Health product recall

Sureform 45/60

Last updated

Summary

Product
Sureform 45/60
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Sureform 45

T91211122, L90211027, T90211122, T90211201

480445, 480545

Sureform 60

L93220105, L90211213, L90211013, L91211004, T91211102

480460

Issue

A review of complaints on Sureform PNs 480445, 480545, 480460 was done to determine rate of harm due to tissue pushout events. This action was completed as part of an internal capa. Sureform complaint data from October 1, 2019 through September 30, 2021 was reviewed. 

Overall rate of harm associated with bleeding (tissue pushout events) of critical severity exceeds the predicted likelihood of harm as documented.

Recall start date: Mar 17, 2022

Additional information

Details
Original published date: 2022-04-07
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
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64037