Z-1460-2022Class II

Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci...

Name: Z-1460-2022 Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci...
Creator: Intuitive Surgical, Inc.
Published: 2022-07-01
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2022-07-01 / Open, Classified / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of Da 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 on 2022-07-01. FDA classified it as Class II and gives the reason as "Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system". 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-1460-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-01
Posted: 2022-07-25
Recalling firm: Intuitive Surgical, Inc.
Product: Da 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
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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
Quantity in commerce: 90,628 Clip appliers
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 codes and lots: Model/Model Number/UDI Number Da Vinci X/Xi Large Clip Applier / 470230 / 00886874112380 Da Vinci X/Xi Medium-Large Clip Applier / 470327 / 00886874112465 Da Vinci X/Xi Small Clip Applier / 470401 / 00886874112670 Serial Numbers: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1460-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1459-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-25
Z-1460-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-25

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)