Intuitive Surgical, Inc. VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
UDI: 00886874115664. All lots
Products Sold
UDI: 00886874115664. All lots
Intuitive Surgical, Inc. is recalling VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF due to Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Recommended Action
Per FDA guidance
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: customerservice@intusurg.com " Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com " South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com " Taiwan: 886-2-27008181 (7:30am to 5:30pm CT) or CS.Ta
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026