Intuitive Surgical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2350-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.

Product Classification:

Class II

Date Initiated: July 14, 2016

Date Posted: August 17, 2016

Recall Number: Z-2350-2016

Event ID: 74705

Reason for Recall:

An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend

Status: Terminated

Product Quantity: 2065 total

Code Information:

All

Distribution Pattern:

US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated