Z-0999-2022Class II

da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da...

Name: 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...
Creator: Intuitive Surgical, Inc.
Published: 2022-03-17
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2022-03-17 / Open, Classified

FDA source

Intuitive Surgical, Inc. began a recall of 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 on 2022-03-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0999-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-17
Posted: 2022-04-22
Recalling firm: Intuitive Surgical, Inc.
Product: 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
Product code: NAY System, Surgical, Computer Controlled Instrument
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 Intuitives existing risk documentation.
FDA root cause: Under Investigation by firm
Action: On 03/17/2022, the firm sent an "Urgent Medical Device Correction" letter via FedEx informing customers that there is a potential for injury associated with the stapler instruments if target tissue fails to remain in place with the jaws of the stapler during the stapler firing sequence. This phenomenon is referred to as a "tissue pushout event". As the staple firing sequence progresses, the target tissue is transected but the target tissue is not approximated due the lack of staple engagement with the tissue. This type of event may result in un-approximated tissue and occurs when attempting to cross over existing staple lines in the creation of a continuous staple line. Customer are being instructed to place the customer communication with the User Manual and in addition: 1. Read and understand the contents of the letter. 2. Notify all surgeons and personnel using the Surgical System that they should review and understand contents of this letter and reacquaint themselves by a. Reading the instructions, warnings, and cautions provided in the SureForm Instruments and Accessories User Manual Addendum b. Contacting their Sales Representatives for clarification of queries. 3. Complete the Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. Retain a copy of this letter and the acknowledgement form for their files. Customers are also informed that they can continue to use their instruments by following instructions: -Users are advised to use caution when unable to avoid crossing over existing staple lines and continue to adhere to all existing warnings and cautions found in the SureForm Instruments and Accessories User Manual Addendum. -If a tissue pushout event is occurring, users may limit unapproximated tissue by pressing the emergency stop button (on Surgeon Console or Patient Cart helm), after which the SureForm stapler can be safely unclamped from the tissue using the Manual Release Knob. For questions or fu
Quantity in commerce: 6,8881 boxes (or 413,286 individual units/6 instruments/box)
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, 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.
Product codes and lots: Product Description/Model Numbers/UDI Code: Sureform 45 / 480445 / 00886874117583 Sureform 45 Curved-Tip / 480545 / 00886874117590 Sureform 60 / 480460 / 00886874115640 All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0999-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0999-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-22

Product code NAY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)