Intuitive Surgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1142-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.

Product Classification:

Class II

Date Initiated: February 11, 2015

Date Posted: March 4, 2015

Recall Number: Z-1142-2015

Event ID: 70467

Reason for Recall:

Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.

Status: Terminated

Product Quantity: 3282 - total both part numbers

Code Information:

PN 480322-04, Lot numbers: S10140730 S10140904 S10141007 S10141103 S10140805 S10140912 S10141009 S10141111 S10140814 S10140916 S10141015 S10141118 S10140824 S10140923 S10141020 S10141125 S10140827 S10141001 S10141028.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, China, Denmark, Ecuador, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated