Intuitive Surgical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2677-2016)

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; General and Plastic Surgery: 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: September 7, 2016

Recall Number: Z-2677-2016

Event ID: 74811

Reason for Recall:

Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.

Status: Terminated

Product Quantity: 875 instruments (827 a la carte + 48 in kits); total, all models

Code Information:

All model 470530

Distribution Pattern:

Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,

Voluntary or Mandated:

Voluntary: Firm initiated