Intuitive Surgical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1376-2016)

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:

da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.

Product Classification:

Class II

Date Initiated: March 16, 2016

Date Posted: April 20, 2016

Recall Number: Z-1376-2016

Event ID: 73649

Reason for Recall:

Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.

Status: Terminated

Product Quantity: 248 - all models

Code Information:

Model 550675; IS1200/IS2000/IS3000 - User Manual, Instrument & Accessory - all languages.

Distribution Pattern:

Worldwide Distribution - US Nationwide in the countries Australia, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Greece, Iceland, India, Israel, Italy, Netherlands, Qatar, Russia, Singapore, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated