Health product recall

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: 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