da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
FDA Recall Z-2380-2018 · Posted None
Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeGDW
Date Initiated2018-04-23
Date Terminated2020-07-15
Product Quantity7337
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.
Firm Action
Intuitive Surgical, Inc. (ISI) conducted the recall and notified customers via letter "Field Safety Notice Urgent Medical Device Notification" sent the week of April 23, 2018. The letter notified customers of the recall, reason for field action, risk to health, affected products, Actions to be taken by the Customer/User, Actions to be taken by Intuitive Surgical, and Further Information and Support: If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below:
"North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected].
"Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8AM to 6 PM CET) or [email protected]
"South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ)
"Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST).
Root Cause
Nonconforming Material/Component
Distribution Pattern
U.S., foreign and government accounts. Foreign: Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.