CLASS II ONGOING Device recall · Reported 9 Mar 2022 · FDA Enforcement Report
da Vinci Xi and X 12- Conductive Cannula Reducer recalled
Intuitive Surgical is recalling da Vinci Xi and X 12- Conductive Cannula Reducer, distributed nationwide in the US. The recall was initiated on 23 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0702-2022
- FDA event ID
- 89274
- Recalling firm
- Intuitive Surgical, Sunnyvale, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Dec 2021
- FDA classified
- 1 Mar 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 23 Dec 2021 | Recall initiated by company | |
| 1 Mar 2022 | Classified by FDA | +68 days |
| 9 Mar 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is da Vinci Xi and X 12- Conductive Cannula Reducer recalled?
Yes. Intuitive Surgical recalled da Vinci Xi and X 12- Conductive Cannula Reducer on 23 Dec 2021. The recall is Class II and its status is Ongoing. Recall number Z-0702-2022.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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