Recall Z-0924-2025— Intuitive Surgical, Inc.

Name: FDA recall Z-0924-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-19

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2024-12-19. It names one FDA 510(k) clearance: K131861. Product: 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.. Reason: Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments.

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-12-19
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESIntuitive Surgical, Inc.·cleared 2014-03-28

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

8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.

Reason for recall

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

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