Health product recall

Da Vinci Xi/X Sureform 45/60 Stapler

Last updated

Summary

Product
Da Vinci Xi/X Sureform 45/60 Stapler
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Da Vinci Xi/X Sureform 60 Stapler

Multiple lots, contact manufacturer.

480460-09

Da Vinci Xi/X Sureform 45 Stapler

Multiple lots, contact manufacturer.

480445-04
480545-04

Issue

Intuitive has observed an increase in complaints regarding engagement failures associated with Da Vinci x/xi Sureform 45 and 60 stapler instruments. This is related to specific lots and as a precautionary measure, this notice is being sent to raise awareness that there may be increased occurrences of these instruments failing to engage to the system.

Recall start date: October 18, 2022

Additional information

Details
Original published date: 2022-11-02
Alert / recall type
Health product recall
Category
Health product - Medical device - General and plastic surgery
Companies

Intuitive Surgical Inc.

1266 Kifer Road, Sunnyvale, California, United States, 94086

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72140