Medium RiskFDA Device

Intuitive Surgical, Inc.: Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

Agency Publication Date: May 31, 2022

Affected Products

Product: VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422

UDI: 00886874115664. All lots

Product: DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440

UDI: 00886874117309. All lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89641

Status: Active

Manufacturer: Intuitive Surgical, Inc.

Manufactured In: United States

Units Affected: 2 products (140,519 boxes (843,113 individual units); 7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.