da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
FDA Device Recall #Z-0702-2022 - Class II, December 23, 2021
Recall Summary
| Recall Number | Z-0702-2022 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 23, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Intuitive Surgical, Inc. |
| Location | Sunnyvale, CA |
| Product Type | Devices |
| Quantity | 149,646 reducers |
Product Description
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
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.
Distribution Pattern
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.
Lot / Code Information
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
Other Recalls from Intuitive Surgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2310-2026 | Class II | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 ... | Apr 24, 2026 |
| Z-2521-2026 | Class II | Da Vinci ASSY, PSS, SP1098, Part Number: 380601 | Apr 22, 2026 |
| Z-2046-2026 | Class II | Brand Name: Da Vinci X and Da Vinci Xi Product... | Apr 2, 2026 |
| Z-1855-2026 | Class I | Intuitive 8 mm SureForm 30 Gray Reloads Refer... | Mar 11, 2026 |
| Z-1355-2026 | Class II | da Vinci 5 Surgeon Console Viewer Display, ASSY... | Dec 30, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.