Public recall detail

Coolsculpting System - Applicator - Vacuum

medium
Recall Safety notice
Quick summary

Quick summary: Coolsculpting System - Applicator - Vacuum.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Coolsculpting System - Applicator - Vacuum.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAmd Medicom Inc.
ProductCoolsculpting System - Applicator - Vacuum
IssueMedical devices - Performance
Recall classType II
IdentificationRA-64287

Affected products

ProductCoolsculpting System - Applicator - Vacuum
LotAll lots.
ModelBRZ-AP1-063-000 BRZ-AP1-062-000 BRZ-AP1-066-000 BRZ-AP1-080-000 BRZ-AP1-064-000
Serial numberAll lots.
DescriptionCoolsculpting System - Applicator - Vacuum

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Physical medicine
CompaniesZeltiq Aesthetics, Inc. 4410 Rosewood Drive, Pleasanton, California, United States, 94588
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64287
Background{}
CompaniesZeltiq Aesthetics, Inc. 4410 Rosewood Drive, Pleasanton, California, United States, 94588
AudiencesHealthcare
Source updated2022-06-20

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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