customers who were asked to do the following: 1. Inform necessary hospital personnel about this issue. 2. Locate all affected devices at your site and return to the recalling firm. 3. Inform affected personnel when the requested actions have been completed. 4. Complete and return the attached Acknowledgement Form 5. Please retain a copy of this letter and the acknowledgement form for your files. If you need further information or support contact your Clinical Sales Representative or contact Intuitive Customer Service: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected] Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or [email protected] Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or [email protected] Taiwan: 886-2-27008181 (7:30am to 5:30pm CT) or [email protected] Distributors were asked to provide their customers with the information found in the recall notice; the notice the recalling firm sent to their customers was included as an attachment. Distributors are to collect the affected cannula reducers and return them to the recalling firm. Distributors were asked to complete and return a recall response form. They were also asked to follow-up with their customers who don't respond to the recall notice at least three times.
Quantity in commerce: 149,646 reducers
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, Michigan, Oregon, Kentucky, Hawaii, Tennessee, Alabama, Nebraska, Maryland, Oklahoma, Colorado, Arkansas, Arizona, Kansas, Illinois, South Carolina, Minnesota, North Dakota, Iowa, Louisiana, Washington, Delaware, Mississippi, New Mexico, District of Columbia, Idaho, New Hampshire, Rhode Island, West Virginia, South Dakota, Alaska, Maine, Utah, Montana, Vermont, Wyoming, Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Luxembourg, Martinique, Monaco, Netherlands, Norway, Poland, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
Product codes and lots: UDI: 00886874112588 L10210114 L10210115 L10210122 L10210125 L10210128 L10210204 L10210205 L10210211 L10210212 L10210215 L10210216 L10210217 L10210218 L10210219 L10210225 L10210226 L10210301 L10210304 L10210305 L10210308 L10210309 L10210316 L10210317 L10210318 L10210321 L10210322 L10210513 L10210514 L10210520 L10210521 L10210527 L10210528 L10210529 L10210715 L10210716 L10210717 L10210718 L10210719 L10210720 L10210722 L10210723 L10210731 L10210801 L10210803 L10210805 L10210806 L10210807 L10210808 L10210809 L10210812 L10210813 L10210819 L10210924 L10210925 L10210926 L10210930 L11210111 L11210316 M10210330 M10210331 M10210405 M10210408 M10210409 M10210412 M10210415 M10210416 M10210422 M10210423 M10210429 M10210430

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0702-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0702-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-09	2022-03-01

Product code NAY

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)