Sureform 45/60
Brand(s)
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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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
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