VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling Vessel Sealer Extend single-use instruments for the da Vinci X and da Vinci Xi surgical systems worldwide. The devices can produce an insufficient seal if excessive tissue is placed in the instrument jaws before sealing and transection occurs. The recall affects 140,519 boxes containing 843,113 individual units across all lots, distributed to the United States and numerous countries worldwide.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Reason for recall: Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal. 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, Pan Quantity: 140,519 boxes (843,113 individual units) Lot/code info: UDI: 00886874115664. All lots
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.