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
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling approximately 90,628 clip applier instruments used with Da Vinci X and Xi surgical systems across three models: the Large Clip Applier (Model 470230), Medium-Large Clip Applier (Model 470327), and Small Clip Applier (Model 470401). The recall affects units distributed worldwide, including throughout the United States and multiple other countries. The hazard is that these instruments may experience unexpected motion caused by partial disengagement from the surgical system.
The recall involves all serial numbers of the three affected models. The source document does not specify a remedy for affected consumers or facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Reason for recall: Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system. 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, Ch Quantity: 90,628 Clip appliers Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.