da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number:… recallZ-2722-2026 · Intuitive Surgical, Inc. · initiated May 12, 2025

Why it was recalled

Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.

FDA root cause category: Process control

What the company is doing

On 5/12/2025, correction notices were emailed to customers informing them of the following: 1) Conduct pre-use inspection steps outlined prior to each procedure, see below. 2) If you encounter a drape that does not pass the inspection steps, contact firm customer service. 3) Complete and return the acknowledgement form via email to [email protected] or [email protected] If you need further information or support concerning this Safety Notice, please contact your Clinical Sales Representative or contact firm Customer Service at the numbers listed below: - North and South America: (800) 876-1310, Option 3 or mail: [email protected]. - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 or [email protected] - South Korea: 02-3271-3200or [email protected] - Japan: 0120-56-5635 or 03-5575-1362 or [email protected] " Taiwan: +0800-86-8181 Pre-Use Inspection Steps: 1. Fully drape the da Vinci SP system according to user manual. 2. Press and hold the Instrument Arm Clutch button. Top Instrument arm clutch, not recommended. 3. While holding the Instrument Arm Clutch button, manually rotate the instrument drive cluster in one direction, 360-degrees. Then, rotate the instrument drive at least 360-degrees in the other direction. Stop immediately and press "deploy for draping" again to rehome the instrument drive cluster to replace the drape if you observe any of the following behaviors: a. Inability to rotate the instrument drive 360-degrees in both directions b. VSC message that drape is not fully attached (VSC message: "Check drape is secure to all 4 instrument arm clips" or "Insecure or missing drape. The drape may not be properly secured and could fall. Ensure the drape is properly connected to all 4 mounts to continue"). c. Drape outer ring falls off silver section of system. d. Any of the 4 dark gray marks disengage from the dark gray connectors during the rotation.

Recall details

Recall number

Z-2722-2026

Status

Open, Classified

Initiated by the company

May 12, 2025

Posted by the FDA

Jul 10, 2026

Recalling firm

Intuitive Surgical, Inc.

Quantity

11113

Product code

NAY

FDA submissions

K182371, K173906

Distribution

Worldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL, SD, TX, VA, WV, PA, CA, WA, CT, MA, IL, OK, OH, MI, NC, MO, KY, WI, AZ, CO, GA, MD, SC, IN, NV, TN, MS, KS, IA, UT, MN, LA, NE, ME and the countries of Germany, Sweden, United Kingdom, Italy, Belgium, Switzerland, Denmark, Japan, South Korea, Hong Kong, Taiwan, France, Ireland, Spain.

Product description

da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• None 430013

  Intuitive Surgical, Inc. · System, surgical, computer controlled instrument
  2 recalls139 reports