da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling da Vinci SureForm staplers used in surgical procedures, including the SureForm 45, SureForm 45 Curved-Tip, and SureForm 60 models. The recall was initiated because the company identified tissue pushout events during stapler firing, where tissue is pushed out of the jaws rather than being held in place and cut, resulting in bleeding of critical severity. The rate of serious bleeding associated with these devices exceeds what was previously predicted in the company's risk documentation. Approximately 413,286 individual units across all lot numbers have been distributed worldwide, including throughout the United States and multiple international countries.
The recall notice does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive s existing risk documentation.
Reason for recall: As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive s existing risk documentation. 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, Chile, Colombia, Cyprus, Quantity: 6,8881 boxes (or 413,286 individual units/6 instruments/box) Lot/code info: Product Description/Model Numbers/UDI Code: Sureform 45 / 480445 / 00886874117583 Sureform 45 Curved-Tip / 480545 / 00886874117590 Sureform 60 / 480460 / 00886874115640 All Lots
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.