FDA-Device2022-06-08Class II
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Hazard
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Sold states
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.
Affected count
140,519 boxes (843,113 individual units)
Manufactured in
1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, United States
Products
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1209-2022More Intuitive Surgical, Inc. recalls
- FDA-Device2026-07-01Intuitive Surgical Da Vinci surgical system recalled for E-brake failure risk
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