Recall Z-1459-2022— Intuitive Surgical, Inc.

Name: FDA recall Z-1459-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-01

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2022-07-01. It names one FDA 510(k) clearance: K050369. Product: Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003. Reason: Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-07-01
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K050369 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000Intuitive Surgical, Inc.·cleared 2005-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003

Reason for recall

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.