EndoWrist;daVinci Si recallZ-1459-2022 · Intuitive Surgical, Inc. · initiated Jul 1, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 07/01/2022, Intuitive Surgical sent an "Urgent Medical Device Correction" Letter to customers via FedEx courier informing them there is the potential for unexpected motion while using the da Vinci S/Si and X/Xi Endowrist Clip Applier Instruments. This can happen when one of the da Vinci S/Si and X/Xi Clip Applier grip discs are disengaged from the sterile adapter disc during the engagement routine that occurs prior to insertion of the instrument into the cannula and into the patient. To mitigate this issue, Intuitive Surgical has developed a Clip Applier Manual Self-Test (Appendix A) that is part of the Urgent Medical Device Correction Letter. This test is performed by moving the Clip Applier grips through the full range of yaw motion (side-to-side in the plane of the instrument grips) and observing the movement of both the instrument grips prior to placing a clip around a vessel/tissue. This test should be performed in an open space to prevent any collisions. Pass Criteria " During the yaw movement, if the grips remain open with no observation of grips closing then the instrument passes the self-test and users may proceed with using the clip applier instrument in a procedure. Fail Criteria " During yaw movement, if the grips begin to close as opposed to the grips remaining open then there is potential that one of the grip discs is not engaged. Instrument should be removed, reinstalled, and inspected for engagement. If the self- test fails, remove Clip Applier instrument, re-install and repeat self-test. If it fails again, use a different Clip Applier instrument and return the instrument using the standard Intuitive RMA process. Please call customer service to return the affected product using the appropriate local number listed in section 6 of the letter. Credit will be issued when the reported unexpected motion is confirmed. For questions: " US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg
Recall details
- Recall number
- Z-1459-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 1, 2022
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 62,895 Clip appliers
- Product code
- NAY
- FDA submissions
- K050369
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Product description
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
Code information (models, lots, serial numbers)
Model/Model Number/UDI Number Da Vinci S/Si Large Clip Applier / 420230 / 00886874111680 Da Vinci S/Si Medium-Large Clip Applier / 420327 / 00886874111826 Da Vinci S/Si Small Clip Applier / 420003 / 00886874111161 Serial Numbers: All
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- EndoWrist;daVinci Si 420230Intuitive Surgical, Inc. · System,surgical,computer controlled instrument1 recall18 reports
- EndoWrist;daVinci Si 420327Intuitive Surgical, Inc. · System,surgical,computer controlled instrument1 recall10 reports
- EndoWrist;daVinci Si 420003Intuitive Surgical, Inc. · System,surgical,computer controlled instrument1 recall5 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90332).
- Z-1460-2022 · Open, ClassifiedDa Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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