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Health Canada Medical devices

Coolsculpting System - Applicator - Vacuum

Issued June 20, 2022
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
Hazard description
Performance
Product
Product name
Coolsculpting System - Applicator - Vacuum
Reference
ID
RA-64287