FDAFDA · Food and drugs·Recall number Z-0999-2022
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
Published May 4, 2022 · Recall initiated: March 17, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- 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, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
- Lot
- Product Description/Model Numbers/UDI Code: Sureform 45 / 480445 / 00886874117583 Sureform 45 Curved-Tip / 480545 / 00886874117590 Sureform 60 / 480460 / 00886874115640 All Lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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