Recall Z-2380-2018— Intuitive Surgical, Inc.

Name: FDA recall Z-2380-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-23

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2018-04-23, terminated 2020-07-15. It names one FDA 510(k) clearance: K140553. Product: da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.. Reason: Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-04-23
Terminated: 2020-07-15
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K140553 — ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSIntuitive Surgical, Inc.·cleared 2014-07-25

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 Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.

Reason for recall

Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.

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