EndoWrist recallZ-1209-2022 · Intuitive Surgical, Inc. · initiated Mar 3, 2022
Completed
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
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
FDA root cause category: Use error
What the company is doing
On 03/03/22, a Field Safety Notice was sent via courier service to customers. In section 4, "Actions to be taken by the Customer/User" of the Field Safety Notice includes the following: Place the customer communication with the User Manual. In addition, 1. Read and understand the contents of the letter. 2. Notify all surgeons and personnel using the System that they should reacquaint themselves by a. Reading the instructions, warnings, and cautions provided in the Instruments and Accessories User Manual Addendum /User Manual b. Contacting Sales Representatives for clarification of queries. 3. Complete the Acknowledgement Form immediately and return it via fax or email as instructed on the form. 4. Retain a copy of the letter and the acknowledgement form for your files. 5. Inform of any adverse events/serious incidents or quality problems concerning the use of the subject devices via the standard complaint process. 6. Additionally, if adverse events/serious incidents or quality problems are experienced, follow the standard reporting process to the health authority, if applicable. The use of the instruments may be continued by following instructions provided in Section 1 of the notice and warnings and cautions listed in the user manuals. There will be follow up with updated user documentation once available. If further information is needed or support concerning the Medical Device Correction, contact the Clinical Sales Representative or contact Customer Service at the numbers listed below: " US, Puerto Rico and Dominican Republic (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected] " Europe, Middle East, Asia, South America 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 CS.Ta
Recall details
- Recall number
- Z-1209-2022
- Status
- Completed
- Initiated by the company
- Mar 3, 2022
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 140,519 boxes (843,113 individual units)
- Product code
- NAY
- FDA submissions
- K173337
- Distribution
- Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam.
Product description
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Code information (models, lots, serial numbers)
UDI: 00886874115664. All lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Endowrist 480422Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall11 deaths1,790 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89641).
- Z-1210-2022 · CompletedDAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
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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