Coolsculpting System - Applicator - Vacuum
Brand(s)
Last updated
Summary
Product
Coolsculpting System - Applicator - Vacuum
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 |
|---|---|---|
Coolsculpting System - Applicator - Vacuum |
All lots. |
BRZ-AP1-063-000 |
Issue
Zeltiq Aesthetics, Inc. is voluntarily discontinuing and recalling Coolsculpting parallel plate applicators (Coolcore, Coolcurve, Coolcurve+, Coolmax, and Coolfit applicators) due to the observance of a slightly increased rate of paradoxical hyperplasia during a recent analysis of data from the 2019-2021 timeframe.
Recall start date: June 13, 2022
Additional information
Details
Original published date: 2022-06-23
Alert / recall type
Health product recall
Category
Health product - Medical device - Physical medicine
Companies
Zeltiq Aesthetics, Inc.
4410 Rosewood Drive, Pleasanton, California, United States, 94588
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64287