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 BRZ-AP1-062-000 BRZ-AP1-066-000 BRZ-AP1-080-000 BRZ-AP1-064-000 |
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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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
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